sssohrab/ct-dosing-errors-benchmark · Datasets at Hugging Face

[ 4 ]

191

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The current trial will examine the efficacy and safety of Exubera administered as a mealtime insulin compared to lispro, when added to an existing regimen of basal insulin glargine + or = Oral Agents (OAs). Dose titrations will be provided which should allow a large proportion of subjects to reach target glycosylated hemoglobin (A1C) levels.

null

Diabetes Mellitus

type two diabetes, insulin, HbA1c

null

2

arm 1: Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents. arm 2: Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents. intervention 2: Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.

intervention 1: Insulin Lispro intervention 2: Exubera

63

0

NCT00348374

[ 5 ]

106

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.

null

Diabetes Mellitus, Type 2

null

2

arm 1: Bolus arm arm 2: Control arm

[ 5, 5 ]

4

[ 0, 0, 0, 0 ]

intervention 1: One daily injection at bedtime intervention 2: At same dosage as during the run-in period intervention 3: One bolus given before the main meal intervention 4: At same dosage as during the run-in period

intervention 1: Insulin Glargine intervention 2: Glimepiride intervention 3: Insulin Glulisine intervention 4: Metformin

3

Bridgewater | New Jersey | United States | -74.64815 | 40.60079 Moscow | N/A | Russia | 37.61556 | 55.75222 Guildford | N/A | United Kingdom | -0.57427 | 51.23536

0

NCT00360698

[ 4 ]

108

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

GAD subjects maintained on a stable dose of alprazolam for at least four weeks who meet eligibility criteria will be randomized to receive pregabalin vs matching placebo while simultaneously tapering off of alprazolam over 6 weeks. Subjects return weekly for assessment of safety/tolerability of pregabalin vs placebo as well as for assessment of anxiety and benzodiazepine withdrawal symptoms. Subjects successfully able to discontinue alprazolam, will continue 6 weeks of treatment with pregabalin vs placebo (free of benzodiazepine use). The efficacy and safety of pregabalin vs placebo for anxiety symptoms and ability to discontinue/remain free of alprazolam will be compared among pregabalin and placebo treated groups. Hypothesis is that a greater proportion of subjects will be successful in discontinuing and remaining free from benzodiazepines who were treated with pregabalin as compared to subjects treated with placebo.

null

Generalized Anxiety Disorder

null

2

arm 1: Pregabalin treatment for GAD during 6 week taper/discontinuation from alprazolam treatment; followed by 6 weeks pregabalin treatment 'alprazolam free'. arm 2: Placebo treatment of GAD during 6 week taper/discontinuation of alprazolam treatment followed by 6 weeks continuation of placebo treatment 'alprazolam free'.

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: GAD subjects on stable dose of alprazolam will be randomized to double-blind pregabalin at starting dose of 75mg twice daily. Weekly assessments of tolerability, need for rescue medication, anxiety/withdrawal symptoms will guide flexible dose titration of pregabalin at dose range between 75 and 300mg twice daily. Subjects successful in discontinuation of alprazolam while treated with pregabalin will continue to be maintained on pregabalin for 6 weeks and assessed weekly for ability to remain in the study. intervention 2: GAD subjects on stable dose of alprazolam will be randomized to double-blind placebo matching assessments and study medication titration as detailed under the pregabalin arm description. Subjects successful in discontinuation of alprazolam while treated with placebo will continue to be maintained on placebo for 6 weeks and assessed weekly for ability to remain in the study.

intervention 1: Pregabalin intervention 2: Placebo

21

San Pedro | Provincia de San José | Costa Rica | -84.05074 | 9.92829 Pilsen | N/A | Czechia | 13.37759 | 49.74747 Prague | N/A | Czechia | 14.42076 | 50.08804 Prague | N/A | Czechia | 14.42076 | 50.08804 Prague | N/A | Czechia | 14.42076 | 50.08804 Praha-Bubenec | N/A | Czechia | N/A | N/A Paris | Cedex 12 | France | 2.3488 | 48.85341 Arcachon | N/A | France | -1.17255 | 44.66126 Caen | N/A | France | -0.35912 | 49.18585 Élancourt | N/A | France | 1.9552 | 48.78421 Nantes-Orvault | N/A | France | N/A | N/A Guatemala City | N/A | Guatemala | -90.51327 | 14.64072 L’Aquila | N/A | Italy | 13.39954 | 42.35055 Milan | N/A | Italy | 9.18951 | 45.46427 Tepic | Nayarit | Mexico | -104.89332 | 21.50733 Mexico City | N/A | Mexico | -99.12766 | 19.42847 San Luis Potosí City | N/A | Mexico | -100.97135 | 22.15234 Langreo | Principality of Asturias | Spain | -5.68416 | 43.29568 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Zamora | N/A | Spain | -5.74456 | 41.50633

0

NCT00368745

[ 3 ]

35

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

2DOUBLE

true

0ALL

null

The purpose of this study is to investigate whether or not marijuana blunts will produce comparable plasma THC levels as marijuana joints and if blunts will produce larger cardiovascular and subjective effects.

There has been a rapid increase in marijuana use during the 1990s, with the most recent generation often smoking marijuana in the form of 'blunts' as opposed to more traditional routes such as in pipes or in cigarette paper. A blunt is made by removing the tobacco from a cigar and replacing it with marijuana (Golub and Johnson, 1999). The cigar wrapper contains tobacco and nicotine, which may interact with the cardiovascular and subjective effects of the marijuana to produce a different set of effects and risks than cigarette paper. Anecdotally, marijuana smokers report that blunts are more potent than joints, yet there have been no controlled studies addressing whether blunts enhance the subjective-effects and health-related consequences of marijuana use. We are proposing to do a within-subject, placebo-controlled study directly comparing the cardiovascular, subjective and pharmacokinetic effects of marijuana smoked in blunts compared to identical quantities of marijuana smoked in cigarette paper. Research volunteers will be current blunt smokers. Each will participate in six, 4-hour outpatient sessions. After baseline data have been collected (heart rate, blood pressure, mood scales, exhaled carbon monoxide, plasma THC and nicotine levels), participants will take 3 puffs, 5 seconds in duration, from a NIDA marijuana cigarette containing 0.0, 1.8 and 3.6% THC or from a blunt containing an equivalent quantity and strength of marijuana. Participants will be blind to the type of marijuana cigarette smoked. We will measure plasma THC and nicotine, subjective mood ratings, and heart rate and blood pressure repeatedly over the course of 180 minutes following smoking. This study is the first controlled investigation of the consequences of this new method of marijuana smoking; the data obtained may be useful in guiding future development of marijuana pharmacotherapy.

Marijuana Dependence

Marijuana Comparison between joints and blunts Pharmacokinetic effects

null

2

arm 1: marijuana blunt (0%, 1.8%, or 3.6% THC) arm 2: marijuana cigarette (0%, 1.8%, or 3.6% THC)

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Blunts were fabricated by cutting the bottom third off a Dutch Master® cigar, removing all of the cigar tobacco, and replacing it with all of the marijuana contained in a NIDA marijuana cigarette (ca. 800 mg). intervention 2: Marijuana cigarettes were provided by the National Institute on Drug Abuse.

intervention 1: Marijuana blunt intervention 2: marijuana cigarette

1

New York | New York | United States | -74.00597 | 40.71427

0

NCT00374127

[ 4 ]

43

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration \[FDA\] for the treatment of hepatitis B virus \[HBV\]) versus adefovir dipivoxil used alone. The results for patients taking the combination therapy will be compared to the results for patients taking adefovir alone.

null

Hepatitis B

lamivudine resistance Hepatitis B virus

null

2

arm 1: Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks. arm 2: Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 600mg/day oral tablet for 96 weeks intervention 2: 10 mg of adefovir by mouth once daily

intervention 1: telbivudine intervention 2: adefovir dipivoxil

6

San Diego | California | United States | -117.16472 | 32.71571 San Mateo | California | United States | -122.32553 | 37.56299 Pok Fu Lam | N/A | Hong Kong | 114.12924 | 22.26861 Seoul | N/A | South Korea | 126.9784 | 37.566 Kaohsuing | N/A | Taiwan | N/A | N/A Bangkok | N/A | Thailand | 100.50144 | 13.75398

0

NCT00376259

[ 5 ]

356

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

false

1FEMALE

null

This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12 weeks; they will then cross over to receive the alternative treatment for a further 12 weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

null

Post Menopausal Osteoporosis

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 35mg po weekly for 12 weeks intervention 2: 150mg po monthly for 3 months

intervention 1: Risedronate intervention 2: ibandronate [Bonviva/Boniva]

48

0

NCT00377234

[ 4 ]

746

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled, parallel-group study, evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind Treatment Period, participants will receive open-label (OL) MF MDI 100 mcg twice daily (BID) for 2 to 3 weeks during the Run-in Period. Efficacy will be measured by the Area Under the Curve from 0 to 12 hours \[AUC\](0-12 hours) of the change from Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1) and by the time-to-first severe asthma exacerbation across the 26-week treatment period.

null

Asthma

null

4

arm 1: None arm 2: None arm 3: None arm 4: None

[ 0, 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: MF/F 100/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks intervention 2: MF 100 mcg via metered dose inhaler twice daily for 26 weeks intervention 3: F via metered dose inhaler 10 mcg twice a day for 26 weeks intervention 4: Placebo metered dose inhaler twice a day for 26 weeks

intervention 1: Mometasone Furoate/Formoterol Fumarate Combination MDI 100/10 mcg BID intervention 2: Mometasone Furoate MDI (MF MDI) intervention 3: Formoterol Fumarate 10 mcg intervention 4: Placebo

0

null

0

NCT00383552

[ 4 ]

1,080

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to investigate the efficacy of inhaled ciclesonide at three different dose levels compared with placebo with respect to pulmonary function, asthma symptoms, and use of rescue medication in children aged 6-11 years with asthma. Treatment medication will be administered as follows: ciclesonide or placebo will be inhaled once daily in the evening. The study consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study provides further data on safety and tolerability of ciclesonide.

The drug being tested is called ciclesonide. This study looked at the safety and efficacy of inhaled ciclesonide in children with asthma. The study enrolled 1080 patients. Participants were randomly assigned to 1 of 4 treatment groups which were undisclosed to the patient and study doctor during the study:• Ciclesonide 40 µg, 80 µg or 160 µg • Placebo- this is similar to study drug but has no active ingredient. Ciclesonide was inhaled via a metered-dose inhaler (MDI with HFA-134a propellant), with or without spacer, once daily in the evening throughout the study. All participants were asked to document daily AM and PM peak expiratory flow (PEF), daytime and nighttime asthma symptom scores and number of puffs of rescue medicine in an electronic diary. This multi-centre trial was conducted worldwide. The overall time to participate in this study was 20 weeks. Participants made multiple visits to the clinic plus a final visit 30 days after the last dose of study drug for a follow-up assessment.

Asthma

Asthma Ciclesonide children

null

4

arm 1: Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. arm 2: Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. arm 3: Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. arm 4: Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

[ 1, 1, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: inhaled Ciclesonide intervention 2: Ciclesonide placebo-matching inhaler intervention 3: Salbutamol inhalation powder

intervention 1: Ciclesonide intervention 2: Placebo intervention 3: Salbutamol

122

Plovdiv | N/A | Bulgaria | 24.75 | 42.15 Plovdiv | N/A | Bulgaria | 24.75 | 42.15 Rousse | N/A | Bulgaria | 25.9534 | 43.84872 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Vama | N/A | Bulgaria | N/A | N/A Dresden | N/A | Germany | 13.73832 | 51.05089 Freising | N/A | Germany | 11.74876 | 48.40351 Fulda | N/A | Germany | 9.67518 | 50.55162 Homburg | N/A | Germany | 7.33867 | 49.32637 Kassel | N/A | Germany | 9.5 | 51.31667 Leipzig | N/A | Germany | 12.37129 | 51.33962 Mannheim | N/A | Germany | 8.46694 | 49.4891 Marburg | N/A | Germany | 8.77069 | 50.80904 München | N/A | Germany | 13.31243 | 51.60698 Rosenheim | N/A | Germany | 12.12247 | 47.85637 Schwäbisch Hall | N/A | Germany | 9.73908 | 49.11127 Welzheim | N/A | Germany | 9.63434 | 48.87675 Wesel | N/A | Germany | 6.62037 | 51.6669 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Debrecen | N/A | Hungary | 21.62444 | 47.53167 Jászberény | N/A | Hungary | 19.91667 | 47.5 Kiskunhalas | N/A | Hungary | 19.48479 | 46.43402 Miskolc | N/A | Hungary | 20.77806 | 48.10306 Mosdós | N/A | Hungary | 17.98853 | 46.35379 Mosonmagyaróvár | N/A | Hungary | 17.26994 | 47.86789 Pécs | N/A | Hungary | 18.23083 | 46.0725 Szeged | N/A | Hungary | 20.14824 | 46.253 Inowrocław | N/A | Poland | 18.26387 | 52.79886 Lodz | N/A | Poland | 19.47395 | 51.77058 Lodz | N/A | Poland | 19.47395 | 51.77058 Lublin | N/A | Poland | 22.56667 | 51.25 Poznan | N/A | Poland | 16.92993 | 52.40692 Torun | N/A | Poland | 18.59814 | 53.01375 Warsaw | N/A | Poland | 21.01178 | 52.22977 Warsaw | N/A | Poland | 21.01178 | 52.22977 Zawadzkie | N/A | Poland | 18.48467 | 50.60503 Brasov | N/A | Romania | 25.60613 | 45.64861 Bucharest | N/A | Romania | 26.10626 | 44.43225 Bucharest | N/A | Romania | 26.10626 | 44.43225 Bucharest | N/A | Romania | 26.10626 | 44.43225 Bucharest | N/A | Romania | 26.10626 | 44.43225 Bucharest | N/A | Romania | 26.10626 | 44.43225 Bucharest | N/A | Romania | 26.10626 | 44.43225 Cluj-Napoca | N/A | Romania | 23.6 | 46.76667 Cluj-Napoca | N/A | Romania | 23.6 | 46.76667 Craiova | N/A | Romania | 23.8 | 44.31667 Galati | N/A | Romania | 28.05028 | 45.43687 Iași | N/A | Romania | 27.6 | 47.16667 Sibiu | N/A | Romania | 24.15 | 45.8 Chelyabinsk | N/A | Russia | 61.42915 | 55.15402 Ivanovo | N/A | Russia | 40.97139 | 56.99719 Kislovodsk | N/A | Russia | 42.72083 | 43.91333 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Murmansk | N/A | Russia | 33.09747 | 68.97398 Novosibirsk | N/A | Russia | 82.94339 | 55.03442 Rostov | N/A | Russia | 39.41307 | 57.19081 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Samara | N/A | Russia | 50.15 | 53.20007 Smolensk | N/A | Russia | 32.04371 | 54.77944 Tomsk | N/A | Russia | 84.98204 | 56.50032 Vladimir | N/A | Russia | 40.39658 | 56.13655 Voronezh | N/A | Russia | 39.1843 | 51.67204 Bellville - Cape Town - | N/A | South Africa | N/A | N/A Bloemfontein | N/A | South Africa | 26.214 | -29.12107 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Centurion | N/A | South Africa | 28.18577 | -25.85891 Durban | N/A | South Africa | 31.0292 | -29.8579 Durban, Amanzimtoti | N/A | South Africa | N/A | N/A Gezina, Pretoria | N/A | South Africa | N/A | N/A Morningside, Sandton | N/A | South Africa | N/A | N/A Mowbray, Cape Town | N/A | South Africa | N/A | N/A New Redruth, Alberton | N/A | South Africa | 28.12225 | -26.26786 Panorama / RSA-Cape Town | N/A | South Africa | N/A | N/A Somerset West | N/A | South Africa | 18.82113 | -34.08401 Westville | N/A | South Africa | 30.937 | -29.82554 Wynberg | N/A | South Africa | 28.08466 | -26.11075 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Esplugues de Llobregat | N/A | Spain | 2.08809 | 41.37732 Leganés | N/A | Spain | -3.7635 | 40.32718 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Manresa | N/A | Spain | 1.82399 | 41.72815 Sabadell (Barcelona) | N/A | Spain | 2.10942 | 41.54329 Tarrasa | N/A | Spain | N/A | N/A Dnipropetrovsk | N/A | Ukraine | 35.04066 | 48.46664 Donetsk | N/A | Ukraine | 37.80224 | 48.023 Donetsk | N/A | Ukraine | 37.80224 | 48.023 Kharkiv | N/A | Ukraine | 36.25475 | 49.98177 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Kyiv | N/A | Ukraine | 30.5238 | 50.45466 Kyiv | N/A | Ukraine | 30.5238 | 50.45466 Kyiv | N/A | Ukraine | 30.5238 | 50.45466 Lviv | N/A | Ukraine | 24.02324 | 49.83826 Odesa | N/A | Ukraine | 30.74383 | 46.48572 Poltava | N/A | Ukraine | 34.55367 | 49.58925 Simferopol | N/A | Ukraine | 34.11079 | 44.95719 Vinnytsia | N/A | Ukraine | 28.46871 | 49.2322 Zaporizhzhya | N/A | Ukraine | 35.11714 | 47.85167

0

NCT00384189

[ 5 ]

261

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes mellitus.

null

Diabetes Mellitus, Type 2

type 2 diabetes, insulin, glycemic control

null

2

arm 1: None arm 2: None

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Patient will be randomized to Lantus® while remaining on pre-study oral hypoglycemic agents. intervention 2: Patient will be randomized inhaled insulin while remaining on pre-study oral hypoglycemic agents.

intervention 1: Insulin Glargine (Lantus®) intervention 2: Inhaled Human Insulin (Exubera®)

62

Bornem | N/A | Belgium | 4.24364 | 51.09716 Brussels | N/A | Belgium | 4.34878 | 50.85045 Genk | N/A | Belgium | 5.50082 | 50.965 Liège | N/A | Belgium | 5.56749 | 50.63373 Kuopio | N/A | Finland | 27.67703 | 62.89238 Lahti | N/A | Finland | 25.66151 | 60.98267 Oulu | N/A | Finland | 25.46816 | 65.01236 Besançon | N/A | France | 6.01815 | 47.24878 Corbeil-Essonnes | N/A | France | 2.48757 | 48.60603 La Rochelle | N/A | France | -1.15222 | 46.16308 Marseille | N/A | France | 5.38107 | 43.29695 Paris | N/A | France | 2.3488 | 48.85341 Valenciennes | N/A | France | 3.52506 | 50.35909 Altenburg | N/A | Germany | 12.43684 | 50.98763 Eisenach | N/A | Germany | 10.31522 | 50.9807 Hamburg | N/A | Germany | 9.99302 | 53.55073 Hohenmölsen | N/A | Germany | 12.1 | 51.15769 Leipzig | N/A | Germany | 12.37129 | 51.33962 Neuss | N/A | Germany | 6.68504 | 51.19807 Riesa | N/A | Germany | 13.29168 | 51.30777 Wangen / Allgaeu | N/A | Germany | N/A | N/A 's-Hertogenbosch | N/A | Netherlands | 5.30417 | 51.69917 Eindhoven | N/A | Netherlands | 5.47778 | 51.44083 Nijmegen | N/A | Netherlands | 5.85278 | 51.8425 The Hague | N/A | Netherlands | 4.29861 | 52.07667 Venlo | N/A | Netherlands | 6.16806 | 51.37 Hønefoss | Buskerud | Norway | 10.25647 | 60.16804 Bergen | N/A | Norway | 5.32415 | 60.39299 Jessheim | N/A | Norway | 11.17515 | 60.14151 Lysaker | N/A | Norway | 10.63545 | 59.90994 Skedsmokorset | N/A | Norway | 11.03278 | 60.00459 Lodz | N/A | Poland | 19.47395 | 51.77058 Lodz | N/A | Poland | 19.47395 | 51.77058 Lublin | N/A | Poland | 22.56667 | 51.25 Warsaw | N/A | Poland | 21.01178 | 52.22977 Łask | N/A | Poland | 19.13278 | 51.59056 A Coruña | A Coruña | Spain | -8.396 | 43.37135 Palma de Mallorca | Balearic Islands | Spain | 2.65024 | 39.56939 Huelva | Huelva | Spain | -6.94004 | 37.26638 Málaga | Malaga | Spain | -4.42034 | 36.72016 Inca | Mallorca | Spain | 2.91093 | 39.7211 San Cristóbal de La Laguna | Santa Cruz de Tenerife | Spain | -16.32014 | 28.4853 Alzira | Valencia | Spain | -0.43333 | 39.15 Valencia | Valencia | Spain | -0.37966 | 39.47391 Borås | N/A | Sweden | 12.9401 | 57.72101 Eksjö | N/A | Sweden | 14.97205 | 57.66643 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Härnösand | N/A | Sweden | 17.93794 | 62.63228 Helsingborg | N/A | Sweden | 12.69437 | 56.04673 Järfälla | N/A | Sweden | N/A | N/A Kristianstad | N/A | Sweden | 14.15242 | 56.03129 Linköping | N/A | Sweden | 15.62157 | 58.41086 Luleå | N/A | Sweden | 22.15465 | 65.58415 Malmo | N/A | Sweden | 13.00073 | 55.60587 Motala | N/A | Sweden | 15.03649 | 58.53706 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Uddevalla | N/A | Sweden | 11.9424 | 58.34784 Umeå | N/A | Sweden | 20.25972 | 63.82842 Vaxjo | N/A | Sweden | 14.80906 | 56.87767 Bruderholz | N/A | Switzerland | 7.59902 | 47.5296 Sankt Gallen | N/A | Switzerland | 9.37477 | 47.42391

0

NCT00391027

[ 4 ]

128

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

null

Efficacy/ safety for the combination of anti-IgE (Omalizumab) and specific immunotherapy (Depigoid) in patients with not adequately controlled seasonal allergic asthma and comorbid seasonal allergic rhinoconjunctivitis.

This was an open-label extension period of the previously randomized, multicenter, double-blind, placebo-controlled, parallel-group trial to demonstrate the benefit of pre- and co-seasonal combination therapy with anti-IgE (omalizumab) and specific immunotherapy (Depigoid) in patients with seasonal allergic asthma and co-morbid seasonal allergic rhinoconjunctivitis. During the open-label period, all patients received Depigoid monotherapy for two follow-up seasons every 4 weeks, 26 injections in total. The extension period was performed to evaluate the influence of omalizumab on the follow-up treatment with Depigoid in seasonal asthma. This study was a follow-up to the core IGE025ADE03 study, in which patients received omalizumab treatment. In this follow-up study, no patient received omalizumab.

