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

[ 4 ]

434

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

This study uses a randomized, double-blind, controlled design to demonstrate that PN400 (esomeprazole and naproxen) is more effective in reducing the occurrence of gastroduodenal ulcers, dyspepsia, and heartburn in subjects at risk for developing NSAID-associated gastric ulcers compared to naproxen alone.

Objectives: Primary: To demonstrate that PN400 is effective in reducing the risk of gastric ulcers in subjects at risk for developing NSAID-associated gastric ulcers. Secondary: * To determine if PN400 is effective in reducing the risk of duodenal ulcers in subjects at risk for developing NSAID-associated ulcers * To compare upper gastrointestinal symptoms in subjects treated with PN400 versus naproxen as measured by scores on the Severity of Dyspepsia Assessment (SODA) instrument and the Overall Treatment Evaluation - Dyspepsia (OTE-DP) * To compare heartburn symptoms in subjects treated with PN400 versus naproxen * To evaluate the safety and tolerability of PN400 and naproxen

Gastric Ulcer

NSAID gastric ulcers Vimovo Naproxen Esomeprazole

null

2

arm 1: Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily arm 2: Naproxen 500 mg dosed twice daily

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: PN400 tablets (Naproxen 500 mg and Esomeprazole 20 mg) twice daily (bid) taken orally. intervention 2: Naproxen (500 mg) dosed twice daily (bid) orally

intervention 1: PN400 (VIMOVO) intervention 2: Naproxen

1

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

0

NCT00527787

[ 3 ]

160

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

The purpose of this study is to determine if the combination of enzastaurin and pemetrexed can extend survival time without progression of disease for participants who have advanced or metastatic non-small cell lung cancer (NSCLC).

null

Non-small Cell Lung Cancer

null

2

arm 1: None arm 2: None

[ 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: 1125 milligrams (mg) loading dose then 500 mg, oral, daily Cycle 1 (28 days), subsequent cycles 21 days, until disease progression intervention 2: oral, daily intervention 3: 500 milligrams per square meter (mg/m\^2), intravenous (IV), day 8 Cycle 1 (28 days), day 1 subsequent cycles (21 days), until disease progression

intervention 1: enzastaurin intervention 2: placebo intervention 3: pemetrexed

25

Fayetteville | Arkansas | United States | -94.15743 | 36.06258 Lancaster | California | United States | -118.13674 | 34.69804 Los Angeles | California | United States | -118.24368 | 34.05223 Tampa | Florida | United States | -82.45843 | 27.94752 Wichita | Kansas | United States | -97.33754 | 37.69224 Scarborough | Maine | United States | -70.32172 | 43.57814 Dayton | Ohio | United States | -84.19161 | 39.75895 Memphis | Tennessee | United States | -90.04898 | 35.14953 Fort Worth | Texas | United States | -97.32085 | 32.72541 Richardson | Texas | United States | -96.72972 | 32.94818 Grenoble | N/A | France | 5.71479 | 45.17869 Marseille | N/A | France | 5.38107 | 43.29695 Saint-Herblain | N/A | France | -1.651 | 47.21154 Toulouse | N/A | France | 1.44367 | 43.60426 Villejuif | N/A | France | 2.35992 | 48.7939 Cologne | N/A | Germany | 6.95 | 50.93333 Gauting | N/A | Germany | 11.37703 | 48.06919 Großhansdorf | N/A | Germany | 10.28333 | 53.66667 Aviano | N/A | Italy | 12.59472 | 46.07056 Genova | N/A | Italy | 11.87211 | 45.21604 Orbassano | N/A | Italy | 7.53813 | 45.00547 Coimbra | N/A | Portugal | -8.41955 | 40.20564 Lisbon | N/A | Portugal | -9.1498 | 38.72509 Porto | N/A | Portugal | -8.61099 | 41.14961 Seoul | N/A | South Korea | 126.9784 | 37.566

0

NCT00530621

[ 4 ]

677

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

null

This single arm study will assess participant preference for monthly Bonviva, versus daily or weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis. Participants currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or risedronate) will answer a questionnaire to identify participants who may benefit from a monthly Bonviva regimen. Eligible participants will then discontinue their present bisphosphonate treatment, and switch to monthly Bonviva 150mg per oral (po). At the beginning and end of Bonviva treatment, all participants will complete an Osteoporosis Patient Satisfaction Questionnaire. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

null

Post-Menopausal Osteoporosis

null

1

arm 1: Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.

[ 0 ]

1

[ 0 ]

intervention 1: 150 mg orally once monthly for 6 months

intervention 1: Ibandronate

32

Tirana | N/A | Albania | 19.81866 | 41.32744 Banja Luka | N/A | Bosnia and Herzegovina | 17.19386 | 44.77842 Sarajevo | N/A | Bosnia and Herzegovina | 18.35644 | 43.84864 Sarajevo | N/A | Bosnia and Herzegovina | 18.35644 | 43.84864 Tuzla | N/A | Bosnia and Herzegovina | 18.66709 | 44.53842 Rijeka | N/A | Croatia | 14.44241 | 45.32673 Slavonski Brod | N/A | Croatia | 18.01556 | 45.16028 Split | N/A | Croatia | 16.43915 | 43.50891 Zagreb | N/A | Croatia | 15.97798 | 45.81444 Skopje | N/A | North Macedonia | 21.43141 | 41.99646 Belgrade | N/A | Serbia | 20.46513 | 44.80401 Niška Banja | N/A | Serbia | 22.0057 | 43.29507 Novi Sad | N/A | Serbia | 19.83694 | 45.25167 Adana | N/A | Turkey (Türkiye) | 35.32531 | 36.98615 Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987 Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987 Antalya | N/A | Turkey (Türkiye) | 30.69556 | 36.90812 Aydin | N/A | Turkey (Türkiye) | 27.83963 | 37.84501 Bursa | N/A | Turkey (Türkiye) | 29.06013 | 40.19559 Denizli | N/A | Turkey (Türkiye) | 29.0875 | 37.77417 Erzurum | N/A | Turkey (Türkiye) | 41.27694 | 39.90861 Gaziantep | N/A | Turkey (Türkiye) | 37.3825 | 37.05944 Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384 Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384 Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384 Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384 Izmir | N/A | Turkey (Türkiye) | 27.13838 | 38.41273 Kayseri | N/A | Turkey (Türkiye) | 35.48528 | 38.73222 Konya | N/A | Turkey (Türkiye) | 32.48464 | 37.87135 Manisa | N/A | Turkey (Türkiye) | 27.42647 | 38.61202 Samsun | N/A | Turkey (Türkiye) | 36.3361 | 41.27976 Trabzon | N/A | Turkey (Türkiye) | 39.72694 | 41.005

0

NCT00545779

[ 5 ]

12

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This study is designed to determine if different doses of buprenorphine (either tapering doses or steady doses) are effective in managing chronic, non-cancer pain in individuals who also are addicted to opiate pain medicines.

Context: Some individuals have two conditions: 1) a well-documented pain disorder and 2) clear evidence of a substance use disorder with opiate dependency. It is not known how to manage these patients. In addition to other modalities for the treatment of chronic pain, combination tablets of buprenorphine/naloxone (Suboxone) may be helpful. Objective: The objective of this study is to determine if the addition of pharmacotherapy with Suboxone to usual care would improve clinical outcome relative to usual care alone. Design: Randomized control trial. Setting: The study will be conducted in the out-patient clinics of a tertiary-care teaching hospital. Participants: The participants will be those who have: 1) a well-documented pain disorder and 2) clear evidence of a substance use disorder with opiate dependency. Baseline data collected: Data collected at baseline will include (with examples): demographics (age, gender, race), substance use history (type of substances used, duration of use, routes of abuse), type of pain disorder (previous traumatic injury, musculoskeletal, neuropathic), co-existing medical problems (seizures, hepatitis C), prior injuries (accidents, interpersonal violence), prior mental health problems (prior treatment, diagnoses), prior substance abuse treatment (outpatient, inpatient), socioeconomic variables (educational level, occupation, employment history), criminal history (number of arrests and convictions, total amount of time spent in jail or prison), family history (first degree relatives with substance use disorders) and scores on psychometric testing (ASI). Outcome data: Three main outcome variables will be examined relapse to substance use (as documented by toxicology), quality of life, and successful participation in the pain management program for six months, which included the completion of the study buprenorphine treatment protocols. Data analyses: Outcome variables will be compared between the two groups using t-tests or chi-square tests as appropriate. A Kaplan-Myer survival analysis will be used to describe participant participation. Predictors of poor outcomes will be identified using a case-control design in which those with poor outcomes (the "cases") will be compared to those with successful outcomes (the "controls") using multivariate techniques (logistic regression).

Opiate Addiction Refractory Pain

drug dependence substance abuse substance use disorders myofascial pain syndrome neuralgia back pain

null

2

arm 1: Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification. arm 2: Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: sublingual tablets, 2/0.5 mg, three times a day for one month, twice a day for one month, once a day for one month, then every other day for one month. (dose may be adjusted based on an individual's response) intervention 2: sublingual tablets, 2/0.5 mg, one tablet three times a day for six months (doses may be adjusted based on an individual's response

intervention 1: buprenorphine/naloxone intervention 2: buprenorphine/naloxone

1

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

0

NCT00552578

[ 5 ]

451

NON_RANDOMIZED

SINGLE_GROUP

1PREVENTION

0NONE

false

0ALL

false

Fondaparinux is an antithrombotic agent having already received a regulatory approval by the European Authorities in venous thromboembolic event prevention after major orthopaedic surgery, as total hip replacement (THR), total knee replacement (TKR), hip fracture (HF). The bleeding risk associated with this prescription is highly related to renal function evaluated by creatinin clearance (CrCl). In order to reduce the bleeding risk, it has been proposed to prescribe fondaparinux 1.5 mg/day in patients with a CrCl between 20 and 50ml/mn instead of 2.5mg/day (European MMA). In the meantime, this approval is essentially based on simulated pharmakinetic data without any support of clinical data. prospective, multicentre, open-label study evaluating the safety profile of fondaparinux 1.5 mg/day, subcutaneously administered, in patients with a renal impairment defined by a CrCl between 20 and 30 ml/min and undergoing a major orthopaedic surgery.