Allergic Asthma

null

2

arm 1: Xolair® (Omalizumab, double-blind core study period only), Depigoid® (grass/rye pollen 50/50) arm 2: Depigoid® (grass/rye pollen 50/50) + Placebo

[ 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL) intervention 2: anti-IgE (Omalizumab) given during the 2006 core study intervention 3: Placebo given during the 2006 core study

intervention 1: Depigoid intervention 2: Omalizumab intervention 3: Placebo

1

Nuremberg | N/A | Germany | 11.07752 | 49.45421

0

NCT00396409

[ 3 ]

200

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

2MALE

false

This study examined the safety, tolerability, and efficacy of mirabegron (YM178) compared to placebo.

null

Lower Urinary Tract Symptoms Bladder Outlet Obstruction

Beta-3 Receptor Agonist YM178 Men Lower Urinary Tract Symptoms Bladder Outlet Obstruction

null

3

arm 1: Participants received matching mirabegron placebo tablets orally once daily for 12 weeks. arm 2: Participants received 50 mg mirabegron tablets orally once daily for 12 weeks. arm 3: Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.

[ 2, 0, 0 ]

2

[ 0, 0 ]

intervention 1: oral intervention 2: oral

intervention 1: Mirabegron intervention 2: Placebo

27

0

NCT00410514

[ 4 ]

2,281

RANDOMIZED

PARALLEL

1PREVENTION

0NONE

true

1FEMALE

false

The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged 18-50 years.

null

Contraception

null

2

arm 1: Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic combined oral contraceptive arm 2: Drospirenone (DRSP) and Ethinyl Estradiol (EE), 3 mg DRSP and 30 mcg EE monophasic combined oral contraceptive

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year). intervention 2: Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year).

intervention 1: NOMAC-E2 intervention 2: DRSP-EE

0

null

0

NCT00413062

[ 3 ]

509

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to determine the effectiveness and safety, over 6 months, of 6 dose regimens of CP-690,550, combined with methotrexate, for the treatment of adults with active rheumatoid arthritis.

null

Arthritis, Rheumatoid

DMARD therapy

null

7

arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: Dummy tablets

[ 0, 0, 0, 0, 0, 0, 2 ]

7

[ 0, 0, 0, 0, 0, 0, 10 ]

intervention 1: 4 blinded tablets administered BID intervention 2: 4 blinded tablets administered BID intervention 3: 4 blinded tablets administered BID intervention 4: 4 blinded tablets administered BID intervention 5: 4 blinded tablets administered BID intervention 6: Oral tablets intervention 7: Placebo

intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: CP-690,550 intervention 5: CP-690,550 intervention 6: CP-690,550 intervention 7: placebo

82

0

NCT00413660

[ 0 ]

130

RANDOMIZED

PARALLEL

1PREVENTION

3TRIPLE

true

0ALL

true

The purpose of this study is to investigate the efficacy of Flavangenol® (Toyo Shinyaku, Japan), a pine bark extract, in lowering blood pressure and improving glycemic control and plasma lipoprotein profile.

Cardiovascular disease is the number one cause of death in the Unites States. Our study tests the efficacy of pine bark extract in improving a number of cardiovascular disease risk factors. We are conducting a randomized, placebo-controlled, double-blind, parallel trial that will investigate the efficacy and safety of Flavangenol® (Toyo Shinyaku, Japan), a pine bark extract, among 130 study participants. These participants will be individuals at mildly or moderately elevated risk of cardiovascular disease (CVD) because of having prehypertension, excess body weight, and insulin insensitivity. We aim to determine (in order of priority): 1. The efficacy of Flavangenol in lowering blood pressure. 2. The efficacy of Flavangenol in improving glycemic control and plasma lipoprotein profile. 3. Changes in body weight, antioxidative capacity, anti-inflammatory markers, blood coagulation factors, and liver function tests in response to Flavangenol. 4. The safety of Flavangenol, as confirmation of past studies.

Hypertension

null

2

arm 1: Placebo delivered as four tablets matching the active product once daily orally. arm 2: Flavangenol 200 mg Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets, each containing 50 mg Flavangenol, all 4 tablets taken once per day.

[ 2, 1 ]

1

[ 0 ]

intervention 1: Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets, each containing 50 mg Flavangenol, all 4 tablets taken once per day orally for 12 weeks.

intervention 1: Pine Bark Extract (Flavangenol®)

1

Stanford | California | United States | -122.16608 | 37.42411

0

NCT00425945

[ 0 ]

4

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to determine: 1. whether there is a difference between insulin aspart and insulin lispro in continuous insulin pump therapy 2. whether duration of the insulin infusion set placement effect blood sugar control if the infusion set is in place for longer then 72-96 hours

Insulin instability in pump infusion systems can result in unexplained hyperglycemia in patients on continuous subcutaneous insulin infusion (CSII) therapy. We have noted that some pump patients develop glycemic instability with use of insulin lispro, and that this resolves with change to insulin aspart. Several patients using lispro have reported noting a whitish precipitate in the infusion set, and in two cases we have examined the catheters and confirmed biochemically that this precipitate was insulin. Furthermore, in vitro studies indicate that insulin aspart is more resistant to isoelectric precipitation than insulin lispro. Although it has been rare for patients to notice a visible precipitate in the pump catheter, there is a subset of patients using lispro who have noted that their blood glucose levels will tend to rise 2 or more days after the insertion of a new pump infusion system. These findings mirror bench studies showing that the relative stability differences between aspart and lispro in pump infusion systems becomes more apparent over time. The endpoints examined in previous randomized clinical trials comparing aspart and lispro were not directed specifically at assessing the effect of insulin type on glycemic stability. In these previous studies, pump infusion systems were changed every 48 hours whereas most pump patients routinely replace their infusion catheters only every 72-96 hours; this discrepancy may account for the failure of these trials to demonstrate the difference in the stability of insulin aspart and lispro that has been noted in clinical practice. This investigator-initiated clinical trial is intended to assess the safety and efficacy of CSII with insulin aspart compared to insulin lispro with use of pump infusion catheters for up to 96 hours.

Type 1 Diabetes Mellitus

type 1 diabetes, insulin pump therapy, glycemic stability

null

2

arm 1: Insulin aspart will be used for diabetes management, and will be delivered continuously, subcutaneously using a pump for a four week period. Insulin aspart doses will be adjusted by the principal investigator as needed to maintain glycemic control. Insulin dose adjustments will vary from patient to patient based on the carbohydrate consumption, level of physical activity, and fingerstick monitoring results SMBG (7 times per day). SMBG results collected during this four week period will be compared to the SMBG results collected while participant uses alternative treatment (insulin Lispro). arm 2: Insulin lispro will be used for diabetes management, and will be delivered continuously, subcutaneously using a pump for a four week period. Dose will be adjusted as needed to maintain glycemic control. Insulin dose adjustments will vary from patient to patient based on the carbohydrate consumption, level of physical activity, and fingerstick monitoring results SMBG (7 times per day). SMBG results collected during this four week period will be compared to the SMBG results collected while participant uses alternative treatment (insulin Aspart).

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Subjects will be randomly assigned to insulin aspart versus insulin lispro via random number generation. Half of the patients will begin with insulin aspart, and then will be crossed over to insulin lispro. The insulin sequence will be reversed for the other half of the patients. intervention 2: Subjects will be randomly assigned to insulin lispro versus insulin aspart via random number generation. Half of the patients will begin with insulin lispro, and then will be crossed over to insulin aspart. The insulin sequence will be reversed for the other half of the patients.

intervention 1: Insulin Aspart versus Insulin Lispro intervention 2: Insulin Lispro versus Insulin Aspart

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00428207

[ 0 ]

8

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

The primary objective of this pilot study is to determine whether neoadjuvant capecitabine/oxaliplatin/cetuximab and external beam radiation therapy followed by surgical resection \[and then followed by post operative adjuvant capecitabine, oxaliplatin and cetuximab\] is feasible and tolerable.

It is clear that new approaches are needed to improve the therapeutic ratio in esophageal cancer. This study proposes to evaluate the novel combination of preoperative capecitabine, oxaliplatin, and cetuximab concurrently with radiation therapy. This will be followed by esophagectomy 6-9 weeks after the completion of chemoradiation. Followed by further adjuvant chemotherapy. It is hypothesized that our novel combination of neoadjuvant capecitabine, oxaliplatin, and cetuximab combined with thoracoabdominal radiation therapy will be feasible and result in acceptable toxicity.

Esophageal Adenocarcinoma

Esophageal Esophagus

null

1

arm 1: Patients enrolled on the trial will receive neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This will be followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab

[ 0 ]

3

[ 0, 0, 0 ]

intervention 1: Given 650 mg/m\^2 BID on days of ration therapy, 825 mg/m\^2 day 1-14, day 15-20 off x 4 intervention 2: Oxaliplatin 30 mg/m\^2, 130mg/m2 IV Q 21 days x 4 intervention 3: Initial Cetuximab 400 mg/m\^2 IV starting no earlier than 8 weeks and no later than 10 weeks after surgical resection

intervention 1: Capecitabine intervention 2: Oxaliplatin intervention 3: Cetuximab

1

Aurora | Colorado | United States | -104.83192 | 39.72943

0

NCT00430027

[ 2, 3 ]

9

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to identify the maximum tolerated dosage of sodium phenylbutyrate in children with spinal muscular atrophy types II or III; and to determine if the drug has an effect on SMN mRNA and protein levels.

Spinal muscular atrophy (SMA) is a genetic, neuromuscular disorder caused by progressive degeneration of motor neurons in the spinal cord, which results from the loss of survival motor neuron (SMN) protein. The disorder is characterized by weakness and wasting of the voluntary muscles and is a leading cause of hereditary infant death. Sodium phenylbutyrate--a drug used to treat urea cycle disorders--may increase the amount of SMN protein in the body and consequently may decrease the severity of SMA. However, this has not yet been proven. In this multicenter trial, physicians will evaluate multiple dosage levels of sodium phenylbutyrate to determine the maximum tolerated dose (MTD), or the highest dose that can be safely given to children with SMA types II or III. The initial dosage tested will be 500 mg/kg/day. Depending upon tolerability, subsequent groups may receive dosages of 675, 900, or 1200 mg/kg/day. Blood levels of SMN mRNA and protein will also be measured to determine whether sodium phenylbutyrate can increase the amount of these two biomarkers in the blood. Up to 24 children will be enrolled in the study and will be on sodium phenylbutyrate for 12 weeks. The MTD will be determined based on safety data from Day 0 through the Day 29 visit. Participants will continue to be monitored for safety and SMN mRNA and protein levels through the 12 week study drug administration period. Potential participants will be screened by having their complete medical and treatment histories recorded, as well as undergoing a physical examination, laboratory tests, and an electrocardiogram (EKG). Parents of eligible participants will receive a supply of sodium phenylbutyrate and instructions on how to administer the drug. Participants will return to the clinic on days 8, 22, 29, and at weeks 8 and 12 of the study to update their medical and treatment histories, have a physical exam, and have blood and urine collected for laboratory testing. A follow-up clinic visit will occur approximately 14 days after the last dose of sodium phenylbutyrate is given. During this visit participants will update their complete medical and treatment histories and have a physical examination. Duration of the study is about 14 weeks. Information from this study, which is part of the NINDS Pilot Therapeutics Network (NPTUNE), may be used for future studies to determine if sodium phenylbutyrate is effective for treating SMA, and if the drug has an effect on SMA symptoms.

Spinal Muscular Atrophy Type II Spinal Muscular Atrophy Type III

spinal muscular atrophy type II/III SMA type II/III spinal muscular atrophy SMA sodium phenylbutyrate motor neuron disease neuromuscular survival motor neuron SMN dose escalation

null

1

arm 1: Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The dosage of the next cohort was determined by the Modified Continual Re-assessment Method (MCRM) calculation and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage.

[ 0 ]

1

[ 0 ]

intervention 1: 500 mg/kg/day, depending upon tolerability subsequent dosages may increase to 675, 900, or 1200 mg/kg/day to identify maximum tolerated dose (MTD) and then an additional 6 participants will enroll at the MTD

intervention 1: sodium phenylbutyrate

5

0

NCT00439569

[ 2 ]

25

NON_RANDOMIZED

SEQUENTIAL

0TREATMENT

0NONE

false

0ALL

true

Phase I study of lapatinib and gemcitabine for patients with metastatic pancreaticobiliary cancer.

To evaluate the safety/tolerability and potential antitumor activity of lapatinib, at dose ranges of 1000 to 1500 mg/d, in combination with gemcitabine and gemcitabine/oxaliplatin (GEMOX) in patients with advanced pancreaticobiliary cancer.

Metastatic Pancreatic Cancer

Pancreatic Cancer

null

4

arm 1: Gemcitabine 1000mg/m2 with lapatinib 1000mg/d weekly x 3 weeks arm 2: Gemcitabine 1000mg/m2 with lapatinib 1500mg/d weekly X 3 weeks arm 3: gemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2 on days 1 and 14 of a 28-day cycle with lapatinib 1000 mg/d arm 4: gemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2 on days 1 and 14 of a 28-day cycle with lapatinib 1500 mg/d

[ 0, 0, 0, 0 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: 1000mg/m2 30 minutes intervention 2: 1000mg/d intervention 3: 1500mg/d intervention 4: 1000mg/m2 100minutes intervention 5: 100mg/m2

intervention 1: Gemcitabine 1000mg/m2 30 minutes intervention 2: Lapatinib 1000mg/d intervention 3: Lapatinib 1500mg/d intervention 4: Gemcitabine 1000mg/m2 100minutes intervention 5: Oxaliplatin 100mg/m2

1

Providence | Rhode Island | United States | -71.41283 | 41.82399

0

NCT00447122

[ 3 ]

75

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

false

0ALL

true

The primary objective of this study was to assess the efficacy and safety of 2 dose levels of ecallantide versus placebo in reducing blood loss following cardiopulmonary bypass (CPB), as measured by chest tube drainage during the first 12 hours postoperatively or until the chest tube was removed, whichever came first, in patients undergoing primary coronary artery bypass grafting (CABG), single valve repair, or single valve replacement. The secondary objective was to compare the efficacy of all ecallantide-treated participants (pooled high and low-doses) to placebo and to compare the high-dose to the low-dose ecallantide group. Other secondary objectives were to evaluate pharmacokinetics and antibody formation.

This was a Phase 2, randomized, double-blind, placebo-controlled, multi-center study designed to assess the efficacy and safety of 2 dose levels of ecallantide compared to placebo in reducing chest tube drainage in participants requiring CPB for primary CABG, single valve repair, or single valve replacement. Participants were randomized in a 3:3:2 ratio to ecallantide high-dose regimen (maximum 91 mg), ecallantide low-dose regimen (maximum 15 mg), or placebo. Randomization was stratified by surgical procedure so that participants undergoing valve replacement would be evenly distributed across treatment arms. Each participant received active drug or placebo administered in stages on the day of the surgical procedure after induction of anesthesia (Day 1). Participants were screened up to 14 days prior to surgery. Additional study procedures were conducted on Day -1 or 1, peri-operatively, during the immediate postoperative period, and on Days 2, 4, and 7 (or at the time of discharge from the hospital), and between Days 28 and 43 (follow-up).

Blood Loss, Surgical

null

3

arm 1: Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 milliliters per hour (mL/hr) for 4 hours. arm 2: Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 milliliters per hour (mL/hr) for 4 hours. arm 3: Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.

[ 0, 0, 2 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Ecallantide intervention 2: Placebo

15

0

NCT00448864

[ 5 ]

31

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This study will evaluate whether conversion from cyclosporine, a calcineurin inhibitor (CI) to sirolimus (SRL) results in improved long-term renal function without a negative impact on safety or immunosuppressive efficacy, and to further examine the potential of SRL to reduce the severity and/or progression of chronic allograft nephropathy (CAN).

This open-label, randomized, parallel-group, comparative, outpatient study will be conducted in multiple centers in Taiwan. The study will randomize approximately 120 patients. 80 patients will be randomized to the SRL therapy group (conversion from CI- to SRL-based immunosuppression: group A) and 40 patients to the CI therapy group (continued CI therapy: group B). Dosage and Administration SRL Therapy: At the time of randomization on day 1, each patient will have been receiving: * triple therapy with a CI (tacrolimus or CsA) that began at the time of transplantation or within 2 weeks thereafter AND * corticosteroids corresponding to a dosage range of 2.5 to 15 mg/day for prednisone or prednisolone (2 to 12 mg/day for methylprednisolone) or the alternate day equivalent for at least 12 weeks before randomization, PLUS * either MMF (minimum dose 500 mg/day)/MPS (minimum dose 360 mg/day) or AZA (minimum dose 50 mg/day) for at least 12 weeks before randomization. SRL will be added to the immunosuppressive regimen for Group A. Group B will continue on this CI immunosuppressive regimen.

Kidney Transplantation

null

2

arm 1: Sirolimus therapy arm 2: Calcineurin Inhibitor therapy (either cyclosporine or tacrolimus)

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Corticosteroids will be administered according to local practice, within a daily maintenance dosage range of 2.5 to15 mg for prednisone or prednisolone (2 to 12 mg/day for methylprednisolone) or the alternate day equivalent. intervention 2: The maintenance dose of: 1. MMF will not exceed 1500 mg/day or PMS will not exceed 1080 mg/day 2. AZA will not exceed 75 mg/day Thereafter, at the discretion of the investigator, MMF/MPS or AZA may be: 1. continued for the entire 104-week period of randomized therapy 2. subsequently discontinued 3. restarted after discontinuation

intervention 1: Sirolimus+MMF or MPS or AZA+Steroid intervention 2: Calcineurin Inhibitors (either cyclosporine or tacrolimus)+MMF or MPS or AZA+Steroid

1

Select Cities | N/A | Taiwan | N/A | N/A

0

NCT00452361

[ 4 ]

395

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of Tapentadol (CG5503) extended release (ER) (base) compared to placebo in patients with moderate to severe pain from diabetic peripheral neuropathy.

The primary objective of this randomized-withdrawal (randomized means study medication assigned to patients by chance and withdrawal means to stop using), multicenter, double-blind (neither patient nor investigator knows the study medication), placebo-controlled, Phase 3 study is to determine the effectiveness and safety of orally administrated Tapentadol (CG5503) extended release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe pain from diabetic peripheral neuropathy. The study is being conducted for registration and approval of CG5503 in the US and outside US. The trial will consist of two phases: Phase I is open-label and Phase 2 is double- blind. In the Open-Label Phase 1 there will be four periods: screening (to assess eligibility), washout (dependent on the pain medication the patient was previously taking), pain intensity perctoris evaluation (over a 3 day period), and open-label titration (study drug will be titrated to an optimal dose starting with 50 mg twice a day and adjusted to an optimal dose for a period of 3 weeks). Patients with at least a 1-point reduction in the average pain intensity score at the end of the open-label titration period, as compared with pre-titration will be eligible for randomization in the double-blind phase. In the double-blind Phase 2, there will be two periods: double-blind maintenance period (take drug for 12 weeks), and follow-up (a visit within 4 days of the intake of the last dose of study drug and a follow-up call approximately 10-14 days after the intake of the last dose of the study drug). The patient will maintain the dose level achieved at the end of the Phase 1 during the double-blind treatment phase. The study hypothesis is that the study drug will be different from placebo in the change in pain intensity. Titrate Tapentadol (CG5503) extended release (ER) 50 mg to patient's optimal dose ranging between 100mg and 250mg twice a day; Placebo (no active ingredients). All doses of trial treatment will be taken orally with or without food, for a maximum timeframe of 15 weeks.

Diabetic Neuropathy

Diabetic neuropathy Painful Diabetic Polyneuropathy Polyneuropathy Peripheral neuropathy

null

2

arm 1: placebo matching placebo twice daily for 12 weeks arm 2: CG5503 100, 150, 200, 250mg twice daily given for up to 15 weeks

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: 100, 150, 200, 250 mg twice daily given for up to 15 weeks intervention 2: matching placebo twice daily for 12 weeks

intervention 1: CG5503 intervention 2: placebo

0

null

0

NCT00455520

[ 2, 3 ]

36

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

Phase I;To investigate the clinically recommended dose of Sunitinib malate (SU011248) following multiple oral dosing in the first cycle (4 consecutive weeks and 2 weeks rest) by reviewing the safety and tolerability. Phase II;To determine the objective tumor response and the safety of Sunitinib malate (SU011248) at the clinically recommended dose.

null

Gastrointestinal Stromal Tumors

Evaluate of RTD for Japanese GIST patients

null

1

arm 1: 25 , 50 or 75 mg/day of SU011248

[ 0 ]

1

[ 0 ]

intervention 1: SU011248

intervention 1: Sunitinib malate (SU011248)

4

0

NCT00457743

[ 3 ]

39

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

true

The purpose of this study was to evaluate the safety and tolerability of ivacaftor in patients with cystic fibrosis (CF) who were aged 18 years or older and have a G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.

This was a double-blind, placebo-controlled, cross-over, multiple dose study of up to 28 days of dosing, in subjects with cystic fibrosis (CF) who have a G551D-CTFR gene mutation. Enrollment of 39 subjects occurred at 15 centers in the US, Canada, and Germany. The study was conducted in 2 parts: * Part 1 consisted of Group A and Group B. Subjects in Group A (10 subjects) were randomized to receive 25 mg of ivacaftor every 12 hours \[q12h\] (4 subjects), 75 mg of ivacaftor q12h (4 subjects), or placebo (2 subjects) for 14 days. Following a 7- to 28-day washout period, subjects who received active study drug crossed over to the alternate dose strength of ivacaftor for an additional 14 days. Placebo subjects continued to receive placebo for an additional 14 days. Subjects in Group B (10 subjects) were randomized to receive 75 mg of ivacaftor q12h (4 subjects), 150 mg of ivacaftor q12h (4 subjects), or placebo (2 subjects) for 14 days. Following a 7- to 28-day washout period, the subjects who received active study drug crossed over to the alternate dose strength of ivacaftor for an additional 14 days. Placebo subjects continued to receive placebo for an additional 14 days. * Part 2 consisted of Group C; these subjects did not participate in Part 1. Subjects were randomized to receive 150 mg of ivacaftor q12h (7 subjects), 250 mg of ivacaftor q12h (7 subjects), or placebo (4 subjects) for a total of 28 days. Ivacaftor doses studied in Part 2 were selected following an interim pharmacokinetic/pharmacodynamic (PK/PD) and statistical analyses of data from Part 1. The 2 doses selected for Part 2 were anticipated to enable better definition of the optimal therapeutic dose.