Fondaparinux 1.5mg/day subcutaneously administered during post-surgery 1 to 10 days with the 1st treatment administration performed 6 to 8 hours after the end of surgery. Screening visit : \> 7 days before inclusion visit if THR and TKR Inclusion visit : day of surgery Visits with blood drawing: 3 visits scheduled during 1 to 10 days of treatment period Study end of treatment visit: D1 to D10 Study end visit: 1 month ± 15 days

Major Orthopaedic Surgery and Renal Impairment

major orthopaedic surgery venous thromboembolic events prevention renal impairment Arixtra anti-Xa activity

null

1

arm 1: patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery

[ 0 ]

1

[ 0 ]

intervention 1: Subcutaneous injection of fondaparinux 1.5 mg/l after major orthopaedic surgery

intervention 1: fondaparinux 1.5 mg/day

29

Agen | N/A | France | 0.62055 | 44.20199 Annonay | N/A | France | 4.6707 | 45.23992 Bayonne | N/A | France | -1.473 | 43.49316 Bobigny | N/A | France | 2.45012 | 48.90982 Bordeaux | N/A | France | -0.5805 | 44.84044 Caen | N/A | France | -0.35912 | 49.18585 Clamart | N/A | France | 2.26692 | 48.80299 Clermont-Ferrand | N/A | France | 3.08682 | 45.77969 Dijon | N/A | France | 5.01667 | 47.31667 La Roche-sur-Yon | N/A | France | -1.42757 | 46.66974 Le Mans | N/A | France | 0.20251 | 48.0021 Lyon | N/A | France | 4.84671 | 45.74846 Lyon | N/A | France | 4.84671 | 45.74846 Montpellier | N/A | France | 3.87635 | 43.61093 Nantes | N/A | France | -1.55336 | 47.21725 Nice | N/A | France | 7.26608 | 43.70313 Niort | N/A | France | -0.45877 | 46.32313 Nîmes | N/A | France | 4.35788 | 43.83665 Paris | N/A | France | 2.3488 | 48.85341 Paris | N/A | France | 2.3488 | 48.85341 Paris | N/A | France | 2.3488 | 48.85341 Poitiers | N/A | France | 0.34348 | 46.58261 Reims | N/A | France | 4.02853 | 49.26526 Rouen | N/A | France | 1.09932 | 49.44313 Saint-Etienne | N/A | France | 4.39 | 45.43389 Saint-Etienne | N/A | France | 4.39 | 45.43389 Saint-Saulve | N/A | France | 3.55612 | 50.37141 Toulouse | N/A | France | 1.44367 | 43.60426 Tours | N/A | France | 0.70398 | 47.39484

0

NCT00555438

[ 0 ]

20

RANDOMIZED

PARALLEL

9OTHER

0NONE

false

0ALL

false

The purpose of this study is to evaluate the efficacy of Blink Tears and Systane used concomitantly with topical cyclosporine for the treatment of dry eye.

Dry eye is a chronic condition that is believed to afflict more than 3 million patients in the United States.1 Symptoms of dry eye are very bothersome and impact quality of life, reduce work capacity, and may result in poorer psychological health. Also, symptoms of dry eye are associated with a decreased ability to perform activities that require visual attention such as reading and driving a car.2 Patients with dry eye complain most frequently of a scratchy or sandy (foreign body) sensation. Other common symptoms are itching, excessive mucus secretion, inability to produce tears, a burning sensation, photosensitivity, redness, pain, and difficulty in moving the lids. In most patients, the most remarkable feature of the eye examination is the grossly normal appearance of the eye.3 Chronic dry eye disease is associated with an inflammatory mechanism mediated by activated T-cell lymphocytes3 which affects the ocular surface and lacrimal gland.4 The damage caused by dry eye disease may be irreversible, and despite the availability of various tear substitutes, many patients with dry eye syndrome experience corneal injuries with a subsequent reduction in vision.5 Cyclosporin A (Restasis®, Allergan, Irvine, CA) has been shown to significantly reduce the number of activated T-lymphocytes within the conjunctiva6, thereby minimizing the inflammation causing dry eye. Topical cyclosporin A 0.05% ophthalmic emulsion (Restasis®, Allergan, Irvine, CA) increases tear production and improves the quality of naturally produced tears and is the first approved therapeutic agent for the treatment of chronic dry eye and the only treatment modality that addresses the underlying pathology. In addition to topical therapy with cyclosporine, some patients continue to use artificial tears for occasional relief of residual symptoms. The choice of concomitant tear is important but little research has been published differentiating between the efficacy of these solutions when used concomitantly with topical cyclosporine.

Dry Eye Syndrome

Treatment Dry Eye

null

2

arm 1: None arm 2: None

[ 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: None intervention 2: blink tears to be used twice a day intervention 3: systane to be used twice a day

intervention 1: Cyclosporin A Restasis® intervention 2: Blink tears intervention 3: Systane

1

Charleston | South Carolina | United States | -79.93275 | 32.77632

0

NCT00565669

[ 5 ]

37

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

0NONE

true

0ALL

false

The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears of healthy volunteers

null

Bacterial Infections Eye Infections

null

2

arm 1: None arm 2: None

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: One drop ophthalmic solution at Visit 2 intervention 2: One drop ophthalmic solution at Visit 2

intervention 1: AzaSite (azithromycin ophthalmic solution) intervention 2: Vigamox (moxifloxacin hydrochloride ophthalmic solution)

1

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

0

NCT00575367

[ 3 ]

28

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

Concurrent dependence on cocaine occurs in up to 50% of the over one million opiate dependent patients in spite of methadone maintenance treatment being highly effective for opiate dependence and having excellent treatment retention. Cocaine dependence has remained largely unresponsive to medications both in and outside of these methadone programs. We have initial data from our open-label study with levetiracetam showing that this medication is well tolerated and may reduce cocaine use in this cocaine-abusing methadone treated population. The specific aim of this study is to evaluate the efficacy of levetiracetam 3 grams/day in modifying cocaine-using behavior, reducing cocaine craving and attenuating cocaine's reinforcing effect among methadone-maintained patients. The primary outcomes will be reduction in cocaine use as assessed by self-report and thrice-weekly urinalyses. Secondary outcomes will include weeks in treatment (retention) and change in measures of cocaine craving, anxiety symptoms and opiate withdrawal symptoms.

This 17-week double-blind, placebo controlled randomized pilot clinical trial will provide treatment for 40 cocaine-dependent opioid dependent patients. Participants, aged 18-65 years, will be randomized to receive levetiracetam 3000 mg/day or placebo while concurrently receiving treatment with methadone. Baseline cocaine use will be determined during the first week of treatment participation. (Gossop et al., 1997) The study design will have three overlapping phases that are summarized below: 1) A one week methadone fixed induction (week 1) and flexible methadone stabilization phase (weeks 2-13); 2) an 12-week "treatment" phase (weeks 2-13), consisting of slow titration and stabilization on study medication; and 3) a four week "taper, detoxification or transfer" phase (weeks 13-17). During the first week of induction onto methadone, participants will be administered increasing doses of methadone starting at 30 mg daily and increased up to 60 mg daily by the end of the first week. This methadone dose will be adjusted for stabilization of opiate withdrawal symptoms using a flexible dosing from 40 mg up to 150 mg between weeks 2 to 12. This range has been found to be adequate for the vast majority of patients receiving methadone in our program and is designed to accommodate participants who may not be able to tolerate the higher maintenance doses or may still experience withdrawal symptoms, respectively. We may increase or decrease this amount on a case-by-case basis based on physician assessment of self-reported and observed symptoms. Starting on week 2 subjects will start study medication in one of two randomly assigned experimental groups: levetiracetam 3000 mg /day (active medication) or placebo (inactive medication). Concurrent with the stabilization on methadone, levetiracetam will be increased from 500mg/day on week 2 and this dose will be slowly titrated to a total of 3000mg/day or maximum tolerated dose (MTD). Subjects will remain on their full dosage through week 13. At the end of week 13, participants will undergo detoxification from methadone over a 4-week period (weeks 13-17) and discontinuation from levetiracetam over a concurrent 2-week period. All participants will receive weekly 1-hour of individual psychotherapy (Cognitive Behavioral Treatment) with experienced clinicians specifically trained to deliver the therapy and who will receive ongoing supervision. The primary outcomes will be reduction in cocaine use, as assessed by self-report and thrice-weekly urinalyses. Secondary outcomes will include weeks in treatment (retention), reported medication side effects (medication tolerability), and change in measures of: cocaine craving, anxiety symptoms and opiate withdrawal symptoms. This study will occur at the Outpatient Treatment Research Program in Building 36 at the VA CT Healthcare System.

Cocaine Dependence Opioid Dependency

GABAergic levetiracetam

null

2

arm 1: Levetiracetam tablets arm 2: matching placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: The participants will start receiving Levetiracetam 500mg in the mornings of the first day on week 2. The dose will be titrated every third day, until the target dose of 3000mg/day is achieved by week 4. The study medication must be titrated to 3000 mg/day or to the subject's maximum tolerated dose (MTD). The physician overseeing this titration as well as all study staff will be blind to the subject's medication administration. The medication will be discontinued over a two-week period. intervention 2: None

intervention 1: levetiracetam intervention 2: Placebo

1

West Haven | Connecticut | United States | -72.94705 | 41.27065

0

NCT00577005

[ 3 ]

169

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

false

0ALL

false

Patients with knee pain due to Osteoarthritis (OA) experiencing sub-optimal pain relief from their current analgesic regimen will participate in a pilot clinical trial to evaluate the effectiveness and tolerability of the Lidoderm Patch compared with placebo in treating knee pain from OA.

null

Osteoarthritis of the Knee

Osteoarthritis Knee Lidoderm Lidocaine Topical patch Adjunct therapy

null

2

arm 1: Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) arm 2: Placebo Patch 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h)

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Topical Patch intervention 2: Topical Patch

intervention 1: Lidoderm (Lidocaine 5% Patch) intervention 2: Placebo Patch

20

0

NCT00589979

[ 2 ]

10

NA

SINGLE_GROUP

null

0NONE

false

0ALL

false

The purpose of this study is to assess the safety, pharmacokinetics and HCV(Hepatitis C virus) RNA (Ribonucleic Acid) kinetics after administration of MP-424 to patients with chronic hepatitis C.

null

Chronic Hepatitis C

Chronic Hepatitis C Protease Inhibitor

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Three tablets of MP-424 250mg tablet at a time, every 8 hours, 12 weeks administration (dose in a day: 2250 mg)

intervention 1: MP-424 (Telaprevir)

1

Kawasaki | Takatsu-ku | Japan | 139.71722 | 35.52056

0

NCT00591214

[ 0 ]

10

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine with cyclosporine alone for the prevention of graft-versus-host disease. This research is being done because there is no completely safe and effective prevention for graft-versus-host disease. It is known that cyclosporine helps with GVHD but we would like to know if the addition of basiliximab will decrease the incidence and/or severity of GVHD after a transplant known as nonmyeloablative ("mini" transplant).

null

Acute Myelogenous Leukemia Acute Lymphocytic Leukemia Chronic Myelogenous Leukemia Chronic Lymphocytic Leukemia Myelodysplasia Lymphoma, Non-Hodgkin's Mantle-Cell Lymphoma Hodgkin's Disease Multiple Myeloma Myelofibrosis

null

0

null

5

[ 0, 0, 0, 0, 0 ]

intervention 1: 60mg/kg/day for two consecutive days (-7,-6). intervention 2: 25mg/m2/day for 5 consecutive days intervention 3: 3mg/kg/day will be given by continuous intravenous infusion beginning on Day -1. intervention 4: 1000 mg will be administered through day +60 and then discontinued if there is no GVHD. intervention 5: 20mg , will be given by intravenous infusion (without an in-line filter) over at least 15 minutes beginning 3 days after engraftment.

intervention 1: Cyclophosphamide intervention 2: Fludarabine intervention 3: Cyclosporine intervention 4: Mycophenolate mofetil intervention 5: Basiliximab

1

Indianapolis | Indiana | United States | -86.15804 | 39.76838

0

NCT00594308

[ 3 ]

239

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

A Multi-Centered Randomized, Double-Blind, Placebo-Controlled, Phase 2, Exploratory Study to Evaluate the Effect of Rufinamide on Anxiety in Patients with Moderate to Severe Generalized Anxiety Disorder.