Cystic Fibrosis

G551D mutation Fibrosis Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes

null

4

arm 1: Subjects in Part 1 who first received 25 mg or 75 mg of ivacaftor every 12 hours (q12h) for 14 days, then crossed over to receive the alternate dose for another 14 days. arm 2: Subjects in Part 1 who first received 75 mg or 150 mg of ivacaftor q12h for 14 days then crossed over to receive the alternate dose for another 14 days. arm 3: Subjects in Part 2 who received 150 mg or 250 mg of ivacaftor q12h for 28 days. arm 4: Subjects who received placebo in Part 1 and subjects who received placebo in Part 2.

[ 0, 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 25 mg or 75 mg q12h for a total of 28 days (Part 1) intervention 2: 75 mg or 150 mg q12h for a total of 28 days (Part 1) intervention 3: 150 mg or 250 mg of ivacaftor q12h for 28 days (Part 2) intervention 4: Given q12h for 28 days each in Part 1 and Part 2 of the study

intervention 1: Ivacaftor 25 mg/75 mg intervention 2: Ivacaftor 75 mg/150 mg intervention 3: Ivacaftor 150 mg or 250 mg intervention 4: Placebo

15

0

NCT00457821

[ 5 ]

20

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

true

The purpose of the study is to compare the glycemic control between insulins aspart and lispro 48 to 100 hours after pump infusion line change in subjects with type 1 using diabetes using an insulin pump.

Continuous subcutaneous insulin infusion (Insulin pump therapy) is a well established tool for the management of type 1 diabetes. In clinical trials, insulin pump therapy has been shown to have increased efficacy over multiple daily injections. However, the overall glycemic control in patients using insulin pumps has been disappointing. The recommended duration of "needle use" in insulin pump treatment is 48 hours, based on anecdotal observations. One of the reasons for the suboptimal control may be that patients do not adhere to the advice of changing their pump infusion line every 48 hours. However, it is possible that the loss of glycemic control may be related to instability of insulin in the pump/line. In addition to premeal loss of control after 48 hours of line change, very little is known about post-prandial hyperglycemia leading to loss of efficacy of the insulin via an insulin pump bolus. The development of continuous glucose monitoring system (CGMS) and new tests for short term fluctuations in glucose control such as 1,5-anhydroglucitol make it easier to evaluate the impact of short term loss of control in patients using the insulin pump who delay changing their lines. The different variables will be compared between the two insulins using a paired t test. 1. Glycemic control will be will be compared 24 to 100 hours after pump infusion line change using CGMS and daily serum 1,5-anhydroglucitol. 2. Post prandial glycemic excursions in plasma glucose following a standardized breakfast 48, 72, and 96 hours after a pump infusion line change will be compared. 3. The used pump infusion line will be collected from the patient and analyzed for insulin binding to the plastic, as well as other possible effects that may determine its role in loss of glycemic control. 4. Comparison of some of the markers of coagulation, inflammation, protein glycation and oxidative stress 48, 72, and 96 hours after a pump infusion line change.

Type 1 Diabetes Mellitus

Type 1 diabetes mellitus Glycemic control Continuous subcutaneous insulin infusion Continuous glucose monitoring system

null

2

arm 1: Either insulin Aspart or insulin Lispro were randomized to be insulin 1. arm 2: Between insulin Aspart and insulin Lispro, the one that was not used as insulin 1 was then used as the second insulin for the second arm of the study.

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Either one of these insulins were given to the patient as the second insulin (depending on which was given as the first one, the other insulin was insulin 2). Patients used this insulin in the same dose as they did prior to entering the study. intervention 2: Patients were given either insulin Aspart or Lispro in test period 1. Then they were switched to the other insulin in test period 2.

intervention 1: Insulin Aspart intervention 2: Insulin Lispro

1

New Orleans | Louisiana | United States | -90.07507 | 29.95465

0

NCT00461331

[ 3 ]

8

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with brain metastases caused by kidney cancer or melanoma.

OBJECTIVES: Primary * Determine the efficacy of sunitinib malate, in terms of objective radiographic response of brain lesions, in patients with brain metastases secondary to renal cell carcinoma or melanoma. Secondary * Determine overall and progression-free survival. OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed periodically.

Kidney Cancer Melanoma (Skin) Metastatic Cancer

stage IV melanoma tumors metastatic to brain stage IV renal cell cancer recurrent melanoma recurrent renal cell cancer

null

1

arm 1: Patients will be treated with 50 mg daily for four out of every six weeks.

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: sunitinib malate

1

New York | New York | United States | -74.00597 | 40.71427

0

NCT00462982

[ 3 ]

124

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to examine the safety and efficacy of rebamipide by once daily intracolonial administration at 0 (placebo), 60, 150, or 300 mg for 6 weeks in patients with active ulcerative colitis, who are being treated with oral aminosalicylic acid (ASA).

null

Colitis, Ulcerative

Rebamipide Enema Ulcerative Colitis

null

4

arm 1: 0mg rebamipide arm 2: 60mg rebamipide arm 3: 150mg rebamipide arm 4: 300mg rebamipide

[ 2, 0, 0, 0 ]

1

[ 0 ]

intervention 1: 0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon

intervention 1: rebamipide

5

Chubu Region | N/A | Japan | N/A | N/A Chugoku Region | N/A | Japan | N/A | N/A Hokkaido Region | N/A | Japan | N/A | N/A Kinki Region | N/A | Japan | N/A | N/A Kyushu Region | N/A | Japan | N/A | N/A

0

NCT00463151

[ 3 ]

133

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

2MALE

true

The study will have two treatment groups, evaluating two Degarelix doses. First dose is the initial dose followed by a maintenance dose given every three months. The initial dose given to suppress the testosterone level and the three month maintenance dose to maintain the suppressed testosterone level over one year of treatment.

An Open-Label, Multi-Centre, Randomized Parallel-Group Dose-Finding Study, Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients with Prostrate Cancer Requiring Androgen Ablation Therapy.

Prostate Cancer

null

2

arm 1: Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months. arm 2: Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Experimental Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months. intervention 2: Experimental Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.

intervention 1: Degarelix intervention 2: Degarelix

29

0

NCT00468286

[ 5 ]

46

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

To compare the efficacy and safety in patients treated with travoprost versus dorzolamide/timolol maleate combination in patients with open-angle glaucoma or ocular hypertension

null

Open-angle Glaucoma Ocular Hypertension

null

2

arm 1: Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s) arm 2: treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s)

[ 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s) intervention 2: treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s) intervention 3: Travatan group: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)

intervention 1: Travatan intervention 2: Cosopt intervention 3: Placebo (Timolol Vehicle)

1

Coimbra | N/A | Portugal | -8.41955 | 40.20564

0

NCT00471068

[ 4 ]

50

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The study is designed to assess the efficacy and safety of multiple infusions of conivaptan in subjects with euvolemic or hypervolemic hyponatremia

null

Hyponatremia

hyponatremia hypervolemic euvolemic edematous conivaptan

null

3

arm 1: 20 mg conivaptan once a day arm 2: 20 mg conivaptan two times a day arm 3: None

[ 0, 0, 2 ]

2

[ 0, 0 ]

intervention 1: premix bag intervention 2: premix bag

intervention 1: Conivaptan intervention 2: Placebo

26

0

NCT00478192

[ 5 ]

22

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

4QUADRUPLE

true

0ALL

false

The goal of the study is to assess the role of cholinesterase inhibitors in affecting the driving ability of cognitively intact seniors using driving simulators. We hypothesize that the use of a cholinesterase inhibitor for two weeks will be associated with improvement in safe driving behavior on a simulated driving task.

Alzheimer's disease (AD) is the most common cause of dementia, and while it is known that AD poses substantial risks of motor vehicle collisions, many people in the earliest stages of AD continue to drive. Memory problems themselves are poor predictors of who is actually unsafe on the road, and various medications that are used to treat people with AD may impact on their driving abilities. Donepezil is a drug used to treat the memory problems associated with AD. While previous studies have shown that it slows the decline of activities of daily living (eg. shopping, banking, dressing) and may improve the ability of younger pilots to perform on computerized flight simulators, no studies have examined the impact of donepezil on driving abilities in older adults. The present investigation is a pilot study aiming to determine if donepezil helps healthy older drivers perform on driving simulators. Two Canadian academic centers have different driving simulators - one in Toronto and one in Thunder Bay. At each of these centers, ten healthy men aged 65 to 75 will be randomly assigned to receive either donepezil 5mg/day or identical placebo for two weeks. Using the driving simulator, we will assess various aspects of driving ability. These measures of driving performance will be compared between those who received the drug and those who received the placebo.

Mental Health Geriatrics

Donepezil Driving Cholinesterase Inhibitors Geriatric Psychiatry Psychopharmacology Aricept

null

2

arm 1: donepezil, capsule, 5mg daily once daily for 14 days arm 2: placebo (cornstarch), capsule, once daily for 14 days

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: donepezil intervention 2: Placebo (cornstarch)

2

0

NCT00482001

[ 3 ]

98

RANDOMIZED

PARALLEL

9OTHER

3TRIPLE

false

2MALE

false

The purpose of this study is to evaluate three dose levels of SKY0402 compared with 105 mg of bupivacaine HCl.

Effective postoperative pain control is a critical element in patient recovery, as the majority of patients may experience significant pain, particularly in the first few days following surgery. Appropriate postoperative pain management contributes to improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

Postoperative Pain

hernia unilateral postoperative analgesia

null

4

arm 1: Bupivacaine HCl given during hernia repair arm 2: SKY0402 low dose given during hernia repair arm 3: SKY0402 middle dose given during hernia repair arm 4: SKY0402 high dose given during hernia repair

[ 1, 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: Bupivacaine HCl given during hernia repair intervention 2: SKY0402 given during hernia repair

intervention 1: Bupivacaine HCl intervention 2: SKY0402

7

0

NCT00485433

[ 4 ]

796

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

A study to assess the efficacy and tolerability of ER (Extended Release) niacin/laropiprant versus placebo in Type 2 Diabetes Mellitus patients.

null

Diabetes Mellitus Type 2

null

2

arm 1: Arm 1: One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, advancing to ER niacin/laropiprant (2g) at Week 4 for the remainder of the study. arm 2: Arm 2: stable lipid-modifying regimen, adding Placebo ER niacin/laropiprant in week 4, for the duration of the study.

[ 5, 1 ]

2

[ 0, 0 ]

intervention 1: One tablet of ER niacin/laropiprant (1g); advancing to ER niacin/laropiprant (2g) at Week 4 for the remainder of the study 36 Weeks. intervention 2: ER niacin/laropiprant Placebo

intervention 1: ER niacin/laropiprant intervention 2: Comparator : placebo (unspecified)

0

null

0

NCT00485758

[ 5 ]

137

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

null

The purpose of this study is to investigate the effect on exercise tolerance, lung function and symptoms after treatment with Symbicort, Oxis or placebo in patients with severe chronic obstructive pulmonary disease.

null

Chronic Obstructive Pulmonary Disease

COPD

null

3

arm 1: Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily arm 2: Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily arm 3: Placebo, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily

[ 0, 0, 2 ]

3

[ 0, 0, 10 ]

intervention 1: Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms intervention 2: Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily intervention 3: Placebo, 1 inhalation twice daily

intervention 1: budesonide/formoterol Turbuhaler 320/9µg intervention 2: formoterol Turbuhaler 9µg intervention 3: Placebo

9

Berlin | N/A | Germany | 13.41053 | 52.52437 Erfurt | N/A | Germany | 11.03283 | 50.9787 Fulda | N/A | Germany | 9.67518 | 50.55162 Fürth | N/A | Germany | 10.98856 | 49.47593 Geesthacht | N/A | Germany | 10.3779 | 53.43575 Grobhansdorf | N/A | Germany | N/A | N/A Leipzig | N/A | Germany | 12.37129 | 51.33962 Neuruppin | N/A | Germany | 12.80311 | 52.92815 Basel | Canton of Basel-City | Switzerland | 7.57327 | 47.55839

0

NCT00489853

[ 3 ]

165

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

1FEMALE

false

A Multi-center study to determine effects of various doses of Macroflux Parathryroid Hormone (PTH) in women with osteoporosis

null

Osteoporosis

null

5

arm 1: Macroflux® placebo patch arm 2: Macroflux® 20 mcg patch arm 3: Macroflux® 30 mcg patch arm 4: Macroflux® 40 mcg patch arm 5: FORTEO® 20 mcg injection

[ 2, 0, 0, 0, 1 ]

2

[ 0, 0 ]

intervention 1: Macroflux® patch applied to the abdomen for 30 minutes daily intervention 2: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh

intervention 1: teriparatide intervention 2: teriparatide

0

null

0

NCT00489918

[ 4 ]

182

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

true

0ALL

true

The purpose of this study is to determine if the consumption of a yogurt drink containing a high dose of probiotics decreases absences, due to illnesses, in daycare centers for children between the ages of 1 and 3.

It is reported that more than half of all young children attend daycare centers in the United States. Absences due to illnesses are costly both on an individual and societal level; these absences are generally due to diarrhea or upper respiratory infections. In the U.S., children under five years of age experience 20-35 million episodes of diarrhea per year. These episodes lead to 2-3.5 million physician visits (which account for 10% of all visits by children), more than 200,000 hospitalizations (13% of hospital admissions in children under five years), and 325-425 deaths annually. In 1991, the outpatient costs of treating diarrhea in children under age three was calculated at 0.6-1 billion dollars per year. Respiratory illness is among the leading causes of death in children under five years of age. Approximately 200,000 deaths in the U.S. and 3.9 million deaths worldwide are attributed to respiratory illnesses. Respiratory illness is also the most frequent reason for physician consultation, with more than 40% of all pediatric outpatient visits related to respiratory illness. According to a recent study, 39% of children attending daycare experienced acute otitis media (ear infection) and 26% reported allergies. Most notably, 10% of children attending daycare were admitted to the hospital due to respiratory illnesses. We have chosen BB-12 as the probiotic for this study as it is one of the best characterized probiotics with a long safety record in children, a well-proven ability to colonize the human intestinal tract, and demonstrated efficacy for different pediatric conditions. Furthermore, BB-12 is a commercially available probiotic strain that has been used in a number of feeding and clinical trials. In fact, there is a new infant formula on the market, using the identical strain we are, in the first commercially available probiotic infant formula available in the United States. Not only has BB-12 been found to survive transit through the stomach, small intestine and colon, but also long-term consumption of BB-12 formula at levels as high as 1 billion CFU/g (240 g serving) have been found to be safe. Our overall goal is to demonstrate that a probiotic-containing yogurt beverage can be used successfully as a vehicle for delivering health-enhancing probiotics; more specifically to determine if a yogurt drink containing Bifidobacterium lactis BB-12 at a minimum 1010 colony forming units (CFU)/per serving can prevent daycare absences. The rationale for focusing on food as a vehicle for the transmission of probiotics is that it has the potential to benefit children more than using probiotics in a more medicinal manner, such as pills or capsules. By providing an intervention in the form of a yogurt drink, parents are given a more convenient and simple alternative to traditional probiotic supplements. As yogurt is known to be a nutrient dense food, a yogurt drink is likely to be more appealing to both children and their parents for long-term consumption than pharmaceutical-like preparations. Although compliance with most medicinal regimens is around 50%, by offering a more attractive formulation of high dose probiotics and collaborating with participants we believe compliance will exceed normal levels. Ultimately, by capitalizing on the widely accepted healthy image of yogurt and offering a simple, convenient source of probiotics, we believe this product has the potential to positively impact the health of children around the world.

Healthy

probiotic health bifidobacterium lactis BB-12

null

2

arm 1: Subjects were provided 4 fluid ounces (112 grams) administered orally per day of placebo drink. arm 2: Subjects were provided 4 fluid ounces (112 grams) administered orally per day of active drink.

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: The active drink is currently available commercially on campus at The Berkey Creamery at Penn State in State College, Pennsylvania. The active drink combined a commercial blend (YFL-702, Chr.) of the following active cultures, Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus. The active drink was also supplemented with the probiotic BB-12, acquired from Chr. Hansen (Milwaukee, Wisconsin). intervention 2: The placebo drink combined a commercial blend (YFL-702, Chr.) of the following active cultures, Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus.

intervention 1: Bifidobacterium lactis (BB-12) intervention 2: Placebo

1

Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511

0

NCT00492583

[ 5 ]

15

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

1SINGLE

true

0ALL

false

RATIONALE: Garlic supplements may alter the pharmacokinetics of oxycodone, thereby affecting its effectiveness as an opioid analgesic for the relief of moderate or severe pain. PURPOSE: This randomized phase 4 trial is studying how garlic supplements may change the pharmacokinetics of oxycodone and its analgesic and side effects in healthy volunteers.

OBJECTIVES: * To determine whether CYP3A (Cytochrome P450 3A) and/or P-glycoprotein mediated interactions exist between garlic supplements and oxycodone (a commonly used oral opioid analgesic) in healthy volunteers. OUTLINE: This is a single-blind, randomized, crossover study. Participants are randomized to 1 of 2 arms. Each arm entails two 30-day treatment periods, with a washout of at least 4 weeks in between. * Arm I: In Period 1, participants receive oral garlic powder twice daily on days 1-28 and oral oxycodone on day 28. In Period 2, participants receive oral placebo twice daily on days 1-28 and oral oxycodone on day 28. * Arm II: In Period 1, participants receive oral placebo twice daily on days 1-28 and oral oxycodone on days 28. In Period 2, participants receive oral garlic powder twice daily on days 1-28 and oral oxycodone on day 28. In both periods of each arm, participants receive a combination of oral midazolam and oral digoxin for CYP3A and P-glycoprotein phenotyping on day 29. Blood samples are collected periodically and analyzed by liquid chromatography-mass spectrometry (LC-MS). Blood and urine samples are collected after receiving oxycodone for pharmacokinetic characterization. Plasma concentrations of oxycodone and its metabolites are measured by LC-MS. Response to experimentally induced pain by the Cold Pressor Test (CPT) is assessed at baseline and periodically after oxycodone treatment. Subjective ratings of opioid side effects are assessed by validated questionnaires for somatic side effects and cognitive function impairments.

Healthy, No Evidence of Disease

null

2

arm 1: Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral garlic powder tablet twice daily on days 1-30, oral oxycodone on day 28, and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral placebo twice daily on days 1-30, oral oxycodone on day 28, and a combination of oral midazolam and digoxin on day 29. arm 2: Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral placebo twice daily on days 1-30, oral oxycodone on day 28, and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral garlic powder tablet twice daily on days 1-30, oral oxycodone on day 28, and a combination of oral midazolam and digoxin on day 29.

[ 5, 5 ]

2

[ 7, 0 ]

intervention 1: Each Garlicin tablet has a claimed allicin content of 3,200 microgram per tablet intervention 2: Single administration of three 5-mg oxycodone tablets or a 15-mg dose

intervention 1: garlic powder tablets intervention 2: oxycodone

1

Seattle | Washington | United States | -122.33207 | 47.60621

0

NCT00499460

[ 3 ]

41

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

0NONE

false

0ALL

true

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Amifostine may decrease the side effects caused by chemotherapy and radiation therapy. It is not yet known whether chemotherapy and radiation therapy are more effective with or without amifostine in treating head and neck cancer. PURPOSE: This randomized phase II trial is studying amifostine to see how well it works compared with standard care in reducing side effects in patients undergoing chemotherapy and radiation therapy for stage III or stage IV head and neck cancer.

OBJECTIVES: Primary * To compare the incidence and severity of acute and chronic swallowing dysfunction in stage III or IV head and neck cancer patients receiving concurrent chemoradiation with or without amifostine Secondary * To assess the relative incidence and severity of acute and chronic xerostomia in stage III or IV head and neck cancer patients receiving chemoradiation with or without amifostine. * To assess the relative incidence and severity of mucositis and mucositis-related inflammation in stage III or IV head and neck cancer patients receiving chemoradiation with or without amifostine. * To assess the effects of dysphagia, xerostomia, and mucositis-related inflammation on nutritional, physical, and functional status OUTLINE: Patients undergo intensity-modulated radiotherapy (IMRT) and concurrent chemotherapy comprising carboplatin and paclitaxel weekly. Patients are randomized to 1 of 2 treatment arms. * Arm I (standard of care): Patients are further divided into 1A or 1B. * Arm IA: Standard of care plus standardized nutrition therapy (SNT) * Arm IB: Standard of care plus standardized nutrition therapy plus low weight resistance training (LWRT). * Arm II (amifostine): Patients are further divided into 2A or 2B. * Arm IIA: Amifostine 500mg diluted in 2.9 ml injected 30-60 minutes prior to each radiation dose plus standardized nutrition therapy * Arm IIB: Amifostine 500mg diluted in 2.9 ml injected 30-60 minutes prior to each radiation dose plus standardized nutrition therapy plus low weight resistance training In all arms, patients undergo swallowing function, dietary, body composition, muscle, and physical and functional performance measurements at baseline and at 1, 3, and 6 months post-therapy. Quality of life, salivary production, fatigue, and symptoms (including swallowing/eating foods, appetite, weight loss/nutrition, pain, and speech/communication) are assessed at baseline and at 1, 3, and 6 months post-therapy. Anthropometric measurements are also performed at the above time points and at mid-therapy. Blood samples and buccal rinses are collected at baseline and at 1, 3, and 6 months post-therapy for biomarker studies and for proteomic and genomic analysis by liquid chromatography and tandem mass spectrometry. After completion of study treatment, patients are followed at 1, 3, and 6 months.