This was an exploratory study to evaluate the effect of 500 or 1000 mg per day for 8 weeks of Rufinamide compared to placebo on measures of anxiety in patients with Generalized Anxiety Disorder, and to determine tolerability of Rufinamide in this population.

Generalized Anxiety Disorder

GAD

null

2

arm 1: 500 mg 1 week, followed by 1000 mg for 7 weeks arm 2: 0 mg tablets

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 500 mg for 1 week followed by 1000 mg for 7 weeks intervention 2: 0 mg tablets

intervention 1: SYN111 intervention 2: Placebo

2

0

NCT00595231

[ 3 ]

602

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

This study will assess the safety and efficacy of 5 doses GW642444 in subjects with Chonic Obstructive Pulmonary Disease (COPD)

null

Pulmonary Disease, Chronic Obstructive

Chronic Obstructive Pulmonary Disease (COPD) COPD GW642444

null

2

arm 1: GW642444 arm 2: None

[ 1, 2 ]

6

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

intervention 1: GW642444 6.25 intervention 2: once daily intervention 3: GW642444 12.5mcg intervention 4: GW642444 25mcg intervention 5: GW642444 50mcg intervention 6: placebo

intervention 1: GW642444 6.25 intervention 2: GW642444 3mcg intervention 3: GW642444 12.5mcg intervention 4: GW642444 25mcg intervention 5: GW642444 50mcg intervention 6: placebo

99

0

NCT00606684

[ 4 ]

263

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation

HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation, loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Data from the first Phase 3 multicenter, randomized, placebo-controlled trial demonstrated that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV- infected patients with excess of abdominal fat accumulation for 26 weeks resulted in decreases in visceral adipose tissue (VAT) and trunk fat, with lesser changes in limb fat and subcutaneous adipose tissue (SAT). The present study is aimed at confirming the observations made during the first Phase 3 study.

Lipodystrophy HIV Infections

HIV Lipodystrophy Abdominal fat accumulation Growth hormone releasing hormone HIV-associated lipodystrophy Treatment experienced

null

3

arm 1: Tesamorelin 2 mg/day for 12 months arm 2: Tesamorelin 2 mg/day for 6 months - Placebo for 6 months arm 3: Placebo 6 months - Tesamorelin 2 mg/day for 6 months

[ 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Tesamorelin intervention 2: Placebo for Tesamorelin

47

0

NCT00608023

[ 3 ]

94

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate three different dosage strengths of sublingual ARX-F01 (Sufentanil NanoTab) versus a sublingual Placebo NanoTab for the treatment of post-operative pain in subjects following total knee replacement surgery. We hypothesize that subjects receiving placebo will have poor pain relief and will drop out of the study sooner and more often than the ARX-F01-treated subjects.

null

Post Operative Pain

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: 5 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours intervention 2: Placebo NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours intervention 3: 10 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours intervention 4: 15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours

intervention 1: Sufentanil NanoTab intervention 2: Placebo NanoTab intervention 3: Sufentanil NanoTab intervention 4: Sufentanil NanoTab

1

Durham | North Carolina | United States | -78.89862 | 35.99403

0

NCT00612534

[ 4 ]

179

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

false

0ALL

true

The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.

Subject who have completed the 24-week Treatment Period of Horizon Protocol HZ-CA-301 or HZ-CA-303 without developing an upper gastrointestinal ulcer and who are expected to continue to require daily administration of an NSAID for the next 6 months will receive treatment with the same study medication received while participating in HZ-CA-301 or HZ-CA-303. Study with completed results acquired from Horizon in 2024.

Osteoarthritis Rheumatoid Arthritis Chronic Low Back Pain Chronic Regional Pain Syndrome Chronic Soft Tissue Pain

null

2

arm 1: HZT-501: ibuprofen 800mg/famotidine 26.6mg arm 2: Ibuprofen 800mg

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Ibuprofen 800mg/famotidine 26.6 mg administered orally 3 times daily for 2 weeks intervention 2: Ibuprofen 800mg administered orally 3 times daily for at least 28 weeks

intervention 1: HZT-501 intervention 2: Ibuprofen

1

San Diego | California | United States | -117.16472 | 32.71571

0

NCT00613106

[ 4 ]

901

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of tapentadol (CG5503) compared with oxycodone and with placebo in subjects who have had a bunionectomy.

Patients undergoing bunionectomy often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when patients receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, and less frequently, respiratory depression. Tapentadol (CG5503), a newly synthesized drug with an immediate release (IR) formulation, also acts as a centrally acting analgesic but has a dual mode of action. The aim of this study is to investigate the effectiveness (level of pain control) and safety (side effects) of 2 dose levels of tapentadol (CG5503) IR compared to no drug (placebo) or one dose level of oxycodone (an opioid commonly used to treat post-surgical pain). This study is a randomized, double-blind (neither investigator nor patient will know which treatment is received), active- and placebo-controlled, parallel-group, multicenter study to evaluate treatment of the acute pain from bunionectomy. The study will include a blinded 72 hour inpatient (the patient will stay in the facility where the procedure is done) phase immediately following bunionectomy, during which patients will be treated with either 50- or 75-mg tapentadol (CG5503) IR, a placebo, or 10-mg oxycodone IR, and pain relief will be periodically assessed. Assessments of pain intensity (PI) and pain relief (PAR) are obtained using the numerical rating scale, and the patient global impression of change scale (PGIC) will measure overall patient status. Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. Venous blood samples will be collected for the determination of serum concentrations of tapentadol (CG5503) and oxycodone. The study hypotheses are that at least one tapentadol (CG5503) IR dose will be different from placebo in controlling patients pain at 48 hours, followed by establishing that at least one tapentadol (CG5503) IR dose will be non-inferior compared with oxycodone IR (oxycodone IR is not clinically significantly better than a tapentadol (CG5503) IR dose). A comparison of the incidence rate of the adverse events of nausea and/or vomiting, and the incidence rate of the adverse event of constipation, between tapentadol (CG5503) IR and oxycodone IR will also be performed. Tapentadol (CG5503) IR 50 or 75 mg, or oxycodone 10 mg, or placebo, 1 capsule taken by mouth every 4 to 6 hours during the 72-hour postsurgery phase of the study (acetaminophen is also allowed during the first 12 hours on Day 1, if needed for pain). All doses of study treatment will be taken with approximately 120 mL of water with or without food.

Arthralgia Bunion Hallux Valgus Pain

Acute pain bunionectomy tapentadol

null

4

arm 1: placebo 1 capsule q4-6 hrs for 3 days arm 2: oxycodone 10mg capsule q4-6 hrs for 3 days arm 3: Tapentadol (CG5503) 50mg capsule q4-6 hrs for 3 days arm 4: Tapentadol (CG5503) 75mg capsule q4-6 hrs for 3 days

[ 2, 1, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 50mg capsule q4-6 hrs for 3 days intervention 2: 75mg capsule q4-6 hrs for 3 days intervention 3: 10mg capsule q4-6 hrs for 3 days intervention 4: 1 capsule q4-6 hrs for 3 days

intervention 1: Tapentadol (CG5503) intervention 2: Tapentadol (CG5503) intervention 3: oxycodone intervention 4: placebo

7

0

NCT00613938

[ 2, 3 ]

85

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

To evaluate the safety and potential efficacy of deoxycholic acid injection compared to placebo for the reduction of submental fat (fat below the chin).

The trial included an initial cohort (3 participants in each arm) to evaluate safety followed by expansion to a second, larger cohort if adequate safety was determined in the initial cohort. Data from both cohorts was pooled for analysis.

Moderate or Severe Submental Fullness

null

4

arm 1: Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 2: Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 3: Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 4: Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

[ 0, 0, 0, 2 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Deoxycholic Acid Injection intervention 2: Placebo

6

Carina Heights | N/A | Australia | 153.09126 | -27.50721 Gold Coast | N/A | Australia | 153.43088 | -28.00029 Toorak | N/A | Australia | 145.01438 | -37.84165 Oakville | Ontario | Canada | -79.68292 | 43.45011 Niagara Falls | N/A | Canada | -79.06627 | 43.10012 London | N/A | United Kingdom | -0.12574 | 51.50853

0

NCT00618722

[ 2 ]

25

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

true

1FEMALE

false

Dose escalating study of 7 daily doses of Proellex at 100 mg, 150 mg and 200 mg

This is an open-label, single-center, outpatient, unblinded, multi-dose study of the safety and pharmacokinetic properties of Proellex®. Six female subjects will each receive seven daily doses of Proellex® in separate, rising doses. Dosing must be accomplished between menstrual periods. The first six women will complete the 100 mg visit schedule before the next six women will begin the 150 mg visit schedule. Blood will be collected at pre-dose, and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24 and 36 (Day 7 only) hrs post-dose on Day 1 and Day 7. Subjects will be allowed to leave the clinic between the 12 and 24 hr and the 24 and 36 hr PK blood draws. Subjects will be discharged from the study after a one month follow-up visit. Safety will be assessed throughout the study.