Dysphagia Head and Neck Cancer Mucositis Xerostomia

xerostomia mucositis dysphagia radiation toxicity chemotherapeutic agent toxicity stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx stage III verrucous carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage IV verrucous carcinoma of the larynx recurrent squamous cell carcinoma of the larynx recurrent verrucous carcinoma of the larynx stage III squamous cell carcinoma of the lip and oral cavity stage III verrucous carcinoma of the oral cavity stage IV squamous cell carcinoma of the lip and oral cavity stage IV verrucous carcinoma of the oral cavity recurrent squamous cell carcinoma of the lip and oral cavity recurrent verrucous carcinoma of the oral cavity stage III squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the nasopharynx stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the oropharynx salivary gland squamous cell carcinoma stage III salivary gland cancer stage IV salivary gland cancer recurrent salivary gland cancer

null

4

arm 1: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction. arm 2: Patients undergo SNT and low weight resistance training (LWRT). arm 3: Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA. arm 4: Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.

[ 1, 1, 0, 0 ]

3

[ 5, 0, 3 ]

intervention 1: Patients undergo low weight resistance training. intervention 2: Given subcutaneously intervention 3: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

intervention 1: exercise intervention intervention 2: amifostine trihydrate intervention 3: therapeutic dietary intervention

1

Nashville | Tennessee | United States | -86.78444 | 36.16589

0

NCT00503776

[ 4 ]

165

RANDOMIZED

CROSSOVER

2DIAGNOSTIC

1SINGLE

false

0ALL

false

This study is conducted to compare the contrast effect and safety of SH L562BB with ProHance, which has already been approved as a pharmaceutical product of similar indication.

null

Brain Metastases

MRI Brain Metastasis Gadolinium Imaging Diagnostic Agent

null

3

arm 1: Participants received first injection (intravenous \[i.v.\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw arm 2: Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min arm 3: Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Gadobutrol enhanced MRI (first injection of gadobutrol 0.1 mmol/kg bw, corresponding to a dose of 0.1 mmol/kg bw) intervention 2: Gadobutrol enhanced MRI (second injection of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw) intervention 3: ProHance enhanced MRI (two injections of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw)

intervention 1: Gadobutrol (Gadavist, Gadovist, BAY86-4875) intervention 2: Gadobutrol (Gadavist, Gadovist, BAY86-4875) intervention 3: ProHance

20

0

NCT00522951

[ 3 ]

6

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

null

false

1FEMALE

true

RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them before surgery may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving liposomal doxorubicin together with docetaxel before surgery and to see how well it works in treating women with locally advanced breast cancer that can be removed by surgery.

OBJECTIVES: Primary * To evaluate the rate of pathological complete response and clinical complete response in women with locally advanced breast cancer treated with pegylated doxorubicin hydrochloride liposome and docetaxel. Secondary * To assess the overall clinical local regional response in patients treated with this preoperative chemotherapy regimen. * To evaluate the number of patients who would have required a mastectomy upfront but who underwent breast conservation therapy instead after neoadjuvant chemotherapy. * To assess the safety, particularly with regard to neutropenia and cardiac toxicity, of pegylated doxorubicin hydrochloride liposome and docetaxel. OUTLINE: This is a multicenter study. Patients receive pegylated doxorubicin hydrochloride liposome IV over 90 minutes and docetaxel IV over 90 minutes on day 1. Patients receive pegylated filgrastim subcutaneously on days 2 or 3 post-chemotherapy in courses 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Within 8 weeks after completion of chemotherapy, patients undergo a lumpectomy or mastectomy to remove the tumor. Some patients may receive additional therapy after surgery, including hormonal therapy, chemotherapy, or radiotherapy. After completion of study therapy, patients are followed periodically for up to 5 years.

Breast Cancer

stage IIIA breast cancer stage IIIB breast cancer

null

0

null

4

[ 0, 0, 3, 3 ]

intervention 1: None intervention 2: None intervention 3: None intervention 4: None

intervention 1: docetaxel intervention 2: pegylated liposomal doxorubicin hydrochloride intervention 3: conventional surgery intervention 4: neoadjuvant therapy

1

Buffalo | New York | United States | -78.87837 | 42.88645

0

NCT00524459

[ 4 ]

234

NON_RANDOMIZED

SINGLE_GROUP

2DIAGNOSTIC

0NONE

false

0ALL

true

Participants who had been diagnosed or suspected by doctors to have focal liver lesions that need further evaluation in order to make an accurate diagnosis. Participants would need to have an enhanced magnetic resonance imaging (MRI) scan so that doctors could have further information about the number and characteristics of the focal liver lesions. Participants were invited to take part in this clinical study. The purpose of this study was to evaluate Primovist, which is a liver-specific MRI contrast medium, on the efficacy of lesion detection and characterization, and tolerability in Chinese patients with known or suspected focal liver lesions. Primovist, the investigational drug in this study, is a liver-specific MRI contrast medium developed by Bayer Schering Pharma AG. Its active substance is Gd-EOB-DTPA. Primovist was first approved in 2004 in Sweden followed by an approval in the European community, in Switzerland and Australia in the same year. Procedures: Before entry into the study and after entry of the study a physical examination was conducted, blood pressure and heart rate were measured, blood and urine samples were taken. Current medications and medical conditions (including suspected pregnancy) and medical and surgical history were elicited by doctors. After entry into the study, participants were scheduled to have an MRI examination, which lasted about 25-35 minutes. During the MRI examination, an initial MRI scan without contrast was acquired which followed by another MRI series after the intravenous administration of Primovist. The following day participants were asked to return to the hospital for a follow-up safety evaluation. Possible Benefit Participants were scheduled to receive an enhanced magnetic resonance imaging scan. Clinical studies indicated that Primovist increased the efficacy of detection and characterization of focal liver lesions by providing better contrast between the focal liver lesions and surrounding normal tissue. Primovist were shown to provide additional information regarding existence, number and characterization (lesion or non-lesion, malignant or benign) of these abnormalities. Based on the experience with patients given Primovist, some adverse reactions were observed. Most of undesirable effects were transient and of mild to moderate intensity. The most commonly noted adverse events (AEs) in subjects receiving Primovist for MRI were nausea and headache with an incidence of 1.1%. Other AEs that occurred in 0.5% of the subject population were feeling hot (0.8%), back pain (0.6%) and dizziness (0.5%). All other AEs occurred in less than 0.5% of the patients, e.g. anxiety; coughing; eye disorder; fever; flatulence; generalized spasm; hypertension; injection site symptoms including edema, inflammation, and reaction; lightheadedness; parosmia; postural hypotension; taste perversion, motoric unrest; acute respiratory distress; fatigue; malaise; vomiting; palpitations, erythema, chest pain and back pain. Coldness, warmth or pain at the injection site, injection site reaction, and injection site accumulation of fluid were rare. In very rare cases strong allergy-like reactions ranging to shock may occur. Post-marketing tachycardia and restlessness have been reported. As in the case of other investigational drugs, there may also be unforeseen side effects. Additional information concerning all Gadolinium- based contrast agents Primovist contains the rare earth metal gadolinium as active ingredient. There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents (especially Omniscan) in patients with severe renal impairment. NSF is a systemic disease characterised by formation of connective tissue in the skin, which becomes thickened and hard, sometimes leading to contractures and joint immobility. The clinical course is usually progressive and currently no treatment is available. To date NSF has only been reported in association with some Gd-containing contrast agents, but the role of these contrast agents in the overall pathogenesis of the disease is still not completely understood. No reports of patients with NSF after administration of Primovist® are known. The risk to trigger NSF in risk patients with severe renal impairment is considered to be low for Primovist® due to the low dose given and the additional excretion via feces. Furthermore the participation of patients with severe renal impairment are excluded from this study. In case the participants were suffering from renal insufficiency, they were told to tell their doctors prior to application of the contrast agent. In case the participants experienced any new alterations of the skin following the administration of the contrast agent, they were told to contact their doctors as soon as possible after they had recognized these symptoms.

Adult Chinese patients with known focal or suspected liver lesions, referred for magnetic resonance imaging (MRI) for further diagnostic work-up, who have undergone or are scheduled to undergo a defined SOR procedure, within one month before or after the study MRI. The data for the Secondary Outcome Measure "Lesion size and location" has been documented but not analyzed. The data for the Secondary Outcome Measure "Safety" are reflected in the Adverse Event section.

Known or Suspected Focal Liver Lesions

Primovist Chinese patients Liver MRI

null

1

arm 1: Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient

[ 0 ]

1

[ 0 ]

intervention 1: Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient

intervention 1: Gadoxetic Acid Disodium (Primovist, BAY86-4873)

6

0

NCT00526188

[ 5 ]

54

RANDOMIZED

SINGLE_GROUP

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to compare the comfort of Travatan Z in one eye and Xalatan in the opposite eye in patients with primary open-angle glaucoma or ocular hypertension.

null

Open-Angle Glaucoma Ocular Hypertension

Comfort

null

2

arm 1: Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control. One drop, single dose. The eye, and the order in which the first test medicine was instilled (either travoprost or latanoprost), was randomly assigned. arm 2: Latanoprost assigned to one eye, with travoprost assigned to the fellow eye for intra-individual control. One drop, single dose. The eye, and the order in which the first test medicine was instilled (either travoprost or latanoprost), was randomly assigned.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as travoprost. intervention 2: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as latanoprost.

intervention 1: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) intervention 2: Latanoprost ophthalmic solution 0.005% (XALATAN®)

0

null

0

NCT00527592

[ 4 ]

805

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

This study was designed to assess the safety of indacaterol (300 µg and 600 µg (2 x 300 μg capsules) once daily \[od\]), compared with salmeterol (50 μg twice a day \[b.i.d.\]), over 26 weeks, in patients with moderate to severe persistent asthma.

null

Asthma

asthma QAB149 indacaterol

null

3

arm 1: Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 07:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 2: Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 07:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 3: Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 07:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

[ 0, 0, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Indacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI). intervention 2: Salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device. intervention 3: Placebo to indacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI). intervention 4: Placebo to salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device.

intervention 1: Indacaterol 300 μg intervention 2: Salmeterol 50 μg intervention 3: Placebo to indacaterol intervention 4: Placebo to salmeterol

126

0

NCT00529529

[ 5 ]

586

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

null

The study will compare the safety and efficacy of Bimatoprost and Latanoprost in patients with glaucoma or ocular hypertension

null

Ocular Hypertension Glaucoma

null

2

arm 1: bimatoprost 0.03% eye drops arm 2: latanoprost 0.005% eye drops

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of bimatoprost 0.03% 1 drop every evening for 12 weeks intervention 2: Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of latanoprost 0.005% 1 drop every evening for 12 weeks

intervention 1: bimatoprost 0.03% eye drops intervention 2: latanoprost 0.005% eye drops

1

Newport Beach | California | United States | -117.92895 | 33.61891

0

NCT00541242

[ 5 ]

442

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

false

0ALL

false

This study is to assess the effects with two different inhaled respiratory medications with regards to improvement of lung function, symptoms and morning activities.

null

Chronic Obstructive Pulmonary Disease (COPD)

COPD Symbicort Seretide

null

2

arm 1: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg arm 2: Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg intervention 2: Seretide Diskus (salmeterol/fluticasone) 50/500 μg

59

0

NCT00542880

[ 0 ]

20

RANDOMIZED

PARALLEL

7BASIC_SCIENCE

4QUADRUPLE

false

0ALL

false

The purpose of this study is to test the effects of sleep and eszopiclone, a drug that helps people sleep, on how the body processes glucose (sugar). Eszopiclone is approved by the U.S. Food and Drug Administration (FDA) for sale for the treatment of insomnia. It is marketed in the United States as LUNESTA. Main Hypothesis: Primary insomnia is associated with impairments of glucose metabolism that can be reversed by two months of eszopiclone for the primary insomnia

Insomnia is the most common sleep disorder, affecting nearly one-third of all adults in any given year, and chronically affecting 10-15% of the adult population. Reduced sleep time, independent of insomnia, has been associated with a variety of deleterious long term effects, including an increased risk of incident myocardial infarction and symptomatic diabetes. Chronic partial sleep loss or insomnia may impair glucose metabolism in the short term and are associated with the development of diabetes in the long term. Although the extent of sleep loss is more acute in the laboratory-based 'sleep debt' studies of healthy volunteers, chronic primary insomnia patients exhibit 'hyperarousal' (hypercortisolemia in the afternoon and evening, accelerated metabolism) similar to that seen with acute sleep deprivation. In addition, degradations of sleep quantity and quality in primary insomnia have been attributed to cognitive and somatic hyperarousal in the sleep setting. study examines and quantifies in adult men and women the link between primary insomnia and impaired glucose tolerance. This study examines the extent which adequate treatment of primary insomnia reverses impairments of glucose metabolism. If abnormalities of glucose metabolism are reversible, this study will demonstrate the importance of treatment of chronic primary insomnia.

Primary Insomnia

sleep metabolism insulin glucose actigraphy diary volumetry GABA

null

2

arm 1: active medication (eszopiclone 3mg tablet) by mouth nightly 30 min before bed arm 2: identical placebo tablet by mouth nightly 30 min before bed

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 3mg tablet, by mouth nightly 30 min before bed, for two months intervention 2: inactive placebo tablet, by mouth nightly 30 minutes before bed, for two months

intervention 1: eszopiclone intervention 2: placebo

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00555750

[ 2, 3 ]

120

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

We evaluated whether voriconazole is a superior treatment to natamycin for filamentous fungal keratitis in a randomized, masked, controlled trial. This is a therapeutic exploratory study to investigate the safety and feasibility of conducting a larger study and to generate preliminary data.

Fungal ulcers tend to have very poor outcomes with the most common treatments, amphotericin B and natamycin. There has been only a single randomized trial of anti-fungal therapy for fungal ulcers and no new medications have been approved by the FDA since the 1960s. There are studies that indicate that the newer triazoles, such as voriconazole, are more effective in vitro against filamentous fungi such as Aspergillus spp., a common cause of fungal keratitis1-3. Despite a number of case reports and in vitro studies, there has been no systematic attempt to determine whether it is more or less effective clinically than natamycin, the only commercially available FDA-approved agent. There is little data available for physicians to make an informed, evidence-based decision on choice of antifungal. We evaluated whether voriconazole is a superior treatment to natamycin for filamentous fungal keratitis in a randomized, masked, controlled trial. This is a therapeutic exploratory study to investigate the safety and feasibility of conducting a larger study and to generate preliminary data. The primary outcome is visual acuity at 3 months from enrollment. A subset of patients will be followed at 4 years from enrollment.

Fungal Keratitis

Keratitis Eye Infection, Fungal Fungal Eye Infection Ocular Infection, Fungal Fungal Keratitis Mycotic Infections, Ocular Voriconazole Natamycin

null

4

arm 1: Topical voriconazole with corneal de-epithelialization arm 2: Topical voriconazole without corneal de-epithelialization arm 3: Topical natamycin with corneal de-epithelialization arm 4: Topical natamycin without corneal de-epithelialization

[ 1, 1, 1, 1 ]

3

[ 0, 0, 3 ]

intervention 1: One drop of medication will be given every one hour while awake for one week. For another 2 weeks, one drop of medication should be given every 2 hours while awake intervention 2: Voriconazole (VFEND® I.V., Pfizer, New York, NY) will be prepared as a 1% solution. One drop of medication should be given every one hour while awake for one week. For another 2 weeks, one drop of medication should be given every 2 hours while awake intervention 3: Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications.

intervention 1: Natamycin 5% intervention 2: Voriconazole intervention 3: Corneal de-epithelialization

2

0

NCT00557362

[ 3 ]

21

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

false

An H3 receptor antagonist should reduce the congestion associated with allergic rhinitis. A nasal allergen challenge will be given to patients to induce rhinitis symptoms and acoustic rhinometry will be used to measure the congestion.

null

Allergic Rhinitis

null

4

arm 1: None arm 2: None arm 3: None arm 4: None

[ 2, 1, 1, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: A single oral dose of Placebo is dosed during the study in order to ascertain the effect of placebo on measures and in order to maintain the blind of the other drugs. intervention 2: A single oral dose of Allegra is dosed to subjects in combination with PF-03654746. intervention 3: A single oral dose of Allegra-D is dosed to subjects as an active comparator. intervention 4: A single oral dose of PF-03654746 is the investigational drug being studied.

intervention 1: Placebo intervention 2: Allegra intervention 3: Allegra-D intervention 4: PF-03654746

1

Omaha | Nebraska | United States | -95.94043 | 41.25626

0

NCT00562120

[ 0 ]

35

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

A 6-week outpatient, double-blind, placebo-controlled, add-on trial to investigate the effects of levetiracetam on depressive symptoms in bipolar depressed patients.

null

Bipolar Depression

Keppra Levetiracetam Anticonvulsant Depression Bipolar Disorder Affective Disorders Mood Disorders Double Blind Acute Antidepressant Effects

null

2

arm 1: None arm 2: None

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Flexible dose up to 2500mg per day, for 6 weeks. intervention 2: Flexible dose up to 2500mg per day, for 6 weeks.

intervention 1: Levetiracetam intervention 2: Placebo

1

New Haven | Connecticut | United States | -72.92816 | 41.30815

0

NCT00566150

[ 2 ]

153

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

1SINGLE

true

0ALL

false

Pharmacokinetics, Bioavailability, Safety and Immunogenicity of Single Doses of Belatacept Administered Subcutaneously to Healthy Subjects

null

Transplantation

null

8

arm 1: Belatacept 50 mg subcutaneous (SC) injection arm 2: Belatacept 100 mg SC injection arm 3: Belatacept 125 mg SC injection arm 4: 2 SC injections of 75 mg Belatacept arm 5: 2 SC injections of 100 mg Belatacept arm 6: 2 SC injections of 125 mg Belatacept arm 7: 125 mg Belatacept intravenous (IV) injection arm 8: SC injection of placebo solution

[ 1, 1, 1, 1, 1, 1, 1, 2 ]

2

[ 0, 0 ]

intervention 1: single dose, 116 days intervention 2: Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)

intervention 1: belatacept intervention 2: Placebo

1

Austin | Texas | United States | -97.74306 | 30.26715

0

NCT00569803

[ 0 ]

12

NA

SINGLE_GROUP

7BASIC_SCIENCE

0NONE

true

0ALL

false

The main purpose of this protocol is to study the effect of an HIV medication, Kaletra (lopinavir/ritonavir), on buprenorphine in non-HIV infected people who have been receiving the same dose of buprenorphine for at least 3 weeks. Study Hypothesis: Kaletra (lopinavir/ritonavir) will increase buprenorphine plasma levels without any significant clinical effect on the subject or need for dose adjustment.

Buprenorphine (BUP) is a partial opiate agonist dosed sublingually for both supervised opiate withdrawal and maintenance for opiate dependence. Until recently, methadone has been the mainstay of pharmacological treatment for opiate-dependent persons with HIV infection. In October, 2002, buprenorphine (BUP) was approved for opiate maintenance and can be prescribed by primary care physicians. It is anticipated that many HIV specialists will begin prescribing BUP for their HIV+ patients on ARVs with a history of opiate dependence. This will continue to increase in importance as a method of treatment for this patient population for the following reasons: 1) Multiple federal programs are working to encourage the use of BUP in primary care, especially HIV primary care, settings. The goal of these programs is to increase opiate treatment slots across the country. 2) Many methadone programs have wait lists or regulations (e.g., daily dosing) which may not be possible for some patients. BUP, with its flexibility in dosing and ease of use, will increasingly become a first line in the treatment of opioid dependence. Buprenorphine administration carries the theoretical risk of drug interactions with respect to both inhibition or induction of BUP as well as similar effects on medications co-administered with BUP. Interactions may lead to under or overdosing of buprenorphine and/or antiretroviral agents with resultant adverse clinical consequences. Buprenorphine's effects on Kaletra and other ARVs cannot be predicted based on prior experience with methadone because BUP metabolism appears to differ from methadone in terms of its substrate and effects on cytochrome P450. Limited information currently exists regarding interactions between HIV therapeutic agents and buprenorphine. Similar to buprenorphine, the protease inhibitors, and NNRTIs are metabolized primarily via the CYP3A4 isozyme of the cytochrome P450 system. The extent to which methadone levels decrease with induction of cytochrome P450 isoenzymes has been correlated clinically with severity of symptoms of withdrawal. Similar studies with buprenorphine are not yet available. Interactions between buprenorphine and antiretroviral agents may complicate the management of HIV disease when these medications are coadministered. In a small sample study, there was no increase in buprenorphine dosing required when co-administered with Sustiva. However, in one study with liver microsomes, ritonavir inhibited the metabolism of buprenorphine at CYP 3A4, but the clinical significance of this inhibition could not be demonstrated. It is well known that in vitro and in vivo studies do not fully correlate with one another and empiric pharmacologic interaction studies in human subjects are necessary. The treatment of opiate addiction is a complicated and labor intensive practice. This study will require the use of Kaletra alone in HIV negative opiate dependent patients. This is critical to ascertain the reality of both objective data (levels of buprenorphine and lopinavir), as well as valid subjective symptoms of opiate withdrawal (symptoms that addicts have previously experienced and can more readily communicate).

HIV Infections

HIV Pharmacokinetics Buprenorphine Kaletra HIV Seronegativity

null

1

arm 1: HIV negative subjects currently enrolled in a long-term buprenorphine maintenance therapy program for at least 3 months who have been on stable dose of buprenorphine for at least 3 weeks will be admitted to the General Clinical Research Center (GCRC) for pharmacokinetic (PK) blood draws at intervals over a 24-hour period. Subjects will then receive Kaletra and buprenorphine coadministered for 14 days. Subjects will be admitted to the GCRC for a second PK sampling day.

[ 0 ]

3

[ 0, 0, 10 ]

intervention 1: 4 tablets, once a day (800 mg/dose) on Days 2 through 14 of this study intervention 2: Buprenorphine will be obtained through prescription at the subject's drug treatment program. intervention 3: Physical examinations, vital sign measurements, 12-lead electrocardiogram (ECG), clinical laboratory evaluations (blood chemistry and blood counts), PK blood draws.

intervention 1: Kaletra (lopinavir/ritonavir) intervention 2: buprenorphine intervention 3: Clinical evaluations/Blood draws

1

New Haven | Connecticut | United States | -72.92816 | 41.30815

0

NCT00571961

[ 5 ]

36

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

0ALL

false

This study is being done to examine the influence of Tiotropium (good or bad) on heart function at rest and during exercise in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Patients who develop chronic obstructive pulmonary disease (COPD) have a loss of elastic recoil of the lungs, have remodeling in the airways and pulmonary vasculature, develop inhomogeneities in ventilation (VA) and perfusion (Qc) and gradually lose their reserves for producing expiratory flow, particularly over the mid to lower lung volumes. As a result, they develop air trapping, have slowed expiration, and gradually hyperinflate with a large residual volume, an exaggerated total lung capacity, reduced vital capacity, and markedly reduced maximal expiratory flows. With exercise, patients with moderate to severe COPD are further challenged by the need for increased ventilation. Expiring against the narrowed airways results in breathing at higher and higher lung volumes until the elastic load on inspiration increases the work and cost of breathing to the point where exercise discontinues. It remains controversial if this scenario leads to primarily dyspnea from the weak and heavily recruited inspiratory muscles, inspiratory muscle fatigue or if a primary limitation might be related to the relatively large cardiac output required for the respiratory muscles, at the expense of the locomotor muscles, resulting in leg fatigue. The expiratory load also increases intrathoracic pressure and reduces the gradient for venous return, thus having the potential to reduce cardiac output. Pulmonary hypertension develops and may influence blood flow to the left side of the heart further inhibiting cardiac output. The ineffective inspiratory pressure generation by the diaphragm may also reduce the typical benefits of the respiratory muscle pump on venous return and the marked hyperinflation may influence left ventricular filling due to competition for intrathoracic space. Thus, although COPD primarily influences the respiratory system, we believe it has profound effects on cardiac function, and during exercise this may play a particular limitation. Use of a long-acting anticholinergic agent such as Tiotropium partially reverses airway obstruction (expiratory load) and hyperinflation, both potentially improving cardiovascular function. The focus of this research will be to determine influence of Tiotropium on cardiac parameters measured both at rest and during exercise. The focus of this study was to determine the influence of Tiotropium (Spiriva) on cardiac parameters measured both at rest and during exercise. More specifically, we first examined cardiac function in a group of COPD patients and healthy age and gender matched controls. Our hypothesis was that at rest cardiac function would be similar between groups; however, with light and heavier exercise, there would be evidence for a blunted stroke volume and perhaps cardiac output in the COPD patients. Second, we compared in a placebo-controlled double blinded manner cardiac function with and without chronic use of tiotropium in age, gender, and disease matched COPD patients. Our hypothesis was that in the Tiotropium (Spiriva) group at a matched workload, the reduced obstruction would allow for improved cardiac function, specifically an increase in stroke volume and reduction in heart rate. The interactions in this population between metabolic demand, fitness, lung mechanics, and cardiovascular function are complicated and thus studies were pursued at matched workloads and heart rate as well as with heavier exercise in an attempt to discriminate a primary influence of altered obstruction on cardiovascular function. The participants will be asked to come to the Cardiopulmonary Research Laboratory on 4 occasions (separate visits) for exercise testing (typically over the course of 2 to 4 weeks). Each session will take approximately 1-4 hours to complete and in the COPD population, visits will be repeated after receiving placebo or Tiotropium for 4 weeks. All of the exercise testing will be performed on an exercise bicycle either in the upright or semi-supine (recumbent) position and the participant will wear a SCUBA-type mouthpiece and a nose clip to analyze expired air. In addition, an EKG will be used to monitor heart rate and rhythm. Visit 1 (Screening Visit): During the first visit, participants will have a brief exam by a pulmonary physician. The exam will include a complete blood count (CBC) to rule out anemia, baseline spirometry to assess lung volumes and flow rates to meet entry criteria, and in women of childbearing potential a pregnancy test. They will also be taken off theophylline and inhaled anticholinergics, but allowed to continue long acting inhaled beta agonists (LABA) or short acting beta agonist (SABA) for a rescue medication. Subjects on long acting inhaled beta agonists will be asked to discontinue this medication temporarily, 48 hr. prior to each study visit, but restarted upon completion of the visit. Visit 2: A minimum of 48 hours after the first visit, participants will return for complete measures of lung volumes, flow rates, and diffusing capacity of the lung for carbon monoxide (DLCO), a baseline echocardiogram and a maximal exercise test on a cycle ergometer. Before the exercise begins, participants will have one or two small balloon(s) (2 inches long, deflated) attached to a small plastic tube (the width of a pencil tip) inserted through the nasal cavity and into the esophagus. This is done to measure respiratory muscle work. Participants will receive a numbing gel (2% lidocaine) to numb the nasal passage and upper esophagus prior to insertion of the balloon(s). During the insertion of the esophageal balloons, participants will also be asked to swallow water to minimize gagging and assure correct balloon placement in the esophagus. Participants will also be asked to breathe a mixture of gases containing acetylene (0.6%), dimethyl ether (1.8%), oxygen (21%, same as room air), helium (9%) and nitrogen (69.4%). The mixture of gases will be inhaled at various time points over the course of the exercise session for 8 to 10 breaths at a time. This is done to non-invasively measure cardiac output. Visit 3: Visit 3 will involve steady-state semi-recumbent cycling exercise at two steady-state exercise intensities; 40 percent of peak work and (after a brief rest) an intensity eliciting a heart rate of 110 beats per minute (to standardize diastolic duration). Before the exercise begins, participants will have one or two small balloon(s) (2 inches long, deflated) attached to a small plastic tube (the width of a pencil tip) inserted through the nasal cavity and into the esophagus. This is done to measure respiratory muscles at work. Participants will receive a numbing gel (2% lidocaine) to numb the nasal passage and upper esophagus prior to insertion of the balloon(s). During the insertion of the esophageal balloons, participants will also be asked to swallow water to minimize gagging and assure correct balloon placement in the esophagus. Participants will also be asked to breathe a mixture of gases containing acetylene (0.6%), dimethyl ether (1.8%), oxygen (21%, same as room air), helium (9%) and nitrogen (69.4%). The mixture of gases will be inhaled at various time points over the course of the exercise session for 8 to 10 breaths at a time. This is done to non-invasively measure cardiac output. Also during the session, a sonographer will use ultrasound to measure cardiac pressures and volumes. Visit 4: Visit 4 will involve steady-state exercise at 70% of peak work. Before the exercise begins, participants will have one or two small balloon(s) (2 inches long, deflated) attached to a small plastic tube (the width of a pencil tip) inserted through the nasal cavity and into the esophagus. This is done to measure respiratory muscles at work. Participants will receive a numbing gel (2% lidocaine) to numb the nasal passage and upper esophagus prior to insertion of the balloon(s). During the insertion of the esophageal balloons, participants will also be asked to swallow water to minimize gagging and assure correct balloon placement in the esophagus. Participants will also be asked to breathe a mixture of gases containing acetylene (0.6%), dimethyl ether (1.8%)oxygen (21%, same as room air), helium (9%) and nitrogen (69.4%). The mixture of gases will be inhaled at various time points over the course of the exercise session for 8 to 10 breaths at a time. This is done to non-invasively measure cardiac output. Upon completion of these baseline visits, the COPD patients will be randomly assigned to a standard dose of Tiotropium once-daily (18 µg) or placebo for 4 weeks (or until study completion as visits 2-4 may require 1-2 wks to complete). Patients otherwise will receive usual care, except (as noted) for discontinuing other anticholinergic bronchodilators and theophylline. They will also discontinue long acting beta agonists for 48 hours prior to performing each of the designated visits. At the end of this intervention period, the procedures outlined in Visits 2-4 will be repeated (on the COPD patients only). All post intervention visits will be timed so that the primary measures will be made 1.5 to 2 hrs post dose of Tiotropium.

Chronic Obstructive Pulmonary Disease COPD

COPD Tiotropium Spiriva

null

3

arm 1: Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder. arm 2: Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose. arm 3: Healthy age and gender matched controls were recruited for comparing cardiovascular responses to participants with chronic obstructive pulmonary disease prior to the intervention.

[ 0, 2, 4 ]

2

[ 0, 0 ]

intervention 1: Participants received once daily Spiriva capsules for oral inhalation: 18 mcg tiotropium powder, for use with HandiHaler device. intervention 2: Participants randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose, using the HandiHaler device.

intervention 1: Tiotropium intervention 2: Placebo

1

Rochester | Minnesota | United States | -92.4699 | 44.02163

0

NCT00578968

[ 0 ]

12

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to see if changing from one pain medication like morphine or oxycodone to another pain medication, oxymorphone (OPANA®), will be helpful to patients. This study will examine if the switching from one pain medication to another can be done over a 24 hour period. Oxymorphone, the drug being studied, is an FDA approved drug for treatment of severe pain.

null

Pain

Sciatica Diabetic Neuropathies Complex Regional Pain Syndromes Low Back Pain Neck Pain Headache Back Pain Arthritis Brachial Plexus Injury (stinger/burner) Chronic Pain Contractures Diabetes Fibromyalgia Foot Pain Fracture Hip Herpes Zoster (shingles) Migraine Neuropathic Pain Osteoarthritis Osteoporosis Rheumatoid Arthritis Scoliosis Nerve pain Opana Opioid Opioid Rotation Oxymorphone Morphine neuropathic oxycodone

null

1

arm 1: participants switched to oxymorphone extended release (ER) via both oral and intravenous patient-controlled analgesia (IV-PCA) oxymorphone. After 24 hours, participants were discharged with oral oxymorphone ER and oxymorphone immediate release (IR) as needed

[ 0 ]

1

[ 0 ]

intervention 1: IV PO

intervention 1: Oxymorphone

1

New York | New York | United States | -74.00597 | 40.71427

0

NCT00580294

[ 0 ]

13

RANDOMIZED

CROSSOVER

9OTHER

0NONE

true

0ALL

true

The study is a prospective open label study to examine the effects of oral and intravenous fat load on blood pressure, endothelial function, sympathetic activity, and oxidative stress in obese healthy subjects. Subjects will receive either 8-hour of intravenous or oral fat loads in either low or high doses or normal saline in random order. Blood samples are drawn and vitals are measured before and after the infusions. Endothelial function and plasma glucose and lipid levels are measured to study the effects.

Insulin resistance has been implicated as the central mechanism in the development of several cardiovascular risk factors including hypertension, diabetes, lipid disorders, and coagulation disorders. Recent evidence suggests that increased levels of a circulation fat (free fatty acids or FFAs) are a leading candidate causing insulin resistance. Our preliminary studies in indicate that, in addition to insulin resistance, the infusion of Intralipid and heparin to increase FFAs resulted in a significant rise in systolic and diastolic blood pressure, impaired endothelial (vascular) function, and increased inflammatory markers in obese African Americans with and without diabetes. The effects of FFA on insulin action are well established; however, the blood pressure and vascular effects of FFAs infusion in obese subjects have not been fully investigated. We hypothesize that observed changes in blood pressure are the result of acute endothelial dysfunction, and/or increased activation of the autonomic nervous system. No previous studies have attempted to determine a dose response effect of increasing FFA on blood pressure. In addition, it is not know if increased FFAs by repeated oral fat load results in similar blood pressure than intravenous lipid infusion. Accordingly, we propose: 1) a systematic evaluation of the effects of increasing FFA levels on blood pressure and endothelial (vascular) function, and 2) determine the effects of comparable increases in FFA concentration via intravenous infusion of Intralipid or by repeated oral fat load on blood pressure, insulin resistance and endothelial dysfunction in obese subjects. A group of obese normotensive subjects will be admitted to the Grady Clinical Research Center or to the Outpatient Research Unit in the Grady Diabetes Clinic on five occasions. In four of these admissions, research subjects will receive an 8-hour intravenous infusion, in random order, of increasing Intralipid concentration (10 ml, 20 ml, 40 ml per hour) or normal saline (40 ml per hour). During the final admission, research subjects will receive an oral liquid fat diet every 2 hours for 8-hours. The effect of increased FFAs on blood pressure and endothelial (vascular) function via intravenous infusion and via oral fat load therapy will be assessed.

Endothelial Dysfunction Hypertension

hypertension metabolic syndrome vascular reactivity Elevated blood pressure lipid toxicity

null

5

arm 1: Intralipid 20% IV infusion at 20cc/hour arm 2: Intralipid 20% IV infusion at 40cc/hour arm 3: Normal Saline continuous IV infusion at 40cc/hour for 8 hours arm 4: 32-gram oral fat load once arm 5: 64-gram oral fat load once

[ 1, 1, 2, 1, 1 ]

5

[ 0, 0, 0, 7, 7 ]

intervention 1: In this arm subjects received Intralipid 20% Intravenous IV continuous infusion at 20cc/hour for 8 hours. The 20% intralipid solution is a long-chain triglyceride emulsion composed of 50% polyunsaturated fatty acids, 26% monounsaturated fatty acids, and 19% saturated fatty acids. During the intralipid infusion studies, subjects remained fasting intervention 2: In this arm subjects received Intralipid 20% IV continuous infusion at 40cc/hour for 8 hours. In this arm subjects will receive Intralipid 20% Intravenous IV continuous infusion at 20cc/hour for 8 hours. The 20% intralipid solution is a long-chain triglyceride emulsion composed of 50% polyunsaturated fatty acids, 26% monounsaturated fatty acids, and 19% saturated fatty acids. During the intralipid infusion studies, subjects remained fasting. intervention 3: In this arm subjects received 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours. intervention 4: In this arm subjects received oral liquid fat load prepared by the General Clinical Research Center (GCRC) at baseline and every 2 hours for 6 hours. Participants received fat with Free Fatty Acids (FFA) composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h. intervention 5: In this arm subjects received 60-gram oral fat load intake at baseline and every 2 hours for 6 hours prepared by the General Clinical Research Center (GCRC). Participants received fat with Free Fatty Acids (FFA) composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.

intervention 1: Intralipid 20% @ 20cc/hour intervention 2: Intralipid 20%@ 40cc/hour intervention 3: Normal Saline intervention 4: 32-gram oral fat load intervention 5: 64-gram oral fat load

1

Atlanta | Georgia | United States | -84.38798 | 33.749

0

NCT00589888

[ 5 ]

74

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

The study is a multicenter, randomized controlled trial to compare the safety and efficacy of insulin analogs and human insulins both during acute intravenous treatment and during the transition to subcutaneous insulin in patients with diabetic ketoacidosis (DKA).

Diabetic ketoacidosis (DKA) is the most serious emergency in patients with diabetes. With an estimated 100,000 admissions per year in the United States, DKA is also the leading cause of death in children with type 1 diabetes, and accounts for a significant proportion of admissions in adult patients with type 1 and type 2 diabetes. The mainstay in the treatment of DKA involves the continuous intravenous (IV) infusion of regular insulin or the frequent subcutaneous (SC) injections of regular or rapid-acting insulin analogs. Multiple studies have reported successful protocols for insulin administration during the acute management of DKA, but they have failed to address the transition phase from IV to SC maintenance insulin regimen. The American Diabetes Association (ADA) position statement recommends the use of split-mixed insulin combination of regular and intermediate-acting insulin (NPH). This regimen, however, are associated with a high rate of hyperglycemia shortly after discontinuation of IV insulin and a risk of hypoglycemia during the hospital stay. Recently, the long-acting "basal" insulin glargine (Lantus®, Sanofi Aventis Pharmaceuticals) has been shown to facilitate glycemic control with lower rate of hypoglycemic events than intermediate-acting insulin in subjects with type 1 and type 2 diabetes. This study aims i) to determine the effects of giving a dose of glargine insulin shortly after starting an intravenous insulin infusion on glycemic control, time to resolve DKA, and rate of hypoglycemia in patients with DKA, and ii) to compare the safety and efficacy of basal/bolus (glargine/glulisine) insulin versus the standard split-mixed insulin regimen of NPH and regular insulin after the resolution of DKA. The hypothesis is that basal (lantus®) insulin as compared to NPH insulin shortly after the start of insulin infusion will improve inpatient glycemic control in patients with DKA.

Diabetic Ketoacidosis

Diabetic ketoacidosis insulin therapy DKA

null

2

arm 1: Daily insulin glargine + glulisine before meals arm 2: Split-mixed NPH + Regular insulin twice daily

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Daily insulin glargine + glulisine before meals intervention 2: Split-mixed NPH + Regular insulin twice daily

intervention 1: insulin glargine+ glulisine intervention 2: NPH + Regular insulin

2

0

NCT00590044

[ 0 ]

38

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

true

0ALL

true

This project aims to define mechanisms through which varenicline might be an effective smoking cessation medication.

Thirty treatment seeking smokers will be recruited to complete a 40-day within-subject (cross-over), double-blind study that will assess effects of varenicline on brain activation while performing certain tasks. Prior to beginning the study, participants will complete an health and physical screening to determine final eligibility. Following a medication run-up and a 3.5 day abstinence period, participants will complete study period 1 (an fMRI scan while performing attention, working memory and emotion tasks). After a 14 to 21-day washout period the study procedures will be repeated with placebo (order of study medication counterbalanced). After completion of both study periods, all participants will be offered a 13-week quit smoking program with varenicline.

Nicotine Dependence

Varenicline, Imaging, fMRI

null

2

arm 1: None arm 2: None

[ 2, 1 ]

2

[ 0, 0 ]

intervention 1: Day 1 - Day 3 0.5mg once daily Day 4 - Day 7 0.5mg twice daily Day 8 - Day 13 1.0mg twice daily intervention 2: Participants will take placebo pills for 13 days using the same regimen as the varenicline study period.

intervention 1: Varenicline intervention 2: Placebo

1

Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238

0

NCT00602927

[ 3 ]

245

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This trial is conducted in Africa, Asia and North America. The aim of this trial is to compare two insulin degludec (NN1250, SIBA) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.

null

Diabetes Diabetes Mellitus, Type 2

null

4

arm 1: None arm 2: None arm 3: None arm 4: None

[ 0, 0, 0, 1 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Treat-to-target dose titration scheme, s.c. injection. intervention 2: Formulation D: Treat-to-target dose titration scheme, s.c. injection, once daily intervention 3: Formulation E: Treat-to-target dose titration scheme, s.c. injection, once daily intervention 4: Formulation D: Treat-to-target dose titration scheme, s.c. injection, 3 times weekly intervention 5: Tablets, 1500-2000 mg/day

intervention 1: insulin glargine intervention 2: insulin degludec intervention 3: insulin degludec intervention 4: insulin degludec intervention 5: metformin

29

0

NCT00611884

[ 3 ]

30

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is: 1. To assess and characterize the PK and PD of PRO 140 administered IV 2. To assess the antiviral activity of PRO 140 3. To assess the safety and tolerability of PRO 140

null

HIV Infections

HIV treatment naïve

null

3

arm 1: 10 mg/kg PRO 140, one IV dose (N=10) arm 2: 5 mg/kg PRO 140, one IV dose (N=10) arm 3: Placebo, one IV dose (N=10)

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: 10 mg/kg PRO 140, one IV dose (N=10) intervention 2: 5 mg/kg PRO 140, one IV dose (N=10) intervention 3: PBO, one IV dose (N=10)

intervention 1: PRO 140 intervention 2: PRO 140 intervention 3: Placebo

1

Tarrytown | New York | United States | -73.85875 | 41.07621

0

NCT00613379

[ 3 ]

182

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble Insulin Analogue Combination \[SIAC\], insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive subjects with type 2 diabetes.

null

Diabetes Diabetes Mellitus, Type 2

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily intervention 2: Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily intervention 3: Treat-to-target dose titration scheme, injection s.c., twice daily intervention 4: Tablets, 1500-2000 mg/daily

intervention 1: insulin degludec/insulin aspart intervention 2: insulin degludec/insulin aspart intervention 3: biphasic insulin aspart intervention 4: metformin

31

Helsinki | N/A | Finland | 24.93545 | 60.16952 Kuopio | N/A | Finland | 27.67703 | 62.89238 Lahti | N/A | Finland | 25.66151 | 60.98267 Pori | N/A | Finland | 21.78333 | 61.48333 Bar-le-Duc | N/A | France | 5.16108 | 48.77275 Grenoble | N/A | France | 5.71479 | 45.17869 Hayange | N/A | France | 6.06278 | 49.32881 La Rochelle | N/A | France | -1.15222 | 46.16308 Nanterre | N/A | France | 2.20675 | 48.89198 Nevers | N/A | France | 3.159 | 46.98956 Pointe à Pitre | N/A | France | 1.98937 | 44.07984 Berlin | N/A | Germany | 13.41053 | 52.52437 Pirna | N/A | Germany | 13.93702 | 50.95843 Riesa | N/A | Germany | 13.29168 | 51.30777 Saarbrücken | N/A | Germany | 7.00982 | 49.23262 Saint Ingbert | N/A | Germany | N/A | N/A Völklingen | N/A | Germany | 6.85873 | 49.25162 Wangen | N/A | Germany | 9.83247 | 47.6895 Bydgoszcz | N/A | Poland | 18.00762 | 53.1235 Gniewkowo | N/A | Poland | 18.40785 | 52.89461 Nysa | N/A | Poland | 17.33437 | 50.47379 Płock | N/A | Poland | 19.70638 | 52.54682 Szczecin | N/A | Poland | 14.55302 | 53.42894 Tychy | N/A | Poland | 18.96641 | 50.13717 Warsaw | N/A | Poland | 21.01178 | 52.22977 Wroclaw | N/A | Poland | 17.03333 | 51.1 Almería | N/A | Spain | -2.45974 | 36.83814 Barcelona | N/A | Spain | 2.15899 | 41.38879 Granada | N/A | Spain | -3.60667 | 37.18817 Madrid | N/A | Spain | -3.70256 | 40.4165 San Juan | N/A | Spain | -1.16667 | 39.53333

0

NCT00613951

[ 0 ]

11

RANDOMIZED

PARALLEL

2DIAGNOSTIC

2DOUBLE

true

1FEMALE

false

The investigators propose to test the hypothesis that the use of a prostaglandin inhibitor will result in premature luteolysis (ovulation failure) in women.

Currently available methods of emergency contraception (EC) only work during a very narrow time period prior to the hormonal trigger for ovulation or the release of an egg. Women having unprotected sex outside this window receive no benefits from this emergency therapy. Prostaglandins are critical before, during, and after ovulation, thus their inhibition may cause an EC effect that works over a longer time period. We wanted to determine if celecoxib might work as an EC with a wider window of action.