Healthy

Pharmacokinetics

null

3

arm 1: Proellex 100 mg daily for 7 days arm 2: Proellex 150 mg daily for 7 days arm 3: Proellex 200 mg daily for 7 days

[ 0, 0, 0 ]

1

[ 0 ]

intervention 1: Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days

intervention 1: Proellex

1

San Antonio | Texas | United States | -98.49363 | 29.42412

0

NCT00619385

[ 3 ]

128

RANDOMIZED

PARALLEL

1PREVENTION

0NONE

false

0ALL

true

The purpose of this study is to assess the safety and tolerability of AZD0837 in patients with atrial fibrillation who are unable or unwilling to take vitamin K antagonist therapy for up to 3 months.

null

Persistent or Permanent Non-valvular Atrial Fibrillation

null

0

null

2

[ 0, 0 ]

intervention 1: ER formulation intervention 2: Oral form

intervention 1: AZD0837 intervention 2: Aspirin

38

Aalborg | N/A | Denmark | 9.9187 | 57.048 Arhus N | N/A | Denmark | N/A | N/A Copenhagen | N/A | Denmark | 12.56553 | 55.67594 Esbjerg | N/A | Denmark | 8.45187 | 55.47028 Frederikssund | N/A | Denmark | 12.06896 | 55.83956 Horsens | N/A | Denmark | 9.85034 | 55.86066 Silkeborg | N/A | Denmark | 9.54508 | 56.1697 Svendborg | N/A | Denmark | 10.60677 | 55.05982 Elverum | N/A | Norway | 11.56231 | 60.88191 Gjettum | N/A | Norway | 10.52911 | 59.90607 Kongsberg | N/A | Norway | 9.65017 | 59.66858 Oslo | N/A | Norway | 10.74609 | 59.91273 Stovner | N/A | Norway | 10.93174 | 59.95613 Straume | N/A | Norway | 14.47205 | 68.6888 Bytom | N/A | Poland | 18.93282 | 50.34802 Częstochowa | N/A | Poland | 19.12409 | 50.79646 Krakow | N/A | Poland | 19.93658 | 50.06143 Lodz | N/A | Poland | 19.47395 | 51.77058 Lublin | N/A | Poland | 22.56667 | 51.25 Ostrów Mazowiecka | N/A | Poland | 21.89507 | 52.80245 Otwock | N/A | Poland | 21.26129 | 52.10577 Płock | N/A | Poland | 19.70638 | 52.54682 Ruda Śląska | N/A | Poland | 18.85632 | 50.2584 Sopot | N/A | Poland | 18.56003 | 54.4418 Torun | N/A | Poland | 18.59814 | 53.01375 Warsaw | N/A | Poland | 21.01178 | 52.22977 Wroclaw | N/A | Poland | 17.03333 | 51.1 Moscow | N/A | Russia | 37.61556 | 55.75222 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Borås | N/A | Sweden | 12.9401 | 57.72101 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Lund | N/A | Sweden | 13.19321 | 55.70584 Malmo | N/A | Sweden | 13.00073 | 55.60587 Mölndal | N/A | Sweden | 12.01378 | 57.6554 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Birmingham | N/A | United Kingdom | -1.89983 | 52.48142 Eastbourne | N/A | United Kingdom | 0.28453 | 50.76871 Newcastle upon Tyne | N/A | United Kingdom | -1.61396 | 54.97328

0

NCT00623779

[ 5 ]

89

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

This proposed study will test the following hypothesis: Treating depression in Hispanics and African Americans with diabetes will improve their HbA1c and quality of life while on intervention and six months after intervention.

The medication to be used will be sertraline (Zoloft). Sertraline (Zoloft)has been proven in clinical trials to be an effective and well tolerated prescription medication that improves the quality and enjoyment of life for adults suffering from depression . Sertraline is an antidepressant and a member of the family of medications known as selective serotonin reuptake inhibitors (SSRIs). It has excellent tolerability and minimal drug-drug intereactions. The hypothesis will be tested by the following specific aims: 1. To determine if treating mild to moderate depression with sertraline (Zoloft) in patients with diabetes improves HbA1c. 2. To determine if treating mild to moderate depression with sertraline (Zoloft) in patients with diabetes improves quality of life. If our hypothesis proves correct and this treatment of depression is efficient and easy in a county hospital population of African Americans and Hispanics, researchers can move forward in finding fast and efficient means of diagnosing depression in vulnerable populations, including low-literate patients. This study is critical in that it stands to improve the HBA1c (and other metabolic parameters) and quality of life of our underserved minority community, which sadly suffers from a higher rate of almost every disease, including diabetes. Treating mild to moderate depression in a county hospital population of African Americans and Hispanics may improve quality of life and reduce/prevent complications and early death. Secondary outcomes include reduced hospitalizations, fewer missed appointments, and improved adherence to medication.

Diabetes Depression

Diabetes Depression diabetes outcomes quality of life

null

2

arm 1: Placebo 50 mg up to 100 mg daily for 6 months arm 2: Sertraline (Zoloft) 50 mg up to 100 mg daily for 6 months

[ 2, 1 ]

2

[ 0, 0 ]

intervention 1: 50 mg up to 100 mg daily for 6 months intervention 2: 50 mg up to 100 mg daily for 6 months

intervention 1: sertraline intervention 2: Placebo

1

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

0

NCT00624013

[ 4 ]

9

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The study will investigate the effect on growth hormone replacement in patients with isolated growth hormone deficiency on body composition, especially visceral fat mass.

The study was terminated on 15-Dec-2008 due to poor recruitment. Although 9 Patients were enrolled, no patient was randomized nor treated with somatropin. No safety reasons contributed to the termination.

Growth Hormone Deficiency

null

2

arm 1: None arm 2: None

[ 2, 1 ]

2

[ 0, 0 ]

intervention 1: Patients of Placebo Group will be treated with placebo sub-cutaneous in the same way as Somatropin during the double blind treatment phase. To maintain blind subject will be measured in the same way as the treatment group for IGF-I- Levels. Central lab will randomize placebo patients to dose change or maintenance of dose. This will ensure continued blinding of the study to patients and personnel. intervention 2: Fixed doses for patients: MALE: \< 45y 0,4 mg, \> 45y 0,2mg FEMALE: \< 45y 0,5mg, \>45y 0,3mg. for the first 4 weeks half of the dose will be given. After that dose will be increased to the targeted maintenance dose according to IGF-I Levels +/- 2 SD of age adjusted reference range. In case of side effects dosage will remain on half-dose (during the first 4 weeks) or reduced to half dose (after the first 4 weeks). At week 52 patients have the opportunity to switch to open label study restarting with half the given fixed dose which will be adjusted to full dose after 4 weeks.

intervention 1: Placebo intervention 2: Somatropin

2

Bad Aibling | N/A | Germany | 12.01055 | 47.8638 München | N/A | Germany | 13.31243 | 51.60698

0

NCT00630487

[ 5 ]

668

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate the efficacy and safety of Rosuvastatin 5 mg as an hypercholesterolemia treatment comparatively at 2 other statins: Pravastatin 40 mg and Atorvastatin 10 mg. Treatment efficacy will be evaluated by the percentage of LDL-C variation after 8 weeks of treatment.

null

Type IIa and IIb Hypercholesterolaemia

dyslipidemia

null

2

arm 1: Rosuvastatin and Pravastatin arm 2: Rosuvastatin and Atorvastatin

[ 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: 5mg oral intervention 2: 40mg oral intervention 3: 10mg oral

intervention 1: Rosuvastatin intervention 2: Pravastatin intervention 3: Atorvastatin