Ovulation (Follicular Rupture Yes/no) Menstrual Cycles (Total Length, Bleeding Days) Gonadotropin and Ovarian Hormone Levels (FSH, LH, E2, P)

Celebrex prostaglandin inhibitor ovulation menstrual cycles

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: One 400mg tablet daily. intervention 2: One tablet daily.

intervention 1: Celebrex intervention 2: Placebo

1

Portland | Oregon | United States | -122.67621 | 45.52345

0

NCT00614406

[ 4 ]

96

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

false

This study was conducted to provide detailed information on the efficacy of indacaterol (in terms of the spirometry assessment forced expiratory volume in 1 second \[FEV1\]) over the full 24-h time period

null

Chronic Obstructive Pulmonary Disease (COPD)

COPD, bronchodilator, long acting beta agonist, LABA

null

12

arm 1: In period I, indacaterol 300 μg once a day in the morning delivered via single dose dry powder inhaler (SDDPI) with a placebo to salmeterol delivered via dry powder inhaler (DPI). Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, Salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and second dose in the evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. arm 2: In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. arm 3: In period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose was in the evening along with placebo matching indacaterol delivered by SDDPI. In period II, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. arm 4: In period I, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, salmeterol 50 μg twice daily delivered via dry powder inhaler (DPI). One of the two daily doses of salmeterol was administered in the morning and the second dose was in the evening along with placebo matching indacaterol delivered by SDDPI. In period III, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via dry DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. arm 5: In period I, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, During morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, Patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. arm 6: In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period II, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. arm 7: In period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. arm 8: In period I, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via dry powder inhaler DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. arm 9: In period I, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. arm 10: In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via dry powder inhaler DPI. In period II, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. arm 11: In period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. arm 12: In period, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.

[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI) intervention 2: 50 µg twice daily delivered via dry powder inhaler (DPI) intervention 3: Placebo matching indacaterol was delivered via SDDPI. intervention 4: Placebo matching salmeterol was delivered via DPI

intervention 1: Indacaterol intervention 2: Salmeterol intervention 3: Placebo to Indacaterol intervention 4: Placebo to Salmeterol

7

Beuvry | N/A | France | 2.68541 | 50.51674 Nantes | N/A | France | -1.55336 | 47.21725 Berlin | N/A | Germany | 13.41053 | 52.52437 Hamburg | N/A | Germany | 9.99302 | 53.55073 Leipzig | N/A | Germany | 12.37129 | 51.33962 Mainz | N/A | Germany | 8.2791 | 49.98419 Barcelona | N/A | Spain | 2.15899 | 41.38879

0

NCT00615030

[ 3 ]

65

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo.

null

Chronic Obstructive Pulmonary Disease (COPD)

COPD tolerability inhalation

null

2

arm 1: AZD4818 arm 2: Placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Dry Powder, inhalation, b.i.d., 4 weeks intervention 2: None

intervention 1: AZD4818 intervention 2: Placebo

12

Hvidovre | N/A | Denmark | 12.47708 | 55.64297 København NV | N/A | Denmark | 12.52343 | 55.71258 Odense C | N/A | Denmark | 10.39538 | 55.40841 Helsinki | N/A | Finland | 24.93545 | 60.16952 Preitilä | N/A | Finland | 22.73781 | 60.46203 Tampere | N/A | Finland | 23.78712 | 61.49911 Breda | N/A | Netherlands | 4.77596 | 51.58656 Groningen | N/A | Netherlands | 6.56667 | 53.21917 Elverum | N/A | Norway | 11.56231 | 60.88191 Oslo | N/A | Norway | 10.74609 | 59.91273 Trondheim | N/A | Norway | 10.39506 | 63.43049 Lund | N/A | Sweden | 13.19321 | 55.70584

0

NCT00629239

[ 5 ]

83

RANDOMIZED

PARALLEL

1PREVENTION

3TRIPLE

true

0ALL

false

The purpose of this study is to test whether ACULAR, a nonsteroidal anti-inflammatory eye drop medication, can prevent the development of retinopathy of prematurity (ROP) and/ or decrease its severity.In this study ACULAR will be compared to a placebo (artificial tear). The hypothesis would be that ACULAR treatment will decrease the incidence of moderate to severe ROP (grade II and above)by 50%.

Each year ROP affects an estimated 14,000-16,000 premature, low birth weight infants in the United States and thousands more worldwide, making it a leading cause of vision loss in children. Of these cases, approximately 1500 infants will develop severe ROP that requires surgical treatment. Despite those treatment, about 400-600 infants with severe ROP still become legally blind each year. ACULAR® (Ketorolac eye drop) is a member of nonsteroidal anti-inflammatory drugs (NSAIDs) available for toipcal ocular use. ACULAR acts as prostaglandin inhibitor and as such decrease prostaglandin E2 production. An increase in prostaglandin production has been associated with various inflammatory eye disease.For instance ACULAR has been shown to be effective in preventing the post cataract surgery inflammation that result in macular edema in adults. Activation of the prostaglandin cascade has been demonstrated in animal models of ROP. A previous non randomized study using ACULAR for ROP prevention has shown a possible beneficial effect and no observed adverse effect. To clearly demonstrated and confirm this finding a randomized study is thus necessary before one can advocate its use for prevention of ROP.The medication is FDA approved in pediatrics for allergic conjunctivitis and post surgical ocular inflammation.

Retinopathy of Prematurity Retinal Detachment Blindness

Retinopathy of Prematurity Premature Infants ACULAR Refresh Tears

null

2

arm 1: None arm 2: None

[ 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours. intervention 2: infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours. intervention 3: None

intervention 1: ACULAR intervention 2: REFRESH TEARS intervention 3: placebo

1

Mobile | Alabama | United States | -88.04305 | 30.69436

0

NCT00634972

[ 3 ]

27

RANDOMIZED

CROSSOVER

4SUPPORTIVE_CARE

4QUADRUPLE

false

0ALL

false

This study evaluated the effect of QAB149 on dynamic and static hyperinflation, breathlessness, and health status in COPD patients

null

Chronic Obstructive Pulmonary Disease

COPD, Indacaterol Maleate, Exercise testing

null

2

arm 1: In period I, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study. arm 2: In period I, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 300μg indacaterol maleate inhalation powder in hard gelatin capsules administered via Concept1 inhalation device intervention 2: Matching placebo devices and hard gelatin capsules

intervention 1: Indacaterol 300μg intervention 2: Placebo

3

Berlin | N/A | Germany | 13.41053 | 52.52437 Mönchengladbach | N/A | Germany | 6.44172 | 51.18539 Wiesbaden | N/A | Germany | 8.24932 | 50.08258

0

NCT00636961

[ 5 ]

67

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

1FEMALE

true

After surgery it is normal to experience some pain at the site of operation. In order to reduce the pain, medication such as Morphine is injected into a vein using a Patient Controlled Analgesia (PCA) pump that is kept at bed side, and is activated by the patient when needed. However, Morphine is an opioid drug, which can cause side effects such as sedation, nausea, vomiting, and reduced breathing on prolonged use. In addition to the opioid drugs, local anesthetics, and other drugs called Non steroidal anti inflammatory drugs (NSAIDs) have been injected locally to provide prolonged pain relief without the side effects of morphine. Recently a portable device called ON-Q pump has been developed to continuously infuse the local anesthetic through 2 small catheters inserted at the wound site. The ON-Q Pump is a small tennis ball sized unit made of a soft synthetic material that slowly infuses the drug through the catheters by elastic force. This pump is very safe and is attached to a bedside pole or the patient's hospital gown. This pump has already been approved by the FDA for clinical use, and has been reported to provide effective pain management after some surgical procedures. The primary aim of the present study is to evaluate the relative efficacy of the drugs Ketorolac and Ropivacaine infused through the ON-Q pump in reducing the pain following gynecologic surgery. Ketorolac and Ropivacaine are approved drugs that are frequently used for post operative pain relief. Our hypothesis is that these two drugs in combination will provide better analgesia than Ketorolac alone.

This study would include a total of 60 patients randomized into 2 equal groups. Patients will be interviewed in the holding area and informed signed consent will be obtained. Patients will be induced with general anesthesia in keeping with standard practice. At the end of surgical procedure, before the patient is extubated, the Surgeon will secure the 2 catheters of the ON-Q pump at two levels of the fascia near the incision site. First the surgeon will instill at the wound site a bolus dose of 30 ml of 0.9% saline with 10 mg Ketorolac in Group I, or 30 ml of saline with 0.5% Ropivacaine and 10 mg Ketorolac in Group II patients. Then the continuous infusion with the ON-Q pump will be started at 4 ml/hr, and Group I patients will receive saline with Ketorolac at 5 mg/hr not to exceed 120 mg per day, and Group II will receive saline with 0.5% Ropivacaine plus Ketorolac at 5 mg/hr. Patients will be extubated, as per standard anesthetic practice. All patients will receive anti ulcer medication. On arrival at the Post Anesthesia Care Unit (PACU), the patient will receive an i.v. PCA pump, which will administer Morphine Sulfate 2 mg in incremental doses on demand by the patient. A blinded investigator will collect the study data from each patient at 6, 12, 24, and 48 hrs postoperative periods. The data collected would include 1) Visual Analog Scale (VAS) scores for pain at rest, on coughing and on moving, 2) PCA demands by the patient and actual deliveries of morphine, 3) "rescue" analgesic requirements (for pain score of 4 or greater). 4) VAS scores for Nausea, drowsiness, and satisfaction, and 5) number of vomiting.

Postoperative Pain

null

2

arm 1: Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day arm 2: Patients will receive Ketorolac 5 mg and Ropivacaine 0.5% (Group 2) via an infusion catheter at the incision site

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day intervention 2: Patients will receive Ketorolac at 5 mg/hr plus 0.5% Ropivacaine

intervention 1: Ketorolac intervention 2: Ketorolac and Ropivacaine

1

Brooklyn | New York | United States | -73.94958 | 40.6501

0

NCT00638508

[ 5 ]

48

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is primarily aimed at restoring dopamine function in the brain. Oral selegiline in conjunction with L-dopa has been a mainstay of therapy for PD patients experiencing motor fluctuations for many years. The mechanisms accounting for selegiline's beneficial adjunctive action in the treatment of PD are not fully understood. Inhibition of monoamine oxidase (MAO) type B (MAO-B) activity is generally considered to be of primary importance. Oral selegiline has low bio-availability and is typically dosed BID, for a total of 5-10 mg daily. Recently, the FDA approved a new orally disintegration tablet (ODT) formulation of selegiline, called ZelaparTM. This new formulation utilizes Zydis technology to dissolve in the mouth, with absorption through the oral mucosa, thereby largely bypassing the gut and avoiding first pass hepatic metabolism. This allows more active drug to be delivered at a lower dose. Consequently, Zelapar is dosed once-daily, up to 2.5 mg per day. There are no empirical data indicating whether the use of the new approved formulation of selegiline ODT (Zelapar) is superior or preferred by patients compared to traditional oral selegiline. It is believed that clinical efficacy will be preserved or enhanced, by delivering more active drug, with improved patient preference for the ODT formulation due to the once-daily dosing . The effectiveness of orally disintegrating selegiline as an adjunct to carbidopa/levodopa in the treatment of PD was established in a multicenter randomized placebo-controlled trial (n=140; 94 received orally disintegrating selegiline, 46 received placebo) of three months' duration. Patients randomized to orally disintegrating selegiline received a daily dose of 1.25 mg for the first 6 weeks and a daily dose of 2.5 mg for the last 6 weeks. Patients were all treated with levodopa and could additionally have been on dopamine agonists, anticholinergics, amantadine, or any combination of these during the trial. At 12 weeks, orally disintegrating selegiline-treated patients had an average of 2.2 hours per day less "OFF" time compared to baseline. Placebo treated patients had 0.6 hours per day less "OFF" time compared to baseline. These differences were significant (p \< 0.001). Adverse events were very similar between drug and placebo.

This is an open label, multicenter, 6 week study of the conversion from oral selegiline to orally disintegrating selegiline in PD patients with or without motor fluctuations, and currently taking levodopa. The study consists of the substitution of the oral selegiline with 1.25 mg of orally disintegrating selegiline for 10 days, and up titration of orally disintegrating selegiline to 2.5 mg per day for the next 30 days. The study will consist of 2 study visits in the clinic: Baseline and Day 40, and a telephone visit at Day 10. Inclusion Criteria: 1\. Idiopathic PD confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity 2. Male or female outpatients 3. Age 30-90 years 4. Current use of levodopa and oral selegiline (5-10 mg /day), stable for at least 1 month and well tolerated 5. Positive treatment response to current anti-parkinsonian medications in the opinion of the investigator 6. Acceptable contraception for females of child bearing potential 7. Willing and able to comply with study procedures. 8. Willing and able to give written informed consent prior to beginning any study procedures. Exclusion Criteria: 1\. Atypical parkinsonism due to drugs, metabolic disorders, encephalitis, trauma, or other neurodegenerative diseases. 2. Significant cognitive or psychiatric impairment which, in the opinion of the investigator, would interfere with the ability to complete all the tests required in the protocol. 3. Participation in another clinical drug trial within the previous four weeks. 4. Patients on any medications contraindicated with Zelapar (including meperidine/Demerol, tramadol, methadone, propoxyphene, dextromethorphan, other selegiline products) 5. Patients with a known hypersensitivity to any formulation of selegiline or any of the inactive ingredients of Zelapar, or previous exposure to orally disintegrating selegiline 6. History of melanoma 7. Unstable/uncontrolled medical problems 8. History of drug/alcohol abuse 9. Patients currently taking rasagiline The primary efficacy point is number of subjects who prefer Zydis selegiline vs. the number who prefer oral selegiline, or have no preference. Descriptive statistics will be used to present the percentages of persons and adverse event resolutions. The secondary endpoints will include changes in the UPDRS, PDQ-8, BDI, FSS, ESS, ratings of global improvement and change in dyskinesia from Baseline to the Day 40 visit. Appropriate parametric (t-tests) and non-parametric analyses (Wilcoxon signed rank comparisons) will be conducted based on the scale being analyzed. An intent to treat approach will be used in which all subjects receiving at least one dose of study medication will be included in the analyses. Tolerability and efficacy of switching from oral selegiline to Zydis selegiline in patients with Parkinson's disease.

Parkinson's Disease

Parkinson's disease selegiline to Zelapar switch orally disintegrating formulation

null

1

arm 1: Open label switch from current oral selegiline dose to orally disintegrating selegiline (Zelapar) titrated to a dose of 2.5 mg QD.

[ 0 ]

1

[ 0 ]

intervention 1: Switch from oral selegiline to Zelapar 1.25 mg QD titrated to 2.5 mg QD

intervention 1: Zelapar

5

0

NCT00640159

[ 2 ]

85

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

0ALL

false

The purpose of this study is to evaluate the exposure of rifabutin (RIB) when administered with atazanavir and ritonavir (ATV/RTV)

null

Antivirals/HIV

null

2

arm 1: None arm 2: None

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Capsule, Oral, 150 mg, once daily, 11 Days intervention 2: Capsules, Oral, 18 Days Rifabutin (150 mg, 2x/wk) Atazanavir (300 mg, once daily) Ritonavir (100 mg, once daily)

intervention 1: Rifabutin intervention 2: Rifabutin + Atazanavir + Ritonavir

1

Hamilton | New Jersey | United States | -74.08125 | 40.20706

0

NCT00646776

[ 3 ]

52

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

The specific objective of this trial is to determine the lowest dose and dose frequency possible with the best pharmacokinetic and safety profile and it's ability to remove a blood clot from the ventricular system.

The purpose of this trial is to determine the efficacy and pharmacokinetics of intraventricular injections of multiple low doses of rt-PA. Sixteen subjects were already randomized to receive intraventricular injections of with 0.3 mg or 1.0 mg of rt-PA every 12 hours for up to 8 doses. Results of this stage (n=16) were then analyzed and the most effective dose of 1.0 mg was chosen to be used in the second stage (n=36) to determine the optimal frequency of dosing. We propose to test if this intervention facilitates more rapid clot resolution, complete recovery function and decreased mortality from this condition.

Intraventricular Hemorrhage

Intraventricular hemorrhage (IVH) rt-PA

null

3

arm 1: In stage 1 of the protocol, dose finding, subjects were randomized to either this 0.3 mg dose arm or the 1.0 mg dose arm. Subjects in this arm (0.3 mg) received up to 8 doses of 0.3 mg rt-PA every 12 hours through the intraventricular catheter to treat intraventricular hemorrhage. arm 2: In stage 1 of the protocol, dose finding, subjects were randomized to either this 1.0 mg dose arm or the 0.3 mg dose arm. Subjects in this arm (1.0 mg) received up to 8 doses of 1.0 mg rt-PA every 12 hours through the intraventricular catheter to treat intraventricular hemorrhage. arm 3: In stage 2 of the protocol, dose frequency, subjects received up to 8 doses of 1.0 mg of rt-PA (Cathflo) every 8 hours through the intraventricular catheter to treat intraventricular hemorrhage.

[ 1, 1, 0 ]

1

[ 0 ]

intervention 1: 0.3 mg and 1.0 mg of rt-PA (Cathflo) were administered every 12 hours (dose finding) and every 8 hours (dose frequency) via the intraventricular catheter to treat intraventricular hemorrhage.

intervention 1: tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo)

25

0

NCT00650858

[ 3 ]

81

RANDOMIZED

CROSSOVER

1PREVENTION

4QUADRUPLE

true

1FEMALE

false

The purpose of this study is to determine whether lidocaine vaginal gel is safe and effective for preventing or reducing the severity of dysmenorrhea (painful menstrual periods) compared to placebo (inactive gel).

The primary objective of this study is to evaluate the efficacy of 10% (150 mg) lidocaine gel compared with placebo in reducing the severity and onset of primary dysmenorrhea in women with recurrent dysmenorrhea. The secondary objectives of this study are the following: * to assess the safety of 10% (150 mg) lidocaine gel compared with placebo * to evaluate electrocardiograms (ECGs) for potentially significant QT changes at approximate peak lidocaine plasma concentration after 4 days of dosing with 10% (150 mg) lidocaine gel.

Dysmenorrhea

Dysmenorrhea Periods Menstrual Primary dysmenorrhea in women with recurrent dysmenorrhea

null

2

arm 1: Lidocaine 10% (150mg) vaginal gel arm 2: Placebo vaginal gel

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Lidocaine vaginal gel 10% (150mg) administered once daily for 4 days intervention 2: Placebo vaginal gel administered once daily for 4 days

intervention 1: Lidocaine intervention 2: Placebo

4

0

NCT00651313

[ 2, 3 ]

12

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

true

0ALL

null

Study is intended to evaluate safety and efficacy parameters in patients treated with GLYC-101 gel or placebo after laser ablation.

The proposed pilot-study will document feasibility, safety and efficacy of topically applied Glucoprime gel (GLYC-101 gel 1.0 %) in promoting wound healing in healthy volunteer subjects undergoing retro-auricular Carbon Dioxide Laser Skin Resurfacing (CO2 LSR). The study will observe the effects of the topical agent over the course of 1 month following the treatment. as a preparation for study GLYC-101-1b (Double-blind, randomized, placebo-controlled Phase 2 Pilot Study to investigate the safety and efficacy of 1.0 % topically applied GLYC 101 compared to placebo, in patients undergoing Carbon Dioxide Laser Skin Resurfacing).

Wounds

burn wounds wound healing

null

2

arm 1: GLYC-101 Active Retro-auricular Site (1 per participant) arm 2: Placebo Retro-auricular Site (1 per participant) This arm undergoes laser ablation with subsequent Placebo gel administration

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Administration of Placebo gel on Day 1, 3 and 5 post ablation. intervention 2: Administration on Day 1, 3 and 5 post laser ablation.

intervention 1: Placebo gel intervention 2: GLYC-101 gel (1.0 %)

1

Beverly Hills | California | United States | -118.40036 | 34.07362

0

NCT00656474

[ 0 ]

10

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

true

2MALE

false

Opioid medications are commonly used for pain relief. When given over time, physical dependence can occur. This results in unpleasant side effects--such as agitation and nausea--if opioid medications are suddenly stopped. We are interested in knowing if a medication named Ondansetron can help ease or prevent symptoms associated with opioid withdrawal. We are also interested in knowing if a similar (but more potent FDA-approved drug, palonosetron) can more effectively treat withdrawal symptoms with or without combination with an antihistamine called hydroxyzine (vistaril).

We hope to learn if Palonosetron and/or combination with hydroxyzine can be used to prevent or attenuate the signs and symptoms of opioid withdrawal. If we find that it can help prevent these symptoms, it may become a new treatment that can aid patients suffering from these symptoms.