170

Aix-en-Provence | N/A | France | 5.44973 | 43.5283 Allaire | N/A | France | -2.16514 | 47.63726 Amiens | N/A | France | 2.3 | 49.9 Ancerville | N/A | France | 5.02091 | 48.63574 Angers | N/A | France | -0.55202 | 47.47156 Annecy | N/A | France | 6.12565 | 45.90878 Anzin | N/A | France | 3.50387 | 50.37201 Arles | N/A | France | 4.63031 | 43.67681 Arthez-de-Béarn | N/A | France | -0.61535 | 43.46455 Aspach-le-Bas | N/A | France | 7.15104 | 47.76135 Aubagne | N/A | France | 5.57067 | 43.29276 Auchel | N/A | France | 2.47346 | 50.50345 Bailleul | N/A | France | 2.73594 | 50.73592 Balma | N/A | France | 1.49944 | 43.61111 Beaucaire | N/A | France | 4.64417 | 43.80806 Belfort | N/A | France | 6.85385 | 47.64218 Bersée | N/A | France | 3.14765 | 50.47978 Bézenet | N/A | France | 2.84495 | 46.32902 Béziers | N/A | France | 3.21402 | 43.34122 Biarritz | N/A | France | -1.55684 | 43.48055 Blois | N/A | France | 1.32912 | 47.59432 Bondues | N/A | France | 3.09497 | 50.70196 Bondy | N/A | France | 2.48931 | 48.9018 Bordeaux | N/A | France | -0.5805 | 44.84044 Brignoud | N/A | France | 5.90841 | 45.25821 Bruay-la-Buissière | N/A | France | 2.55 | 50.48333 Bruges | N/A | France | -0.61222 | 44.88287 Bœrsch | N/A | France | 7.43998 | 48.47656 Cabanac-et-Villagrains | N/A | France | -0.55 | 44.6 Cadaujac | N/A | France | -0.53023 | 44.75523 Caen | N/A | France | -0.35912 | 49.18585 Cannes La Bocca | N/A | France | 6.97864 | 43.55166 Carnon-Plage | N/A | France | 3.97877 | 43.54699 Caylus | N/A | France | 1.77105 | 44.23646 Cernay | N/A | France | 7.17699 | 47.8097 Cestas | N/A | France | -0.68194 | 44.74471 Champcueil | N/A | France | 2.44674 | 48.51594 Chanceaux-sur-Choisille | N/A | France | 0.70539 | 47.47145 Chilly-Mazarin | N/A | France | 2.31638 | 48.71489 Clary | N/A | France | 3.39943 | 50.07789 Collioure | N/A | France | 3.08235 | 42.52462 Colombier-Fontaine | N/A | France | 6.6901 | 47.45224 Colomiers | N/A | France | 1.33467 | 43.61058 Coulonieix Chamiers | N/A | France | N/A | N/A Crécy-la-Chapelle | N/A | France | 2.90743 | 48.85918 Crotenay | N/A | France | 5.81298 | 46.75275 Cuise-la-Motte | N/A | France | 3.00588 | 49.38642 Derval | N/A | France | -1.67176 | 47.66772 Dijon | N/A | France | 5.01667 | 47.31667 Eckbolsheim | N/A | France | 7.68768 | 48.58075 Eckwersheim | N/A | France | 7.69687 | 48.68167 Épernay | N/A | France | 3.95922 | 49.04 Épinal | N/A | France | 6.45304 | 48.18324 Étang-sur-Arroux | N/A | France | 4.18988 | 46.8656 Évreux | N/A | France | 1.15082 | 49.02414 Fargues-Saint-Hilaire | N/A | France | -0.44495 | 44.82383 Folembray | N/A | France | 3.29119 | 49.54334 Fos-sur-Mer | N/A | France | 4.94457 | 43.43774 Franconville | N/A | France | 2.23333 | 48.98333 Gamarde-les-Bains | N/A | France | -0.87379 | 43.73323 Gambsheim | N/A | France | 7.88286 | 48.69209 Gradignan | N/A | France | -0.61395 | 44.77362 Grand-Couronne | N/A | France | 1.00647 | 49.35563 Grendelbruch | N/A | France | 7.32239 | 48.49272 Guise | N/A | France | 3.62801 | 49.90055 Harnes | N/A | France | 2.90481 | 50.44643 Horbourg-Wihr | N/A | France | 7.3938 | 48.08106 Is-sur-Tille | N/A | France | 5.10649 | 47.5267 Ivry-sur-Seine | N/A | France | 2.38487 | 48.81568 Jarville-la-Malgrange | N/A | France | 6.20269 | 48.66697 Jeumont | N/A | France | 4.10108 | 50.29658 La Ciotat | N/A | France | 5.60449 | 43.17476 La Courneuve | N/A | France | 2.39627 | 48.92805 La Crèche | N/A | France | -0.3 | 46.36667 La Francheville | N/A | France | 4.71273 | 49.72923 Lacrouzette | N/A | France | 2.3482 | 43.663 Lamagistère | N/A | France | 0.82353 | 44.12498 Laval | N/A | France | -0.77019 | 48.07247 Le Bouscat | N/A | France | -0.59864 | 44.86488 Le Cannet | N/A | France | 7.01912 | 43.57662 Le Passage | N/A | France | 0.60347 | 44.2014 Les Issambres | N/A | France | 6.70202 | 43.34435 Léognan | N/A | France | -0.60052 | 44.72901 Lille | N/A | France | 3.05858 | 50.63297 Lucheux | N/A | France | 2.41309 | 50.19688 Marcq-en-Barœul | N/A | France | 3.08333 | 50.66667 Marseille | N/A | France | 5.38107 | 43.29695 Maslacq | N/A | France | -0.69538 | 43.4401 Mauguio | N/A | France | 4.00739 | 43.61692 Meaux-beauval | N/A | France | N/A | N/A Mennecy | N/A | France | 2.44384 | 48.56903 Mensignac | N/A | France | 0.56054 | 45.22515 Merlimont | N/A | France | 1.61315 | 50.4559 Metz | N/A | France | 6.17269 | 49.11911 Miramont-de-Guyenne | N/A | France | 0.36078 | 44.60182 Mittersheim | N/A | France | 6.94194 | 48.86071 Monfort En Chalosse | N/A | France | N/A | N/A Monguilhem | N/A | France | -0.18166 | 43.85513 Mont-de-Marsan | N/A | France | -0.49713 | 43.89022 Montauroux | N/A | France | 6.76528 | 43.61823 Montbéliard | N/A | France | 6.79823 | 47.50957 Monteux | N/A | France | 4.9963 | 44.03618 Montfrin | N/A | France | 4.59266 | 43.87624 Montigny-lès-Metz | N/A | France | 6.15271 | 49.0956 Montpellier | N/A | France | 3.87635 | 43.61093 Moreuil | N/A | France | 2.48273 | 49.77457 Muespach | N/A | France | 7.37803 | 47.54907 Nancy | N/A | France | 6.18496 | 48.68439 Nogent-sur-Marne | N/A | France | 2.48255 | 48.83669 Noyon | N/A | France | 3.0 | 49.58333 Oberhausbergen | N/A | France | 7.68846 | 48.60607 Orchamps | N/A | France | 5.65873 | 47.14751 Palau-del-Vidre | N/A | France | 2.96106 | 42.57237 Paris | N/A | France | 2.3488 | 48.85341 Pau | N/A | France | -0.35583 | 43.31117 Pauillac | N/A | France | -0.74876 | 45.20023 Périgueux | N/A | France | 0.71439 | 45.18691 Pfulgriesheim | N/A | France | 7.67086 | 48.64403 Phalempin | N/A | France | 3.01584 | 50.51691 Pont-à-Mousson | N/A | France | 6.05635 | 48.90702 Pouilly-en-Auxois | N/A | France | 4.55583 | 47.26238 Poussan | N/A | France | 3.67083 | 43.48944 Pradines | N/A | France | 1.40392 | 44.47893 Puteaux | N/A | France | 2.23894 | 48.88341 Quimperlé | N/A | France | -3.54994 | 47.87215 Rognac | N/A | France | 5.23387 | 43.48761 Rohrwiller | N/A | France | 7.90552 | 48.75709 Roncq | N/A | France | 3.12131 | 50.7533 Roquevaire | N/A | France | 5.60414 | 43.35021 Roubaix | N/A | France | 3.17456 | 50.69421 Saint-Etienne | N/A | France | 4.39 | 45.43389 Saint-Émilion | N/A | France | -0.15609 | 44.89258 Saint-Étienne-de-Montluc | N/A | France | -1.78013 | 47.27622 Saint-Girons | N/A | France | 1.14587 | 42.98491 Saint-Jean-de-Braye | N/A | France | 1.97705 | 47.91303 Saint-Leu-la-Forêt | N/A | France | 2.25 | 49.01667 Saint-Martin-d'Oney | N/A | France | -0.64133 | 43.92757 Saint-Médard-en-Jalles | N/A | France | -0.71779 | 44.8955 Saint-Morillon | N/A | France | -0.50294 | 44.64984 Saint-Rémy | N/A | France | 4.83928 | 46.76334 Saint-Rémy-de-Provence | N/A | France | 4.83167 | 43.78848 Salles | N/A | France | -0.87001 | 44.55174 Sarlat-la-Canéda | N/A | France | 1.21656 | 44.88902 Semur-en-Auxois | N/A | France | 4.33333 | 47.48333 Serres-Castet | N/A | France | -0.35497 | 43.38647 Soissons | N/A | France | 3.32361 | 49.38167 Sorcy-Saint-Martin | N/A | France | 5.63399 | 48.71367 Strasbourg | N/A | France | 7.74553 | 48.58392 Tarare | N/A | France | 4.433 | 45.89614 Targon | N/A | France | -0.2637 | 44.73507 Tartas | N/A | France | -0.80895 | 43.83248 Tassin-la-Demi-Lune | N/A | France | 4.78812 | 45.75499 Thônes | N/A | France | 6.32572 | 45.88123 Thun-Saint-Amand | N/A | France | 3.45115 | 50.47276 Toulon | N/A | France | 5.92836 | 43.12442 Toulouse | N/A | France | 1.44367 | 43.60426 Trie-sur-Baïse | N/A | France | 0.37064 | 43.32114 Varces-Allières-et-Risset | N/A | France | 5.68333 | 45.08333 Vatan | N/A | France | 1.8101 | 47.07447 Vence | N/A | France | 7.11183 | 43.72254 Vélizy-Villacoublay | N/A | France | 2.19395 | 48.78198 Vieux-Boucau-les-Bains | N/A | France | -1.40413 | 43.78644 Villard-Bonnot | N/A | France | 5.88323 | 45.2346 Villette-d'Anthon | N/A | France | 5.12019 | 45.7917 Viry-Châtillon | N/A | France | 2.39318 | 48.67211 Wasselonne | N/A | France | 7.44506 | 48.63779 Wattignies | N/A | France | 3.04394 | 50.58639 Wattrelos | N/A | France | 3.21812 | 50.70118 Yerres | N/A | France | 2.49338 | 48.71785 Yffiniac | N/A | France | -2.67757 | 48.48479

0

NCT00631189

[ 5 ]

162

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to evaluate the effectiveness and safety of tramadol hydrochloride (HCl) 37.5 miligram (mg)/acetaminophen 325 mg compared to gabapentin in participants with diabetic neuropathic (nerve disorder caused by diabetes mellitus) pain.

This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), multi-center and randomized (study drug is assigned by chance) study to compare the effectiveness and safety of tramadol HCl 37.5 mg/acetaminophen 325 mg with gabapentin in participants with diabetic neuropathy. The study will consist of 4 periods: Screening period (up to Day -14), Randomization period (Day 1), Dosage adjustment period (Day 15) and Maintenance period (Day 43). The participants will be randomly assigned to 1 of the 2 treatment groups: tramadol HCl 37.5 mg/acetaminophen 325 mg or gabapentin. Tramadol Hcl/acetaminophen group will receive 1 tablet for 3 days, then 1 tablet twice daily for 4 days followed by 1 tablet thrice daily for next 7 days. If there is no pain relief, the dosage can be increased up to 8 tablets per day for Day 15 to 28, and then the increased dosage will be maintained for Day 29 to 42. Gabapentin group will receive 300 mg on Day 1, 300 mg twice daily on Day 2, and 300 mg thrice daily for Day 3 to 7. Then for Day 8 to 14, participants will receive 300 mg in the morning, 300 mg in the midday and 600 mg in the evening. If there is no pain relief, gabapentin can be increased up to 3600 mg per day for Day 15 to 28, and then the increased dosage will be maintained for Day 29 to 42. Primarily, efficacy will be evaluated by pain intensity using numeric rating scale (NRS). Participants' safety will be monitored throughout the study.

Diabetic Neuropathy

Diabetic neuropathy Ultracet Tramadol hydrochloride Acetaminophen Gabapentin

null

2

arm 1: Participants will receive 1 tablet containing tramadol HCl 37.5 milligram (mg) and acetaminophen 325 mg once daily, at bed time on Days 1 to 3, 1 tablet twice daily on Days 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there is no pain relief, the dosage can be increased up to 8 tablets per day for Days 15 to 28. The increased dose will be maintained for Days 29 to 42. arm 2: Participants will receive Gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg will be administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there is no pain relief, the dosage can be increased up to 3600 mg per day for Days 15 to 28. The increased dose will be maintained for Days 29 to 42.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Participants will receive 1 tablet containing tramadol HCl 37.5 milligram (mg) and acetaminophen 325 mg once daily, at bed time on Days 1 to 3,. 1 tablet twice daily on Days 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there is no pain relief, the dosage can be increased up to 8 tablets per day for Days 15 to 28. The increased dose will be maintained for Days 29 to 42. intervention 2: Participants will receive Gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg will be administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there is no pain relief, the dosage can be increased up to 3600 mg per day for Days 15 to 28. The increased dose will be maintained for Days 29 to 42.

intervention 1: Tramadol hydrochloride/ Acetaminophen intervention 2: Gabapentin

0

null

0

NCT00634543

[ 5 ]

244

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This trial is conducted in the United States of America. The aim of this trial is to explore how different fasting blood glucose targets affect glucose control in patients with type 2 diabetes, when patients are empowered to do dose adjustments themselves.

null

Diabetes Diabetes Mellitus, Type 2

null

2

arm 1: Aggressive FPG (fasting plasma glucose) titration target range group arm 2: Conventional FPG (fasting plasma glucose) titration target range group

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 70-90 mg/dL intervention 2: Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 80-110 mg/dL

intervention 1: insulin detemir intervention 2: insulin detemir

69

0

NCT00634842

[ 2 ]

46

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

A study to evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast (MK-0476) in participants with mild or moderate asthma.

null

Asthma

null

6

arm 1: Participants receive Montelukast inhalation powder, 0.1 mg. * Part I: Administered as a single dose followed by at least a 3-day washout period. arm 2: Participants receive Montelukast inhalation powder, 0.3 mg. * Part I: Administered as a single dose followed by at least a 3-day washout period. arm 3: Participants receive Montelukast inhalation powder, 1 mg. * Part I: Administered as a single dose followed by at least a 3-day washout period. * Part II: Administered once daily (QD) for 5 days followed by at least a 3-day washout period. arm 4: Participants receive Montelukast inhalation powder, 3 mg. * Part I: Administered as a single dose followed by at least a 3-day washout period. * Part II: Administered QD for 5 days followed by at least a 3-day washout period. * Part III: Administered QD for 10 days followed by at least a 7-day washout period. arm 5: Participants receive Montelukast inhalation powder, 10 mg. * Part I: Administered as a single dose followed by at least a 3-day washout period. * Part II: Administered QD for 5 days followed by at least a 3-day washout period. * Part III: Administered QD for 10 days followed by at least a 7-day washout period. arm 6: Participants receive Placebo to Montelukast inhalation powder. * Part I: Administered as a single dose followed by at least a 3-day washout period. * Part II: Administered QD for 5 days followed by at least a 3-day washout period. * Part III: Administered QD for 10 days followed by at least a 7-day washout period.

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

2

[ 0, 0 ]

intervention 1: Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg intervention 2: Placebo dry powder inhaler

intervention 1: Montelukast intervention 2: Placebo

0

null

0

NCT00636207

[ 3 ]

45

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The primary objective of this clinical study is to assess overall safety and tolerability as measured by discontinuation rate due to adverse events in doses up to 120 mg/day in relation to global clinical studies in adult subjects who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV™) criteria for Attention-Deficit/Hyperactivity Disorder (ADHD).

null

Attention Deficit Hyperactivity Disorder

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.

intervention 1: Atomoxetine

11

Beijing | N/A | China | 116.39723 | 39.9075 Changsha | N/A | China | 112.97087 | 28.19874 Guangzhou | N/A | China | 113.25 | 23.11667 Busan | N/A | South Korea | 129.03004 | 35.10168 Incheon | N/A | South Korea | 126.70515 | 37.45646 Jeonju | N/A | South Korea | 127.14889 | 35.82194 Seoul | N/A | South Korea | 126.9784 | 37.566 Neihu Taipei | N/A | Taiwan | N/A | N/A Niao Sung Hsiang | N/A | Taiwan | N/A | N/A Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taoyuan District | N/A | Taiwan | 121.3187 | 24.9896

0

NCT00636818

[ 4 ]

543

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The primary purpose of this study is to compare the safety and efficacy of ABT-335 (investigational drug) coadministered with atorvastatin and ezetimibe to atorvastatin coadministered with ezetimibe in subjects with abnormal lipid (fat) levels in the blood.

null

Dyslipidemias Coronary Heart Disease Combined (Atherogenic) Dyslipidemia Mixed Dyslipidemia

null

2

arm 1: None arm 2: None

[ 1, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 135 mg capsule, daily, 12 weeks intervention 2: placebo capsule, daily, 12 weeks intervention 3: 40 mg, tablet, daily, 12 weeks intervention 4: 10 mg capsule, daily, 12 weeks

intervention 1: ABT-335 intervention 2: placebo intervention 3: atorvastatin intervention 4: ezetimibe

118

0

NCT00639158

[ 3 ]

43

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

This study will examine the effect of red yeast rice extract compared to pravastatin on muscle related complaints in individuals with high cholesterol who have previously been unable to tolerate statin medications due to muscle pain. The study will determine whether red yeast is associated with a lower level of muscle related complaints compared to pravastatin.

20 million Americans are actively treated with statins at an annual cost of 16 billion dollars. Statins are effective therapeutic agents for reducing LDL cholesterol and have documented effectiveness. However, a significant subset of patients (5-18%), cannot tolerate lipid lowering statin therapy due to intolerable muscle-related symptoms characterized by muscle pain and/or weakness. These symptoms affect quality of life and lead to poor adherence. Patients may seek alternative therapies to manage hypercholesterolemia if they have been intolerant of statin therapy. One commonly used alternative treatment option is the Chinese herb red yeast rice extract. Several small studies performed in China, have suggested this treatment is efficacious and well tolerated. In the U.S. red yeast rice is sold over the counter a dietary supplement. The objective of this study is to critically examine the safety and efficacy of the Chinese herb red yeast rice as an alternative lipid lowering therapy, in a statin intolerant population. This objective will be operationalized by a double-blind randomized trial, comparing the effect of red yeast rice extract, to that of pravastatin on the level of myalgia in subjects with a prior history of statin-induced myalgias. The specific aims include: 1. Determine the relative rates of withdrawal from treatment in subjects receiving red yeast rice compared to pravastatin. 2. Determine if red yeast rice is associated with a lower level of muscle pain (myalgia) symptoms compared to pravastatin as measured by the Brief Pain Inventory, a validated pain questionnaire. 3. Determine if red yeast rice is associated with a lower level of muscle weakness compared to pravastatin as measured by a dynamometry, a validated muscle strength testing method.

Hypercholesterolemia Statin-Associated Myopathy

Statin related myalgia Hyperlipidemia Red yeast rice Cardiovascular Diseases Nutritional and Metabolic Diseases

null

2

arm 1: None arm 2: None

[ 1, 0 ]

3

[ 7, 0, 5 ]

intervention 1: Four 600mg capsules twice daily for 12 weeks intervention 2: One 20mg capsule twice daily for 12 weeks intervention 3: Weekly sessions each lasting 3 1/2 hours for 12 weeks

intervention 1: Red Yeast Rice intervention 2: Pravastatin intervention 3: Lifestyle modification program

1

Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238

0

NCT00639223

[ 3 ]

382

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This study will evaluate the safety and tolerability on the oral mucosa of buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12 weeks in opioid dependent individuals who are already on a stable regimen of buprenorphine/naloxone.

Buprenorphine and naloxone soluble film was developed as an alternative dosage form to Suboxone (buprenorphine and naloxone) sublingual tablets and was evaluated for both sublingual and buccal administration. The soluble film dosage is expected to provide the following enhancements and potential advantages over the current Suboxone (buprenorphine and naloxone) product: * mitigation against unintentional pediatric exposure by providing child-resistant packaging in unit dose format. * improvement in subject convenience and compliance by ensuring rapid disintegration. * protection against diversion by providing a dosage form that is very difficult for the subject to remove from the sublingual or buccal mucosa after administration. This provides assurance to the caregiver that the dose has actually been taken appropriately in a supervised setting. * provision of a unit dose product format for hospital and institutional use. * decreased product damage during shipping as compared to Suboxone tablets.

Opioid-Related Disorders

Opioid dependence

null

2

arm 1: Buprenorphine/naloxone film strip administered sublingually arm 2: Buprenorphine/naloxone film strip administered buccally

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by sublingual route intervention 2: Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by buccal route

intervention 1: Buprenorphine/naloxone Film Strip intervention 2: Buprenorphine/naloxone Film Strip

3

0

NCT00640835

[ 3, 4 ]

156

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to evaluate the efficacy and safety of fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that is put on the skin so the drug can enter the body through the skin) and to assess the non-inferiority of fentanyl 1-day application transdermal patch to fentanyl 3-day application (JNS005) transdermal patch in participants with cancer pain.

This is a multi-center (conducted in more than one center) study, consisting of two periods: Period 1 is open-label (all people know the identity of the intervention), non-comparative dose titration phase and Period 2 is double blind (neither physician nor participant knows the treatment that the participant receives), positive control (fentanyl 3-day application transdermal patch is used as control drug) phase. In Period 1, fentanyl 1-day application transdermal patch 12.5 microgram per hour (mcg/hr) will be applied to chest, abdomen, upper arm or thigh and will be maintained for 2 days to ensure the safety of participants. Dose escalation or reduction will be allowed based on participant's condition from Day 3 to Day 11 and thereafter dose will be maintained from Day 11 to Day 13 with a maximum application dose of 100 mcg/hr. The total duration of Period 1 is 14 days (a total of 13 applications; including the day of final patch removal). Participants who met the predefined criteria at the end of dose titration phase will enter the double blind phase. In double blind phase, participants will receive either fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application transdermal patch or fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch at the same dose as used at the completion of Period 1. The duration of Period 2 is 10 days. Efficacy will primarily be evaluated by percentage of participants achieving dose titration success and change in mean visual analog scale (VAS) score. Participants' safety will be monitored throughout the study.

Pain Cancer

Pain Cancer Fentanyl JNS020QD JNS005

null

3

arm 1: Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction is done as per Investigator's discretion (maximum applied dose is 100 mcg/hr) up to Day 11 and then dose is fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase enter the Double Blind Phase. arm 2: Participants who meet the predefined criteria at the end of Titration Phase and enter the Double Blind Phase receive fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days. arm 3: Participants who meet the predefined criteria at the end of Titration Phase and enter the Double Blind Phase receive fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.

[ 0, 0, 1 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction is done as per Investigator's discretion (maximum applied dose is 100 mcg/hr) up to Day 11 and then dose is fixed up to end of treatment period, that is Day 14. intervention 2: Fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days. intervention 3: Fentanyl 3-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days. intervention 4: Placebo matching to fentanyl 3-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase for 10 days. intervention 5: Placebo matching to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase for 10 days.

intervention 1: Fentanyl 1-day transdermal patch (Titration Phase) intervention 2: Fentanyl 1-day transdermal patch (Double Blind Phase) intervention 3: Fentanyl 3-day transdermal patch (Double Blind Phase) intervention 4: Placebo intervention 5: Placebo

43

Asahi | N/A | Japan | 140.65 | 35.71667 Asahikawa | N/A | Japan | 142.36489 | 43.77063 Bunkyō City | N/A | Japan | 139.4217 | 35.5331 Chiba | N/A | Japan | 140.11667 | 35.6 Chikushino-shi | N/A | Japan | 130.5156 | 33.49631 Fukuoka | N/A | Japan | 130.41667 | 33.6 Fushimi | N/A | Japan | 138.89742 | 35.11426 Higashi-Ibaraki | N/A | Japan | N/A | N/A Himeji | N/A | Japan | 134.7 | 34.81667 Hirosaki | N/A | Japan | 140.4725 | 40.59306 Hiroshima | N/A | Japan | 132.45 | 34.4 Hitachi | N/A | Japan | 140.65 | 36.6 Hohfu | N/A | Japan | N/A | N/A Ichinomiya | N/A | Japan | 136.8 | 35.3 Ikeda | N/A | Japan | 135.4298 | 34.82208 Iwakuni | N/A | Japan | 132.22 | 34.16297 Kawachi-Nagano | N/A | Japan | 135.58283 | 34.44108 Kawasaki | N/A | Japan | 139.71722 | 35.52056 Kitakyushu | N/A | Japan | 130.85034 | 33.85181 Kiyose | N/A | Japan | 139.53014 | 35.77952 Kobe | N/A | Japan | 135.183 | 34.6913 Kochi | N/A | Japan | 133.53333 | 33.55 Matsue | N/A | Japan | 133.05 | 35.48333 Matsuyama | N/A | Japan | 132.76574 | 33.83916 Nishinomiya | N/A | Japan | 135.33199 | 34.71562 Okayama | N/A | Japan | 133.93333 | 34.65 Osaka | N/A | Japan | 135.50107 | 34.69379 Ōita | N/A | Japan | 131.6 | 33.23333 Ōtake | N/A | Japan | 132.22063 | 34.20754 Sakai | N/A | Japan | 135.46653 | 34.58216 Sendai | N/A | Japan | 140.86667 | 38.26667 Shigenobu N/A | N/A | Japan | N/A | N/A Sonogishukugō | N/A | Japan | 129.91964 | 33.03689 Sunto | N/A | Japan | N/A | N/A Tamaho N/A | N/A | Japan | N/A | N/A Tokushima | N/A | Japan | 134.56667 | 34.06667 Tokyo | N/A | Japan | 139.69171 | 35.6895 Toyohashi | N/A | Japan | 137.38333 | 34.76667 Tsukuba | N/A | Japan | 140.11667 | 36.08333 Utsunomiya | N/A | Japan | 139.88333 | 36.56667 Wako | N/A | Japan | 139.62333 | 35.78944 Yamaguchi | N/A | Japan | 131.46667 | 34.18333 Yonago | N/A | Japan | 133.33333 | 35.43333