Substance-Related Disorders

Palonosetron Hydroxyzine Acute opioid withdrawal

null

6

arm 1: At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15. Week 1: Placebo Week 2: Palonosetron + Hydroxyzine Combo Week 3: Palonosetron arm 2: At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15. Week 1: Palonosetron Week 2: Palonosetron + Hydroxyzine Combo Week 3: Placebo arm 3: At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15. Week 1: Palonosetron + Hydroxyzine Combo Week 2: Placebo Week 3: Palonosetron arm 4: At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15. Week 1: Placebo Week 2: Palonosetron only Week 3: Palonosetron + Hydroxyzine Combo arm 5: At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15. Week 1: Palonosetron + Hydroxyzine Combo Week 2: Palonosetron only Week 3: Placebo arm 6: At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15. Week 1: Palonosetron only Week 2: Placebo Week 3:Palonosetron + Hydroxyzine Combo

[ 0, 0, 0, 0, 0, 0 ]

3

[ 0, 0, 10 ]

intervention 1: Over 3 study visits, patients will receive one of the following treatment regimens: * Placebo saline IV and sugar pill * 0.75 mg Palonosetron IV and sugar pill * 0.75 mg Palonosetron IV and 100 mg hydroxyzine PO intervention 2: Over 3 study visits, patients will receive one of the following treatment regimens: * Placebo saline IV and sugar pill * 0.75 mg Palonosetron IV and sugar pill * 0.75 mg Palonosetron IV and 100 mg hydroxyzine PO intervention 3: Over 3 study visits, patients will receive one of the following treatment regimens: * Placebo saline IV and sugar pill * 0.75 mg Palonosetron IV and sugar pill * 0.75 mg Palonosetron IV and 100 mg hydroxyzine PO

intervention 1: Palonosetron intervention 2: Hydroxyzine intervention 3: Placebo

1

Stanford | California | United States | -122.16608 | 37.42411

0

NCT00661674

[ 4 ]

89

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

false

0ALL

false

This study will evaluate the onset of action of indacaterol (150 and 300 µg) as compared to placebo, salbutamol 200 µg and salmeterol/fluticasone 50/500 µg

null

Chronic Obstructive Pulmonary Disease

chronic obstructive pulmonary disease COPD indacaterol adults

null

5

arm 1: Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut), Indacaterol 300 μg (Ind 300μg), Placebo, Salbutamol 200 μg (Salbut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 2: Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 300 μg (Ind 300μg), Indacaterol 150 μg (Ind 150μg), Salbutamol 200 μg (Salbut), Salmeterol/fluticasone 50/500 μg (Salm/flut), Placebo. At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 3: Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Salmeterol/fluticasone 50/500 μg (Salm/flut), Placebo, Indacaterol 150 μg (Ind 150μg), Salbutamol 200 μg (Salbut), Indacaterol 300 μg (Ind 300μg). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 4: Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Salbutamol 200 μg (Salbut), Indacaterol 300 μg (Ind 300μg), Placebo, Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 5: Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Placebo, Salbutamol 200 μg (Salbut), Salmeterol/fluticasone 50/500 μg (Salm/flut), Indacaterol 300 μg (Ind 300μg), Indacaterol 150 μg (Ind 150μg). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

[ 0, 0, 0, 0, 0 ]

6

[ 0, 0, 0, 0, 0, 0 ]

intervention 1: Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI) intervention 2: Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI). intervention 3: Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI). intervention 4: Placebo to indacaterol delivered via SDDPI intervention 5: Placebo to salmeterol/fluticasone delivered via MDDPI intervention 6: Placebo to salbutamol delivered via MDDPI

intervention 1: Indacaterol intervention 2: Salmeterol/fluticasone (50/500 μg) intervention 3: Salbutamol (200 µg) intervention 4: Placebo to Indacaterol intervention 5: Placebo to Salmeterol/fluticasone intervention 6: Placebo to salbutamol

17

Tamarac | Florida | United States | -80.24977 | 26.21286 Lafayette | Louisiana | United States | -92.01984 | 30.22409 Saint Charles | Missouri | United States | -90.48123 | 38.78394 Shelby | North Carolina | United States | -81.53565 | 35.29235 Beaver | Pennsylvania | United States | -80.30478 | 40.69534 Antwerp | N/A | Belgium | 4.40026 | 51.22047 Berlin | N/A | Germany | 13.41053 | 52.52437 Borstel | N/A | Germany | 8.96896 | 52.67034 Dortmund | N/A | Germany | 7.466 | 51.51494 Hamburg | N/A | Germany | 9.99302 | 53.55073 Hanover | N/A | Germany | 9.73322 | 52.37052 Mainz | N/A | Germany | 8.2791 | 49.98419 Potsdam | N/A | Germany | 13.06566 | 52.39886 Wiesbaden | N/A | Germany | 8.24932 | 50.08258 Debrecen | N/A | Hungary | 21.62444 | 47.53167 Deszk | N/A | Hungary | 20.24322 | 46.21802 Nyíregyháza | N/A | Hungary | 21.71671 | 47.95539

0

NCT00669617

[ 5 ]

100

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris.

Same as above.

Acne Vulgaris

null

1

arm 1: adapalene gel, 0.3% Other Names: Differin® Gel, 0.3% Applied once daily at bedtime clindamycin/benzoyl peroxide gel Other Names: Duac® Gel Applied once daily in the morning

[ 0 ]

2

[ 0, 0 ]

intervention 1: Applied once daily at bedtime intervention 2: Applied once daily in the morning

intervention 1: adapalene gel, 0.3% intervention 2: clindamycin/benzoyl peroxide gel

4

0

NCT00671749

[ 0 ]

16

RANDOMIZED

SINGLE_GROUP

0TREATMENT

2DOUBLE

true

0ALL

false

This study is an exploratory trial evaluating the tear film break-up time after a single eye drop instillation of over-the-counter artificial tears. The primary hypothesis is that tear film break up time will be greater for test than control eye.

Subjects with varying degrees of dry eye syndrome were enrolled in a randomized, controlled, double masked, single site study. A new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient was compared against a leading commercial product with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent. The primary outcome was a comparison of tear film stability after eye drop instillation.

Keratoconjunctivitis Sicca

ocular lubricants

null

2

arm 1: One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient. arm 2: The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Eye drop with active agent glycerin 1%, new topical ophthalmic formulation with polylysine-graft-polyethylene glycol as an excipient, single instillation. intervention 2: Eye drop with the active agents polyethylene glycol 400 0.4% /propylene glycol 0.3%, topical ophthalmic formulation, single instillation

intervention 1: glycerin intervention 2: polyethylene glycol 400/propylene glycol

1

Rochester | New York | United States | -77.61556 | 43.15478

0

NCT00681265

[ 5 ]

232

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

2MALE

false

Benign prostatic hyperplasia (BPH) is a common condition among older men. The efficacy of α1-blockers for treating BPH has been well documented and they are recommended for the treatment of BPH by clinical guidelines. It is not well known if a stratification based on the grade of BOO and bladder contractility has any predictive value for patients who are treated with an α1-selective blocking agent. In our study, we investigated possible differences in treatment outcome between patients with and without BOO, and with or without proper contractility who are treated with alfuzosin. So we will compare the quantified improvements 12 months after alfuzosin medication in LUTS/BPH patients by the grade of BOO and/or bladder contractility.

1. Primary objective To evaluate efficacy on voiding and storage symptoms in LUTS/BPH patients after 12 months of treatment with Xatral XL® by the grade of bladder outlet obstruction and/or bladder contractility 2. Secondary objectives To evaluate efficacy on voiding and storage symptoms in LUTS/BPH patients after 3 months and 6 months of treatment with Xatral XL® by the grade of bladder outlet obstruction and/or bladder contractility To evaluate efficacy on maximal flow rate (MFR) and post-voided residual urine (PVR) To evaluate on voiding frequency, urgency severity \& frequency, and nocturia To evaluate patient tolerability to the medication To evaluate global impression of improvement (GII)

BPH

LUTS BPH bladder outlet obstruction bladder contractility

null

4

arm 1: Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month. arm 2: BOOI≥ 20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month. arm 3: BOOI\<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month. arm 4: BOOI\<20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month.

[ 1, 1, 1, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 10mg, once daily, 12months intervention 2: 10mg, once daily, 12months intervention 3: 10mg, once daily, 12months intervention 4: 10mg, once daily, 12months

intervention 1: Alfuzosin intervention 2: Alfuzosin intervention 3: Alfuzosin intervention 4: Alfuzosin

0

null

0

NCT00696761

[ 3 ]

30

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

true

0ALL

false

The purpose of this study is to assess the abuse liability of 4 times (8 tablets) the usual recommended dose of Acurox (oxycodone HCl 40 mg plus niacin 240 mg) versus oxycodone HCL 40 mg alone in subjects with a history of opioid abuse.

In the Treatment Phase, subjects randomly received oxycodone HCl 40 mg administered in combination with niacin 240 mg and oxycodone HCl 40 mg alone in crossover design. 15 subjects were randomized to receive oxycodone/niacin first followed by oxycodone with a 48 hour washout between doses. 15 subjects randomized to receive oxycodone before the oxycodone/naicin dose with a 48 hour washout between doses. The purpose of the Treatment Phase was to assess the abuse liability and abuse deterrence potential of 4 times the recommended 2-tablet dose of Acurox® Tablets 5/30 mg versus oxycodone HCl 40 mg alone (8 tablets per dose). All 30 subjects received a single dose of each study treatment. Subjects were fasted prior to dosing on all dose days.

Opioid Abuse

Abuse Liability Abuse Prevention Abuse Resistance Abuse Deterrence

null

2

arm 1: oxycodone HCl/Niacin 5/30mg tablets; 8 tablets per dose arm 2: oxycodone HCl 5mg tablets; 8 tablets per dose

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: followed by oxycodone 5mg with 48 hour washout intervention 2: followed by Acurox 5/30mg with 48 hour washout

intervention 1: Acurox 5/30mg taken first intervention 2: Oxycodone 5mg taken first

1

Baltimore | Maryland | United States | -76.61219 | 39.29038

0

NCT00699010

[ 5 ]

8

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

true

0ALL

false

The purpose of this study is to evaluate the effects of a combination of hydroxcycitrate (HCA) and niacin-bound chromium, in conjunction with nutrition education, over a twelve week period. Participants will be evaluated with regard to BMI, percent body fat, insulin activity, and hunger.

The prevalence of obesity among youth has increased dramatically in recent years. Parallel to the increased rates of pediatric obesity, overweight children present clinically with adiposity related comorbidities such as insulin resistance and type 2 diabetes. The prevailing recommendations for overweight youth are to increase physical activity levels and limit energy intake in order to improve body composition. Currently there is little empirical evidence to support the efficacy of these recommendations. Alternatively, evidence in adults suggests that nutritional supplementation with (-) hydroxycitric acid (HCA), an organic acid found naturally in citrus fruits, and chromium may lead to favorable changes in body composition and improve glucose regulation. To date, these issues have not been tested in youth. Therefore, the purpose of the present investigation is to examine the effects of a nutritional education program combined with either HCA + chromium or placebo on measures of body composition and glucose regulation in overweight adolescents.

Obesity Diabetes Mellitus, Type 2

null

2

arm 1: nutrition education plus active supplement arm 2: nutrition education plus inactive supplement

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: After all baseline measures have been completed, participants will be randomly assigned to either the nutrition education + supplement group, or the nutrition education + placebo group. The length of the intervention is twelve weeks. Nutrition classes will take place once a week for 1 1/2 hours. Subjects will be encouraged to increase fiber and decrease sugar intake. They will also be separated into gender-specific classes. Active and inactive supplements will be identical in appearance and taste. Active supplements will contain 2,700 mgs/day of Super CitriMax (hydroxycitrate)and 400 µg per day of ChromeMate (niacin-bound Chromium). Supplements will be in powder and tablet form, and should be taken 30 minutes prior to each meal. intervention 2: After all baseline measures have been completed, participants will be randomly assigned to either the nutrition education + supplement group, or the nutrition education + placebo group. The length of the intervention is twelve weeks. Nutrition classes will take place once a week for 1 1/2 hours. Subjects will be encouraged to increase fiber and decrease sugar intake. They will also be separated into gender-specific classes. Active and inactive supplements will be identical in appearance and taste.

intervention 1: nutrition education plus active supplement intervention 2: nutrition education plus inactive supplement

1

Los Angeles | California | United States | -118.24368 | 34.05223

0

NCT00699413

[ 3 ]

64

RANDOMIZED

PARALLEL

7BASIC_SCIENCE

4QUADRUPLE

false

0ALL

false

Study of T-PRED(TM) compared to Pred Forte(R)

null

Cataract

null

2

arm 1: Tobramycin prednisolone acetate combination arm 2: Prednisolone acetate

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: T-PRED sterile ophthalmic solution intervention 2: Pred Forte sterile ophthalmic solution

intervention 1: T-PRED intervention 2: Pred Forte

1

Irvine | California | United States | -117.82311 | 33.66946

0

NCT00699803

[ 5 ]

478

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This study was a multicenter, randomized, PROBE-type (prospective, randomized, open label, blinded end-point) study of 12 weeks duration comprising four visits, carried out in patients with essential arterial hypertension not controlled on four weeks treatment with amlodipine 5 mg alone.

null

Hypertension

Hypertension ambulatory blood pressure monitoring

null

2

arm 1: After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP \>= 140 mmHg and/or msDBP \>= 90 mmHg or msSBP \>= 130 mmHg and/or msDBP \>= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP \< 140 mmHg and msDBP \< 90 mmHg or msSBP \< 130 mmHg and msDBP \< 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study. arm 2: After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP \>= 140 mmHg and/or msDBP \>= 90 mmHg or msSBP \>= 130 mmHg and/or msDBP \>= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP \< 140 mmHg and msDBP \< 90 mmHg or msSBP \< 130 mmHg and msDBP \< 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 5 mg or 10 mg tablets. intervention 2: 160 mg capsules.

intervention 1: Amlodipine intervention 2: Valsartan

2

Paris | N/A | France | 2.3488 | 48.85341 Tunisia | N/A | Tunisia | N/A | N/A

0

NCT00700271

[ 5 ]

16

RANDOMIZED

CROSSOVER

2DIAGNOSTIC

1SINGLE

true

0ALL

false

The purpose of this study is to use functional magnetic resonance imaging (fMRI) in healthy controls to examine the acute effects of certain anxiolytic medications on brain function.

Increased amygdala and insula activity have been implicated in neurobiological models of anxiety. Using fMRI, the anxiolytic medication, lorazepam, has previously been found to decrease activation in these areas during the processing of emotional stimuli. This study aims to replicate those results but by using a different medication, alprazolam. An eventual aim of this study, in combination with future studies, is to evaluate the utility of fMRI as a tool to identify anxiolytic function in both established and novel compounds that may be used to treat anxiety.

Anxiety Disorders

functional magnetic resonance imaging fMRI alprazolam anxiety disorders

null

3

arm 1: 0.25 mg alprazolam PO (liquid) will be administered 1 hour prior to fMRI scan. One-time, single dose. Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart. arm 2: 1 mg alprazolam PO (liquid) will be administered 1 hour prior to fMRI scan One-time, single dose. Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart. arm 3: Inactive ingredient in liquid matching appearance and volume of the two active alprazolam dose comparators. Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.

[ 1, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: 0.25 mg alprazolam PO (liquid) to be administered 1 hour prior to fMRI scan Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart. intervention 2: 1 mg alprazolam PO (liquid) will be administered 1 hour prior to fMRI scan Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart. intervention 3: Placebo (liquid) to be administered 1 hour prior to fMRI scan Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.

intervention 1: 0.25 mg alprazolam intervention 2: 1.0 mg alprazolam intervention 3: placebo

1

La Jolla | California | United States | -117.2742 | 32.84727

0

NCT00703885

[ 3 ]

35

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

GSK1349572 is an integrase inhibitor that will be evaluated for the treatment of HIV infection. This phase IIa, multicenter, randomized, parallel, double-blind, dose ranging, placebo-controlled 'proof of concept' study is to be conducted to compare antiviral effect, safety, tolerability, and pharmacokinetics of GSK1349572 monotherapy versus placebo over 10 days in ART-naïve and experienced, but integrase inhibitor naïve (meaning never having had an integrase inhibitor) HIV-1 infected adults who are not currently receiving antiretroviral therapy. This study consists of a screening visit, a treatment period and a follow-up evaluation. Thirty subjects will be randomized to receive one of three doses of GSK1349572 or placebo q24h over 10 days. Antiviral effect measures include viral load and CD4 cell count.

null

Infection, Human Immunodeficiency Virus

dose-ranging study phase IIa integrase inhibitor HIV-1 infection

null

3

arm 1: GSK1349572 2 mg or placebo every 24 hours for 10 days. Screening visit up to 30 days prior to first dose and follow-up for 11 days after last dose. arm 2: GSK1349572 10 mg or placebo every 24 hours for 10 days. Screening visit up to 30 days prior to first dose and follow-up for 11 days after last dose. arm 3: GSK1349572 50 mg or placebo every 24 hours for 10 days. Screening visit up to 30 days prior to first dose and follow-up for 11 days after last dose.

[ 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: GSK1349572 is an experimental drug being developed for the treatment of HIV. It is in the class of integrase inhibitors. intervention 2: Placebo is a tablet with no drug in it.

intervention 1: GSK1349572 intervention 2: Placebo

18

0

NCT00708110

[ 4 ]

19

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

2DOUBLE

true

0ALL

false

The study is designed to compare the abuse liabilities of intravenous buprenorphine and buprenorphine/naloxone in individuals who are physically dependent on sublingual buprenorphine. We hypothesize that the abuse liability of buprenorphine/naloxone is lower than that of buprenorphine alone.

Drug dependence is a major international public health problem of which opioid dependence, notably involving heroin, is a major component. Opioid dependence affects an estimated 13 million injection drug users (IDUs) worldwide. The high health service costs for the treatment of diseases related to non-medical drug use and the high cost to society of drug-related behavior have prompted researchers to seek new medications and treatment strategies for opioid dependence. Buprenorphine, a mu-opiate receptor partial agonist and kappa-opiate receptor antagonist, is one such new medication that has had a significant role in expanding access to effective opioid dependence treatment. It is available as Subutex (buprenorphine alone) or Suboxone (a combination of buprenorphine and naloxone). Although it is commonly believed that the abuse potential of buprenorphine is low, numerous countries have reported illicit diversion of buprenorphine and a growing population of buprenorphine abusers. Theoretically, Suboxone would have lower abuse potential. When used sublingually, as prescribed, the amount of naloxone absorbed is negligible. However, if a patient crushes the tablet and attempts to inject or sniff the medication, the naloxone will become effective as an opioid antagonist and may precipitate withdrawal signs and symptoms in individuals dependent on full opioid agonists and/or attenuate the euphoric effects of the buprenorphine that is also contained in the medication. To date, few laboratory studies have evaluated the abuse liability of buprenorphine in humans using a drug self-administration protocol. We are proposing to evaluate the abuse potential of intravenous (IV) buprenorphine compared to IV buprenorphine/naloxone in buprenorphine-maintained injection drug users (IDUs), incorporating self-administration procedures with other measures of opioid effects. The proposed study will investigate the conditions that affect the self-administration of IV buprenorphine by buprenorphine abusers. The primary aim of the study is to compare the reinforcing effects of IV buprenorphine and IV buprenorphine/naloxone in IDUs maintained on different doses of sublingual buprenorphine (2, 8, and 24 mg/day). Secondary aims of the study are to compare the subjective, performance and physiological effects of IV buprenorphine and IV buprenorphine/naloxone. IV-administered placebo (saline), naloxone alone, and heroin alone will be tested as neutral, negative, and positive control conditions, respectively. Participants (N=12 completers) will reside on an inpatient unit (the General Clinical Research Unit, GCRU) during a 7 to 8-week study. This research will provide useful information for clinicians treating opioid dependent individuals with buprenorphine, and importantly, will provide information about the abuse potential and effects of buprenorphine on multiple measures of human functioning.

Opioid-related Disorders

null

7

arm 1: Heroin 25 mg. Administered intravenously, while participants were under 2, 8 and 24 sublingual (SL) Bup maintenance conditions. arm 2: Naloxone (NAL) .4 mg. Administered intravenously, while participants were under 2, 8 and 24 sublingual (SL) Bup maintenance conditions. arm 3: Combined dosing groups of (4 mg and 8mg of Buprenorphine) for participants who administered a maximum of 8 mg of Bup during the qualification phase. Administered intravenously, while participants were under 2, 8 and 24 sublingual (SL) Bup maintenance conditions. arm 4: Combined dosing groups of (4/1 mg and 8/2mg of Buprenorphine + Naloxone) for participants who administered a maximum of 8 mg of Bup during the qualification phase. Administered intravenously, while participants were under 2, 8 and 24 sublingual (SL) Bup maintenance conditions. arm 5: Combined dosing groups of (8mg and 16mg of Bup) for participants who administered a maximum of 16 mg of Bup during the qualification phase. Administered intravenously, while participants were under 2, 8 and 24 sublingual (SL) Bup maintenance conditions. arm 6: Combined dosing groups of (8/2mg and 16/4mg of Buprenorphine + Naloxone) for participants who administered a maximum of 16 mg of Bup during the qualification phase. Administered intravenously, while participants were under 2, 8 and 24 sublingual (SL) Bup maintenance conditions. arm 7: Intravenous placebo (PCB) administration. Administered intravenously, while participants were under 2, 8 and 24 sublingual (SL) Bup maintenance conditions.

[ 1, 1, 0, 0, 0, 0, 2 ]

7

[ 0, 0, 0, 0, 0, 0, 0 ]

intervention 1: Heroin (25 mg) intervention 2: .4 mg intervention 3: 4 and 8 mg intervention 4: 8mg and 16 mg intervention 5: Buprenorphine/Naloxone 4/1 mg, 8/2 mg intervention 6: Buprenorphine/Naloxone 8/2 mg, 16/4 mg intervention 7: Placebo control administration

intervention 1: Heroin intervention 2: Naloxone intervention 3: Low Bup Dose intervention 4: High Bup Dose intervention 5: Low Bup/Nal Dose intervention 6: High Bup/Nal Dose intervention 7: Placebo (PCB)

1

New York | New York | United States | -74.00597 | 40.71427

0

NCT00710385

[ 4 ]

312

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

0ALL

false

To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium extended-release tablet, compared to placebo in postsurgical dental pain.

null

Toothache

Dental Pain Analgesia

null

2

arm 1: single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery. arm 2: Single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Analgesic efficacy in dental pain; per oral; 1 tablet extended release Naproxen Sodium; with a full glass of water within 4 hours post surgery intervention 2: Inactive ingredient; per oral; 1 lactose based tablet; with a full glass of water within 4 hours post surgery

intervention 1: Naproxen Sodium ER (BAYH6689) intervention 2: Placebo

3

0

NCT00720057

[ 4 ]

600

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to determine the efficacy of pioglitazone, twice daily (BID), combined with metformin versus pioglitazone taken alone and metformin taken alone in treating Type 2 Diabetes Mellitus.

Pioglitazone hydrochloride (ACTOS®) is a member of a class of oral antidiabetic agents known as thiazolidinediones, which act by reducing insulin resistance. Insulin resistance is a key feature of dysmetabolic syndrome and has been suggested to be the common pathophysiologic basis of both atherosclerosis and type 2 diabetes. Pioglitazone binds to peroxisome proliferator-activated receptors, an effect that is associated with altered transcription of genes capable of influencing carbohydrate and lipid metabolism. Metformin hydrochloride is an oral antihyperglycemic drug not chemically or pharmacologically related to thiazolidinediones. Metformin is a biguanide, which has been shown to be effective in improving glycemic control in diabetic patients. Metformin inhibits hepatic glucose production, most likely through an inhibition of gluconeogenesis, and its use is associated with an improvement in tissue sensitivity to insulin. In accordance with published algorithms for the use of combination therapy for the treatment of type 2 diabetes, physicians have traditionally combined metformin with other antidiabetic agents. This study will determine the effect of a fixed-dose combination of metformin with pioglitazone, compared to metformin monotherapy and pioglitazone monotherapy. Study participation is anticipated to be approximately 6.5 months.