0

NCT00644787

[ 0 ]

65

RANDOMIZED

PARALLEL

7BASIC_SCIENCE

1SINGLE

true

0ALL

false

The purpose of this study is to determine whether sedation affects saccadic eye movements.

null

Saccadic Eye Movements

Sedation Eye Movements

null

4

arm 1: active drug arm 2: sedative arm 3: Sedative arm 4: placebo control

[ 1, 1, 1, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: sedative intervention 2: Sedative intervention 3: sedative intervention 4: saline placebo

intervention 1: propofol intervention 2: dexmedetomidine intervention 3: Midazolam intervention 4: saline placebo

1

Birmingham | Alabama | United States | -86.80249 | 33.52066

0

NCT00646646

[ 5 ]

101

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

true

0ALL

true

The primary purpose of this study is: 1. To compare dexmedetomidine with fentanyl in terms of intra-operative hemodynamics and post-operative analgesia. 2. To determine an analgesic dose response relationship for dexmedetomidine. 3. Compare recovery characteristics of dexmedetomidine to fentanyl.

null

Tonsillitis

Dexmedetomidine, fentanyl, tonsillectomy and adenoidectomy,

null

4

arm 1: Fentanyl 1 micrograms (mcg)/kilogram (kg) arm 2: Fentanyl 2 micrograms (mcg)/kilogram (kg) arm 3: Dexmedetomidine 2 micrograms (mcg)/kilogram (kg) arm 4: Dexmedetomidine 4 micrograms (mcg)/kilogram (kg)

[ 1, 1, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Fentanyl 1mcg/kg, Intravenous (IV) intervention 2: Fentanyl 2mcg/kg, Intravenous (IV) intervention 3: Dexmedetomidine, 2mcg/kg, Intravenous (IV) intervention 4: Dexmedetomidine, 4mcg/kg Intravenous (IV)

intervention 1: Fentanyl intervention 2: Fentanyl intervention 3: Dexmedetomidine intervention 4: Dexmedetomidine

1

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

0

NCT00654511

[ 0 ]

171

RANDOMIZED

SINGLE_GROUP

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to compare the effectiveness of ondansetron, metoclopramide, and promethazine for the treatment of nausea in the adult emergency department population. We hypothesize that a single intravenous dose of ondansetron is more effective in reducing nausea than a single IV dose of metoclopramide, promethazine or normal saline placebo in undifferentiated adult emergency department patients.

null

Nausea

null

4

arm 1: Ondansetron 4 mg intravenous administration arm 2: Metoclopramide 10 mg intravenous administration arm 3: Promethazine 10 mg intravenous administration arm 4: Volume-matched saline placebo

[ 1, 1, 1, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 4 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter intervention 2: 10 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter intervention 3: 12.5 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter intervention 4: Volume matched isotonic sodium chloride solution dose administered over 2 minutes through a peripheral intravenous catheter

intervention 1: Ondansetron intervention 2: Metoclopramide intervention 3: Promethazine intervention 4: Normal Saline

1

Nashville | Tennessee | United States | -86.78444 | 36.16589

0

NCT00655642

[ 5 ]

56

RANDOMIZED

SINGLE_GROUP

0TREATMENT

1SINGLE

false

0ALL

false

This study is to evaluate the efficacy and safety of Tri-Luma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) when used sequentially with a series of intense pulsed light (IPL) treatments in Subjects diagnosed with moderate to severe melasma during a 10 week treatment period.

Same as above.

Melasma

null

2

arm 1: None arm 2: None

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Applied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face. intervention 2: Applied once daily at bedtime on the opposite side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.

intervention 1: Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% intervention 2: Cetaphil® Moisturizing Cream as Inactive Control

2

0

NCT00669071

[ 0 ]

9

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

true

The purpose of the study is to determine whether adding a low dose of testosterone to current antidepressant therapy improves depression and fatigue in women who remain depressed despite necessary adequate doses of anti-depressants. Testosterone will be given over an 8-week period. Testosterone is a hormone that occurs naturally in the body. In women it comes from the ovaries and adrenal glands and is found in amounts that are ten to twenty times lower than in men. In early research studies, testosterone has been shown to have some antidepressant effects in the following groups of subjects: * Women with anorexia nervosa * Women who have low testosterone levels because their pituitary glands do not work * Men with Selective Serotonin Reuptake Inhibitor (SSRI)-resistant depression. However, testosterone administration in women with SSRI or Serotonin-norepinephrine reuptake inhibitor (SNRI) -resistant depression has not been studied.

null

Depression

Depression Major Depressive Disorder

null

1

arm 1: Testosterone patch delivering 300mcg daily for 8-weeks.

[ 1 ]

1

[ 0 ]

intervention 1: Testosterone atch delivering 300mcg daily for 8-weeks

intervention 1: Testosterone

0

null

0

NCT00676676

[ 4 ]

96

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This study was designed to assess the efficacy and safety of CellCept (1 g or 1.5 g orally twice daily for 52 weeks) in patients with pemphigus vulgaris receiving prednisone or other corticosteroids. During the study, patients had their corticosteroid dose gradually reduced if they responded to treatment. The anticipated time on study treatment was 12 months, and the target sample size was \<100 individuals.

null

Pemphigus Vulgaris (PV)

null

3

arm 1: Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks arm 2: Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks arm 3: None

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks intervention 2: Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks intervention 3: Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks

intervention 1: Mycophenolate Mofetil 2 g/Day intervention 2: Mycophenolate Mofetil (MMF) 3 g/Day intervention 3: Placebo

26

Los Angeles | California | United States | -118.24368 | 34.05223 Atlanta | Georgia | United States | -84.38798 | 33.749 Baltimore | Maryland | United States | -76.61219 | 39.29038 St Louis | Missouri | United States | -90.19789 | 38.62727 New York | New York | United States | -74.00597 | 40.71427 Toronto | Ontario | Canada | -79.39864 | 43.70643 Montreal | Quebec | Canada | -73.58781 | 45.50884 Cologne | N/A | Germany | 6.95 | 50.93333 Frankfurt am Main | N/A | Germany | 8.68417 | 50.11552 Heidelberg | N/A | Germany | 8.69079 | 49.40768 Mainz | N/A | Germany | 8.2791 | 49.98419 Münster | N/A | Germany | 7.62571 | 51.96236 Ulm | N/A | Germany | 9.99155 | 48.39841 Haifa | N/A | Israel | 34.99928 | 32.81303 Petah Tikva | N/A | Israel | 34.88747 | 32.08707 Zurich | N/A | Switzerland | 8.55 | 47.36667 Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987 Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987 Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384 Crimea | N/A | Ukraine | N/A | N/A Donetsk | N/A | Ukraine | 37.80224 | 48.023 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Lugnansk | N/A | Ukraine | N/A | N/A Uzhhorod | N/A | Ukraine | 22.2947 | 48.6242 Leicester | N/A | United Kingdom | -1.13169 | 52.6386 London | N/A | United Kingdom | -0.12574 | 51.50853

0

NCT00683930

[ 4 ]

323

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis.

null

Psoriasis

Plaque-type Psoriasis psoriasis

null

2

arm 1: U0267 is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body. arm 2: Vehicle foam is the same as the U0267 foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp). intervention 2: All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).

intervention 1: U0267 Foam intervention 2: Vehicle foam

12

0

NCT00689481

[ 3 ]

103

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of the study is to determine the safety, tolerability, and effectiveness of 2 dose levels of LX6171 given over 28 days in patients with Age Associated Memory Impairment (AAMI).

null

Age-Related Memory Disorders

null

3

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

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: A high dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time. intervention 2: A low dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time. intervention 3: Matching placebo dosing with daily oral intake for 28 days in the morning at approximately the same time.

intervention 1: LX6171 High Dose intervention 2: LX6171 Low Dose intervention 3: Placebo

2

Utrecht | N/A | Netherlands | 5.12222 | 52.09083 Zuidlaren | N/A | Netherlands | 6.68194 | 53.09417

0

NCT00691808

[ 2 ]

24

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

0ALL

false

This study will evaluate the effects of mild and moderate impairment of hepatic function on the single-dose pharmacokinetics, safety and tolerability of AG-013736.

null

Hepatic Insufficiency

hepatic impairment

null

3

arm 1: Subjects with mild hepatic impairment (Child Pugh class A, score 5-6) arm 2: Subjects with moderate hepatic impairment(Child Pugh class B,score 7-9) arm 3: Group 1 1\) subjects with normal hepatic function

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet. intervention 2: Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet. intervention 3: Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.

intervention 1: AG-013736 intervention 2: AG-013736 intervention 3: AG-013736

2

0

NCT00692341

[ 5 ]

28

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this research study is to evaluate the efficacy of SARNA Sensitive Lotion in the treatment of uremic pruritus in adult hemodialysis patients in a double-blind Controlled comparative trial.

This was a 4-week, randomized, double-blind, controlled study. Fourteen subjects received treatment lotion (1% pramoxine HCl) and the remaining 14 received a bland emollient (Cetaphil lotion). A target lesion limited to one anatomic site, excluding face and genitals, was selected at baseline. Each subject was instructed to apply lotion twice daily to all affected areas of pruritus for four weeks. The use of any other topical or systemic medication to treat uremic pruritus was not permitted while participating in the study. Subjects were clinically evaluated for erythema, xerosis, lichenification and overall severity at baseline, week 1, and week 4 (end of study)

Pruritis

Uremic Pruritis

null

2

arm 1: 1% pramoxine Sarna lotion arm 2: Placebo Cetaphil lotion

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Active Ingredient: Pramoxine Hydrochloride Inactive ingredients:Benzyl Alcohol, Carbomer 940, Cetyl Alcohol, Dimethicone, Glyceryl Stearate (\&) PEG-100 Stearate, Isopropyl Myristate, Petrolatum, PEG 8 Stearate, Purified Water, Stearic Acid, Sodium Hydroxide intervention 2: Purified Water, Glycerin, Hydrogenated Polyisobutene, Cetearyl Alcohol, Ceteareth 20, Macadamia Nut Oil, Dimethicone, Tocopheryl Acetate, Stearoxytrimethylsilane, Stearyl Alcohol, Panthenol, Farnesol, Benzyl Alcohol, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Citric Acid

intervention 1: Sarna intervention 2: Cetaphil

1

Winston-Salem | North Carolina | United States | -80.24422 | 36.09986

0

NCT00693654

[ 4 ]

1,275

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to determine the safety and efficacy of azilsartan medoxomil, once daily (QD), compared to placebo and olmesartan in participants with essential hypertension.