Diabetes Mellitus

Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus, Lipoatrophic Dyslipidemia Drug Therapy

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Pioglitazone 15 mg /metformin 850 mg combination, tablets, orally, twice daily for up to 24 weeks. intervention 2: Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks. intervention 3: Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

intervention 1: Pioglitazone and metformin intervention 2: Pioglitazone intervention 3: Metformin

77

0

NCT00727857

[ 0 ]

20

NON_RANDOMIZED

PARALLEL

2DIAGNOSTIC

0NONE

true

1FEMALE

true

The purpose of this study is to determine if a reduction in the enzyme 1-hydroxylase, which activates Vitamin D, is the cause of overactivity of the parathyroid glands (called secondary hyperparathyroidism - normal blood calcium and elevated parathyroid hormone) in a selected group of young patients with normal kidney function.

Vitamin D, an essential nutrient, is produced by the skin after sunlight shines on it. Vitamin D must then be activated by both the liver and the kidneys to perform its function of maintaining strong bones and helping to prevent heart disease, infection, diabetes and cancer. Reduced kidney activation of Vitamin D occurs with advanced age and with all kidney diseases. We have identified a small group of patients who appear to have reduced ability of the kidneys to activate vitamin D, even though they are young and do not have chronic kidney disease. In these patients, we are comparing the ability of their kidneys to activate Vitamin D to that of healthy controls. To stimulate the kidneys to activate Vitamin D, we are giving parathyroid hormone intravenously over 8 hours and collecting blood and urine at baseline, 4 and 8 hours. This type of parathyroid infusion does not cause side effects. The gene that controls this activation is also being studied (by a simple blood test) to look for abnormalities. We are now actively recruiting healthy controls for this study.

Secondary Hyperparathyroidism

hyperparathyroidism parathyroid vitamin D vitamin D deficiency

null

2

arm 1: control subject arm 2: Patient with secondary hyperparathyroidism

[ 1, 0 ]

1

[ 0 ]

intervention 1: Teriparatide will be given by continuous intravenous infusion at a rate of 12 pmol/kg/hr for 8 hours to both "patients" and "controls"

intervention 1: Teriparatide

1

Baltimore | Maryland | United States | -76.61219 | 39.29038

0

NCT00754442

[ 5 ]

14

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The primary objective of this study is to evaluate quality of life changes in Puerto Rican subjects with Rheumatoid Arthritis treated with Humira (adalimumab) as their first Anti-TNF Monoclonal Antibody.

null

Rheumatoid Arthritis

null

1

arm 1: All subjects will receive Adalimumab

[ 0 ]

1

[ 0 ]

intervention 1: 40 mg eow

intervention 1: Humira (adalimumab)

10

Aguada | N/A | Puerto Rico | -67.18824 | 18.37939 Bayamón | N/A | Puerto Rico | -66.15572 | 18.39856 Caguas | N/A | Puerto Rico | -66.0485 | 18.23412 Caguas | N/A | Puerto Rico | -66.0485 | 18.23412 Humacao | N/A | Puerto Rico | -65.82738 | 18.14968 Manatí | N/A | Puerto Rico | -66.49212 | 18.42745 Rio Piedras | N/A | Puerto Rico | -66.04989 | 18.39745 Rio Piedras | N/A | Puerto Rico | -66.04989 | 18.39745 San Juan | N/A | Puerto Rico | -66.10572 | 18.46633 San Juan | N/A | Puerto Rico | -66.10572 | 18.46633

0

NCT00761514

[ 3, 4 ]

216

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purposes of this study are to evaluate the efficacy and safety of desflurane (BLM-240) as an anesthetic agent and to demonstrate the non-inferiority of desflurane to sevoflurane in term of awakening/recovery from anesthesia.

The study evaluates the efficacy and safety of the use of desflurane (BLM-240) (with and without nitrous oxide) in maintenance of general anesthesia in adult patients undergoing surgical procedures typically performed under general anesthesia in Japan (thoracic, abdominal, joints, back, and neck), where analgesics and muscle relaxants are concomitantly used. The study is also intended to demonstrate the non-inferiority of desflurane with nitrous oxide to sevoflurane with nitrous oxide in time to awakening/recovery.

Anesthesia

anesthesia desflurane

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: volatile liquid for inhalation intervention 2: volatile liquid for inhalation with gas for inhalation intervention 3: volatile liquid for inhalation and gas for inhalation

intervention 1: desflurane intervention 2: desflurane/nitrous oxide intervention 3: sevoflurane/nitrous oxide

15

Kagoshima | N/A | Japan | 130.55 | 31.56667 Kyoto | N/A | Japan | 135.75385 | 35.02107 Nagoya | N/A | Japan | 136.90641 | 35.18147 Okayama | N/A | Japan | 133.93333 | 34.65 Osaka | N/A | Japan | 135.50107 | 34.69379 Sapporo | N/A | Japan | 141.35 | 43.06667 Shizuoka | N/A | Japan | 138.38333 | 34.98333 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895

0

NCT00762372

[ 4 ]

6

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

true

0ALL

false

To determine the effect of an amino acid on bacterial glycolytic acid formation in human interdental plaque.

null

Dental Plaque

null

3

arm 1: fluoride/triclosan/copolymer toothpaste arm 2: fluoride only toothpaste arm 3: fluoride/triclosan/amino acid toothpaste

[ 1, 2, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Rinse 3 times daily with assigned toothpaste slurry intervention 2: Rinse 3 times daily with assigned toothpaste slurry intervention 3: Rinse 3 times daily with assigned toothpaste slurry

intervention 1: Triclosan, Fluoride intervention 2: fluoride intervention 3: Fluoride, triclosan, amino acid

1

Zurich | N/A | Switzerland | 8.55 | 47.36667

0

NCT00762450

[ 4 ]

44

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

0ALL

false

The objective is to compare two commerical oral products for the treatment of gingivitis.

null

Dental Plaque

null

2

arm 1: commercially available Fluoride only toothpaste arm 2: Commercially available triclosan/copolymer/fluoride toothpaste

[ 2, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Brush teeth two times daily for 6 weeks intervention 2: Brush two times daily for 6 weeks intervention 3: Brush two times daily for 6 weeks

intervention 1: Fluoride intervention 2: Triclosan intervention 3: Fluoride

1

Louisville | Kentucky | United States | -85.75941 | 38.25424

0

NCT00762515

[ 4 ]

105

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

true

0ALL

false

The efficacy of two dentifrices in controlling gingivitis and plaque in adults with implants

null

Gingival Diseases

null

2

arm 1: fluoride toothpaste (Ultrabrite) arm 2: fluoride/triclosan/copolymer toothpaste

[ 2, 1 ]

2

[ 0, 0 ]

intervention 1: Brush twice daily intervention 2: Brush twice daily

intervention 1: Fluoride intervention 2: Triclosan, fluoride

2

Buffalo | New York | United States | -78.87837 | 42.88645 Jerusalem | N/A | Israel | 35.21633 | 31.76904

0

NCT00762619

[ 4 ]

60

RANDOMIZED

CROSSOVER

null

0NONE

true

0ALL

false

Open-label randomized crossover design study. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7.

Enrolled participants were divided into 2 groups, with 30 participants in each group. Group 1: This group was randomized into a single-dose, 2-way crossover design. These participants received single administrations (day 1 dosing only) of Zegerid OTC Capsules, and Prilosec OTC Tablets (both at a 20 mg omeprazole dose), in a 2-way randomized order, with a minimum of a 2-week washout period between treatment legs. This group underwent a 24-hour intragastric pH study on each of the 2 dosing occasions. Group 2: This group was randomized into a 2-way crossover design in which they received 7 days administration of Zegerid OTC Capsules and Prilosec OTC Tablets, respectively. As with the prior group, there was a minimum of a 2-week washout period between treatment legs. Participants assigned to this treatment group underwent 24-hour intragastric pH recordings on the days which they received their 1st and last (7th) dose of the two treatment drugs. In addition to the above detailed procedures, all participants (both groups) underwent a 24-hour baseline intragastric pH study prior to starting their randomized treatments. This study design enabled all 60 participants to be evaluated for effects of the first dose of Prilosec OTC Tablets and Zegerid OTC Capsules on change in intragastric pH during the subsequent 24-hour period following the first dose.

Gastric Acid Human Experimentation

null

2

arm 1: Omeprazole 20 mg /sodium bicarbonate 1100 mg over-the-counter (OTC) Capsule arm 2: Omeprazole magnesium 20 mg OTC tablet

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Single dose of omeprazole/sodium bicarbonate per day for either 1 or 7 days. intervention 2: Single dose of omeprazole magnesium per day for either 1 or 7 days.

intervention 1: Omeprazole/sodium bicarbonate intervention 2: omeprazole magnesium (20 mg equivalent)

0

null

0

NCT00765206

[ 0 ]

223

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

To compare flavocoxid with naproxen for patients with moderate to severe osteoarthritis of the knee.

Efficacy of flavocoxid 500 mg compared with naproxen 500 mg in subjects with moderate-severe osteoarthritis of the knee.

Osteoarthritis of Knee

null

2

arm 1: flavonoid mixture arm 2: nonsteroidal anti-inflammatory drug

[ 0, 1 ]

2

[ 7, 0 ]

intervention 1: medical food intervention 2: antiinflammatory drug

intervention 1: flavocoxid intervention 2: Naproxen

0

null

0

NCT00790985

[ 5 ]

169

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

The objectives of this clinical trial are to compare the quality of life of the subjects, the efficacy and the tolerance of Duac® Gel (gel formulation with a combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide), applied once daily, against Differin® Gel (gel with 0.1% adapalene), used once daily, in the treatment of mild to moderate acne vulgaris.

Acne vulgaris is a chronic inflammatory disease of the pilosebaceous unit. It is characterized by the formation of comedones, papules, pustules, nodules, cysts, maculae and scars, generally located on the face, chest and back. Acne pathogenesis is recognized as multifactorial. Acne vulgaris is the most common dermatological disorder. It affects approximately 85% individuals at some point in their lives, generally between 12 and 24 years of age. Although acne is prevalent within this age range, it can persist for many years and its long-term physical and psychological implications can be significant. There are several medicinal products used to treat acne. However, the therapeutic challenge remains, therefore it is essential to continue investigating effective strategies for the treatment of this disease.

Acne Vulgaris

Differin quality of life Acne Duac Acne Vulgaris

null

2

arm 1: Duac Gel arm 2: Differin gel

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Duac® Gel will be applied to the face once daily at night, for 12 weeks. intervention 2: Differin Gel will be applied to the face once daily at night, for 12 weeks.

intervention 1: Duac Gel intervention 2: Differin gel

8

A Coruña | N/A | Spain | -8.396 | 43.37135 Badalona | N/A | Spain | 2.24741 | 41.45004 Barcelona | N/A | Spain | 2.15899 | 41.38879 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Málaga | N/A | Spain | -4.42034 | 36.72016 Pamplona | N/A | Spain | -1.64323 | 42.81687 Salamanca | N/A | Spain | -5.66388 | 40.96882

0

NCT00807014

[ 0 ]

10

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This is a four week open label trial of ALLOPURINOL to the treatment regime of ten (10) poorly responsive patients with schizophrenia, monitoring their response and side-effects. No change in medication is required.

null

Schizophrenia

null

1

arm 1: Allopurinal 300mg once daily by mouth for four weeks

[ 0 ]

1

[ 0 ]

intervention 1: 300mg once daily by mouth for four weeks

intervention 1: Allopurinal

0

null

0

NCT00823199

[ 5 ]

33

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin vs. Benzoyl peroxide used in combination with clindamycin and doxycycline in the treatment of moderate acne

To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin vs. Benzoyl peroxide used in combination with clindamycin and doxycycline once daily in the treatment of moderate acne

Acne

null

2

arm 1: Benzoyl peroxide (BPO) wash with clindamycin foam arm 2: Benzoyl peroxide (BPO) wash with clindamycin foam and doxycycline capsules

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Benzoyl peroxide wash - Clindamycin foam intervention 2: Benzoyl peroxide wash - Clindamycin foam - Doxycycline capsules

intervention 1: Benzoyl peroxide with clindamycin intervention 2: Benzoyl peroxide with clindamycin and doxycycline

2

0

NCT00837213

[ 0 ]

10

RANDOMIZED

SINGLE_GROUP

0TREATMENT

2DOUBLE

true

0ALL

true

This study is a split face, paired-comparison, pilot study of at least 10 subjects to complete. Participants in this study will be patients seen at Children's Memorial Hospital, who are clinically diagnosed with mild to moderate acne vulgaris. Participants will be recruited from one of the clinics, as well as from previous Institutional Review Board (IRB) approved acne studies housed in the Department of Dermatology. All subjects accrued from previous studies have agreed to be contacted for further investigations. Subjects 13 to 35 years of age with mild to moderate acne vulgaris symmetrical in appearance on both sides of the face, and meeting inclusion criteria will be eligible to participate

Acne vulgaris is a follicular disorder occurring in pilosebaceous units in the skin of the face, neck, and upper trunk. These sebaceous follicles have follicular channels and adjacent multiacinar sebaceous glands. In the lubrication process of normal skin, sebum travels through the follicular canal to the skin surface, carrying along with it desquamated cells from follicular epithelium. Acne develops when these specialized follicles undergo pathologic alterations that result in the formation of non-inflammatory lesions (comedones) and inflammatory lesions (papules, pustules, and nodules)1. The basic cause of acne remains unknown, but its manifestations are thought to be the product of four pathogenic events: 1) increased sebum production fueled by androgenic stimulation in the pubertal period; 2) obstruction of the pilosebaceous unit due to an abnormal keratinization process; 3) proliferation of Propionibacterium acnes, an anaerobic diphtheroid normally residing in pilosebaceous follicles; and 4) inflammation that is mediated both by the action of chemotactic factors and various enzymes, and initiated in part by the interaction of P. acnes with toll-like receptors. Impaction of the pilosebaceous follicle gives rise to the microcomedo that is thought to be the precursor lesion of acne1. Topical salicylic acid is a common and well-established agent with known keratolytic properties used in the treatment of acne vulgaris. The safety profile for topical salicylic acid has been well delineated. The most common side effects attributed to salicylic acid products include irritation, dryness, scaling, burning and stinging. Salicylic acid 1.0% creams (Formulation A and Formulation B) will be evaluated to detect any differences in their response for safety and efficacy.

Acne Vulgaris

Acne

null

1

arm 1: None

[ 0 ]

2

[ 0, 0 ]

intervention 1: Formulation A will be applied to the randomly-assigned single (left or right) side of the face twice daily. intervention 2: Formulation B will be applied to the randomly-assigned single (left or right) side of the face twice daily.

intervention 1: Formulation A intervention 2: Formulation B

1

Chicago | Illinois | United States | -87.65005 | 41.85003

0

NCT00848744

[ 5 ]

49

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

0ALL

false

The purpose of this study is to compare the anti-inflammatory efficacy of a dentifrice

null

Gingivitis

null

2

arm 1: Triclosan/Copolymer/fluoride toothpaste arm 2: sodium monofluorophosphate toothpaste

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Twice daily usage intervention 2: Twice daily usage

intervention 1: Triclosan/Copolymer/fluoride toothpaste intervention 2: sodium monofluorophosphate toothpaste

1

Chapel Hill | North Carolina | United States | -79.05584 | 35.9132

0

NCT00941668

[ 5 ]

217

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to compare the treatment effects of rabeprazole and lansoprazole depending on the genotyping (process of determining the genetic constitution) of CYP2C19 in treating reflux esophagitis (caused by gastroesophageal reflux; deterioration of the protective lining on the inner wall of the lower esophagus); and to evaluate the cure rate of reflux esophagitis on endoscopy (a thin flexible tube with a microscopic camera at the end which is passed down your throat into the esophagus, stomach, and duodenum) after treatment with rabeprazole and lansoprazole.

This is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), multi-center (conducted in more than 1 center), randomized (study drug assigned by chance) study in participants with reflux esophagitis. The study will include 4 visits: Visit 1 (Screening period of up to 14 days), Visit 2 (Day 1), Visit 3 (Day 29+3), and Visit 4 (Day 56). After Screening, eligible participants will be analyzed on Visit 2 (Day 1) for symptoms during past week, At visit 3 (Day 29+3) participants will be randomly assigned to 1 of the 2 treatment groups: rabeprazole 20 milligram (mg) or lansoprazole 30 mg group. Participants will receive rabeprazole 20 mg tablet orally once daily for 28 to 56 days or lansoprazole 30 mg capsule orally once daily for 28 to 56 days. A post-study follow-up visit will be conducted only if participant will be affected by any serious adverse event within 30 days after the completion of study drug. Participants will primarily be assessed for the cure rate of reflux esophagitis based on endoscopy of 2 groups. Participants' safety will be monitored throughout the study.

Reflux Esophagitis

Reflux esophagitis Rabeprazole Lansoprazole

null

2

arm 1: Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days. arm 2: Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days. intervention 2: Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days.

intervention 1: Rabeprazole intervention 2: Lansoprazole

0

null

0

NCT01008696

[ 2 ]

18

RANDOMIZED

CROSSOVER

9OTHER

0NONE

true

0ALL

false

This study conducted in healthy male and female adult participants compared the bioavailability and relative safety and tolerance of a single dose of ondansetron 8 mg Orally Dissolving Filmstrip (ODFS) administered under fasting conditions with and without water with that of a single dose of Zofran Orally Dissolving Tablets (ODT®) containing ondansetron 8 mg administered under fasting conditions without water.

This was an open-label, single oral dose,randomized sequence, three-way crossover study to compare the bioavailability, safety and tolerability of ondansetron 8 mg Orally Dissolving Filmstrip (ODFS) administered without (Test Treatment A) and with water (Test Treatment B) with that of Zofran Orally Dissolving Tablets (ODT®) containing ondansetron 8 mg administered without water (Reference Treatment C) in healthy adult participants. The 3 treatment sequences were: ABC, BCA, and CAB, in which, all treatments were administered after an overnight fasting of at least 10 hours in each period. Participants reported to the study site between 07:30 am to 04:30 pm on 22 Aug 2008, 25 Aug 2008, and 28 Aug 2008 for Period 1, Period 2, \& Period 3, respectively. Participants were served dinner between 8:00 pm to 8:30 pm, to ensure a minimum of 10 hours of fasting prior to administration of a single dose of either the test or reference product. Participants were dosed as per the randomization schedule with a 3-day wash out period between each administration. A total of 18 blood samples (4 mL each) were collected from each subject in each period for pharmacokinetic analyses. Safety assessments including monitoring of adverse events, periodic physical examination, and vital signs monitoring. Urine Drug Screening was done at the time of check-in of all the study periods to identify participants with any substance abuse. Urine pregnancy screen (for female subjects only) was scheduled at the time of screening and at admission for Period 1, Period 2, Period 3. A clinical assessment, which included general and systemic examination, was done at the pre-study screening and post study physical examination. Clinical laboratory hematology and chemistry tests were performed at screening (pre-study) and at the study follow-up visit (post-study).

Healthy Participants

bioavailability

null

3

arm 1: Six subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water). Each dose was administered following a 10-hour fast with a 3-day washout period between doses. arm 2: Six subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water). Each dose was administered following a 10-hour fast with a 3-day washout period between doses. arm 3: Six subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water). Each dose was administered following a 10-hour fast with a 3-day washout period between doses.

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Single dose of Ondansetron 8 mg (ODFS) administered without water intervention 2: Single dose of Ondansetron 8 mg (ODSF) was orally administered, allowed to dissolve, swallowed with saliva, followed with water intervention 3: Single dose of Zofran ODT (containing ondansetron 8 mg) administered without water

intervention 1: Ondansetron 8 mg ODFS without water intervention 2: Ondansetron 8 mg ODFS with water intervention 3: Zofran ODT (ondansetron 8 mg) without water

0

null

0

NCT01220167

[ 2 ]

21

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

This study in patients with schizophrenia is designed to provide preliminary evidence of the safety, tolerability, and pharmacokinetics as well as the effects on cognitive function of 2 doses of EVP-6124 compared with placebo when given with the patient's usual antipsychotic medication.

Study drug will be supplied as capsules and will be orally administered once daily for a total of 21 days. Eligible subjects will be admitted to an inpatient study unit on Day -6 (six days before the first dose of study drug is administered) and will remain confined to the inpatient study unit throughout the dosing phase. Safety assessments, PK sampling, and cognitive testing will be performed.

Schizophrenia Schizoaffective Disorder Central Nervous System Diseases

Schizophrenia Schizoaffective CNS

null

3

arm 1: Matching placebo was administered as one capsule per day for 21 days. arm 2: EVP-6124 was administered as one 1.0 mg capsule per day for 21 days. arm 3: EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.

[ 2, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: EVP-6124 was administered as one 0.3 mg capsule per day for 21 days. intervention 2: EVP-6124 was administered as one 1.0 mg capsule per day for 21 days. intervention 3: Matching placebo was administered as one capsule per day for 21 days. intervention 4: Concomitant therapy with antipsychotic medication (aripiprazole \[10 to 30 mg/day\], olanzapine \[10 to 20 mg/day\], paliperidone \[3 to 12 mg/day\], or risperidone \[2 to 16 mg/day\]), taken at the same time each day as the EVP-6124 dose. Patients must have been taking concomitant therapy for at least 2 weeks at a stable dose to be eligible for the study.

intervention 1: EVP-6124 (0.3 mg/day) intervention 2: EVP-6124 (1.0 mg/day) intervention 3: Placebo intervention 4: Antipsychotic therapy

1

Wichita | Kansas | United States | -97.33754 | 37.69224

0

NCT01556763

[ 2 ]

20

NON_RANDOMIZED

PARALLEL

2DIAGNOSTIC

1SINGLE

true

0ALL

false

This study will test two different doses of florbetapir F 18 to determine which dose is best to image amyloid plaques in the brains of Alzheimer's Disease (AD) patients using a positron emission tomography (PET) scanner.

null

Alzheimer Disease

Amyloid imaging Positron Emission Tomography 18F-AV-45 florbetapir F 18 Diagnostic imaging

null

4

arm 1: Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel arm 2: Healthy controls who received 111MBq (3 mCi) of florbetapir F 18 arm 3: Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18 arm 4: Healthy controls who received 370MBq (10 mCi) of florbetapir F 18.

[ 0, 0, 0, 0 ]

1

[ 0 ]

intervention 1: single dose IV injection

intervention 1: florbetapir F 18

3

0

NCT01565330