Hypertension affects approximately 50 million individuals in the United States. As the population ages, the prevalence of hypertension will continue to increase if broad and effective preventive measures are not implemented. According to the World Health Organization, hypertension is the most common attributable cause of preventable death in developed nations, as uncontrolled hypertension greatly increases the risk of cardiovascular disease, cerebrovascular disease, and renal failure. Despite the availability of antihypertensive treatments, hypertension remains inadequately controlled; only about one-third of patients continue to maintain control successfully. TAK-491 (azilsartan medoxomil) is an angiotensin II receptor blocker and this study is being conducted to evaluate the efficacy and safety of oral azilsartan medoxomil compared to placebo and olmesartan in subjects with essential hypertension. Individuals who want to participate in this study will be required to provide written informed consent. Study participation is anticipated to be about 11 weeks. Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, vital signs including sitting blood pressure and pulse, body height and weight, physical examinations and electrocardiograms. Outside of the study center, participants will be required to wear an ambulatory blood pressure monitoring device at 24 hour intervals.

Hypertension

Essential Hypertension Cardiovascular Disease High Blood Pressure Drug Therapy

null

5

arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

[ 0, 0, 0, 1, 2 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Azilsartan medoxomil 20 mg, tablets, azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets and olmesartan 40 mg placebo-matching tablets, orally, for up to 6 weeks. intervention 2: Azilsartan medoxomil 40 mg, tablets, azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets and olmesartan 40 mg placebo-matching tablets, orally, for up to 6 weeks. intervention 3: Azilsartan medoxomil 80 mg, tablets, azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 40 mg placebo-matching tablets and olmesartan 40 mg placebo-matching tablets, orally, once daily for up to 6 weeks. intervention 4: Olmesartan 40 mg, tablets, azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 40 mg placebo-matching tablets and azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily for up to 6 weeks. intervention 5: Azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and olmesartan 40 mg placebo- matching tablets, orally, once daily for up to 6 weeks.

intervention 1: Azilsartan medoxomil and olmesartan intervention 2: Azilsartan medoxomil and olmesartan intervention 3: Azilsartan medoxomil and olmesartan intervention 4: Olmesartan intervention 5: Placebo

85

0

NCT00696241

[ 5 ]

20

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this research study is to measure adherence to the study drug (Carac) for the treatment of actinic keratoses.

The purpose of this research study is to measure adherence to the study drug for the treatment of actinic keratoses. The study drug is 5-Fluorouracil (Carac®); it will be used in this study to treat actinic keratoses on the face and anterior scalp. This proposed study will evaluate adherence to topical Carac® in 20 adults age 50 or greater with actinic keratoses from a clinic population. Adherence data will be collected by the MEMS cap (Medication Event Monitoring System

Actinic Keratosis

null

1

arm 1: each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions

[ 0 ]

1

[ 0 ]

intervention 1: Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions

intervention 1: Fluorouracil 0.5%

1

Winston-Salem | North Carolina | United States | -80.24422 | 36.09986

0

NCT00696488

[ 4 ]

91

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

true

0ALL

null

This study will explore potential next-day residual effects of a single evening dose of 3mg of the hypnotic, eszopiclone, 7.5mg of zopiclone, and placebo, in healthy adult subjects.

null

Healthy Subjects Sleep Initiation and Maintenance Disorders

Zopiclone Hypnotic Residual effects Eszopiclone

null

1

arm 1: All subjects received all three treatments in a randomised order

[ 0 ]

1

[ 0 ]

intervention 1: Subjects receive either 3mg GSK1755165, matching placebo or 7.5mg zopiclone

intervention 1: GSK1755165; placebo; zopiclone

1

Guildford | Surrey | United Kingdom | -0.57427 | 51.23536

0

NCT00699608

[ 3 ]

265

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

This Phase IIb study is designed to assess the safety and efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel when applied to an area of skin, containing 4-8 AK lesions on the face or scalp.

null

Actinic Keratosis

Peplin Actinic keratosis PEP005

null

8

arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None

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

8

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

intervention 1: 0.005%, two days treatment intervention 2: 0.01%, two days treatment intervention 3: 0.015%, two days treatment intervention 4: two days treatment intervention 5: 0.005%, three days treatment intervention 6: 0.01%, three days treatment intervention 7: 0.015%, three days treatment intervention 8: three days treatment

intervention 1: PEP005 Topical Gel intervention 2: PEP005 Topical Gel intervention 3: PEP005 Topical Gel intervention 4: Vehicle gel intervention 5: PEP005 Topical Gel intervention 6: PEP005 Topical Gel intervention 7: PEP005 Topical Gel intervention 8: Vehicle gel

28

0

NCT00700063

[ 4 ]

256

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

true

0ALL

false

The purpose of this study is to evaluate the efficacy and safety of multiple doses of Ibuprofen 600 mg Extended-Release Tablets in a study of dental pain following extraction of third molar teeth.

This is a single-center, multiple-dose, randomized, placebo-controlled, double-blinded, parallel group trial to evaluate the efficacy and safety of multiple doses of Ibuprofen 600 mg Extended-Release Tablets in a study of dental pain following extraction of third molar teeth. The surgery will consist of surgical extraction of 1-2 impacted third molars, of which one must be a mandibular impaction that is partially impacted in either tissue or bone. Subjects will be stratified according to baseline pain intensity, as rated on an 11-point pain intensity numerical rating scale (PI-NRS)and gender.

Pain Post-Operative Pain Third Molar Extraction

null

2

arm 1: One-hundred and sixty subjects will be randomly assigned to the Ibuprofen 600 mg ER treatment group based on gender and baseline pain intensity, as rated on an 11-point numerical rating scale (PI-NRS; 5-7 moderate pain, or 8-10, severe pain). arm 2: Eighty subjects will be randomly assigned to the Placebo treatment group based on gender and baseline pain intensity, as rated on an 11-point numerical rating scale (PI-NRS; 5-7 moderate pain, or 8-10, severe pain).

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Ibuprofen 600 mg Extended-Release Tablet: One 600 mg tablet taken orally every 12 hours or twice daily (BID). Each dose was administered with at least 6 ounces of water. Dose 1 was administered at hour 0, Dose 2 was administered at hour 12, Dose 3 was administered at hour 24 and Dose 4 was administered at hour 36. intervention 2: Placebo: One matching placebo tablet was taken orally every 12 hours or twice daily (BID). Each dose was administered with at least 6 ounces of water. Dose 1 was administered at hour 0, Dose 2 was administered at hour 12, Dose 3 was administered at hour 24 and Dose 4 was administered at hour 36.

intervention 1: Ibuprofen 600 mg Extended-Release Tablets intervention 2: Placebo

1

Salt Lake City | Utah | United States | -111.89105 | 40.76078

0

NCT00707057

[ 4 ]

65

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

true

0ALL

false

The purpose of this study is to investigate the efficacy of different sodium fluoride (NaF) containing toothpastes in prevention of dental caries. Change from baseline fluoride data at various time points up to four hours after a single brushing with NaF containing toothpastes will be evaluated.

Topical fluorides in a wide variety of delivery systems have been proven to be clinically effective in the prevention of dental caries. It is generally agreed that fluoride has its anti-caries effect mainly by decreasing the rate of enamel demineralization and enhancing the rate of enamel remineralization. There is a general consensus that level of fluoride in plaque fluid, may be directly related to the anti caries effects of fluoride. Also, fluoride levels in the oral fluids decrease rapidly after topical fluoride application, mainly due to the diluting and washing effect of saliva followed by periodic swallowing. To evaluate fluoride content, plaque samples will be collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride will be calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis.

Dental Caries

toothpaste plaque fluid fluoride

null

4

arm 1: Participants brushed for one timed minute with 1.6g of NaF/silica and 0.4 percent carbopol toothpaste containing 1450ppmF as NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. arm 2: Participants brushed for one timed minute with 1.6g of NaF toothpaste containing 1400ppmF as NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. arm 3: Participants brushed for one timed minute with 1.6g of NaMFP/NaF toothpaste containing 1450ppmF from NaMFP and NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. arm 4: Participants brushed for one timed minute with 1.6g of fluoride free toothpaste. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.

[ 0, 1, 1, 2 ]

2

[ 0, 0 ]

intervention 1: Different fluoride toothpastes containing between 1400ppmF - 1450ppmF of fluoride as NaF intervention 2: Fluoride free toothpaste (0ppmF)

intervention 1: Sodium Fluoride (NaF) intervention 2: Placebo

1

Indianapolis | Indiana | United States | -86.15804 | 39.76838

0

NCT00708305

[ 3 ]

150

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to assess the efficacy, safety and tolerability of RX-3341 (delafloxacin), a fluoroquinolone, versus tigecycline, a glycylcycline antibacterial drug, in the treatment of complicated skin and skin structure infections.

null

Skin Structure Infections Bacterial Skin Diseases Staphylococcal Skin Infections

complicated skin

null

3

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

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: 300 mg intravenous every 12 hours intervention 2: 450 mg intravenous every 12 hours intervention 3: 100 mg then 50 mg intravenous tigecycline every 12 hours

intervention 1: delafloxacin intervention 2: delafloxacin intervention 3: tigecycline

14

0

NCT00719810

[ 4 ]

314

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in bipolar 1 disorder patients.

This is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2 dose levels of Staccato Loxapine, 5 and 10 mg. Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. The primary endpoint is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, performed at 2 hours after the first dose.

Bipolar I Disorder

Bipolar 1 disorder, agitation, acute, treatment

null

3

arm 1: Inhaled Staccato Placebo, may repeat after 2 hours x 2 arm 2: Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2 arm 3: Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2

[ 2, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Inhaled loxapine Placebo, may repeat after 2 hours x 2 intervention 2: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2 intervention 3: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2

intervention 1: Inhaled Placebo intervention 2: Inhaled loxapine 5 mg intervention 3: Inhaled loxapine 10 mg

6

0

NCT00721955

[ 4 ]

333

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.

null

Allergic Rhinitis

null

2

arm 1: Mometasone furoate nasal spray 200 mcg QD (once per day) arm 2: Matching placebo nasal spray

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days intervention 2: Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days

intervention 1: Mometasone furoate nasal spray (MFNS) intervention 2: Matching placebo nasal spray

0

null

0

NCT00728416

[ 2 ]

12

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

true

0ALL

true

The purpose of this study was to evaluate the pharmacokinetic parameters and safety of a single dose of ST-246 400mg Form I versus ST-246 400mg Form V capsules in fed normal healthy volunteers.

This was a Phase I, double-blind, cross-over, single-dose study of the orally administered anti-orthopoxvirus compound, ST-246, to 12 healthy, fed volunteers between the ages of 18 and 50 years. Subjects were randomized such that 6 subjects received either ST-246 Form I (monohydrate) followed 10 days later after a wash-out period by Form V (hemihydrate), and 6 subjects received ST-246 Form V followed by Form I, as for the previous group. Both forms of ST-246 were similar in the way they were manufactured. The only difference between Form I and Form V may be related to how it dissolves, and this may affect the way that it is absorbed in the human body. Information about any side-effects that may occur will also be collected in this study.

Orthopoxviral Disease Smallpox Monkey Pox

Orthopoxviral Smallpox Monkey pox

null

2

arm 1: Each of six subjects receive a single oral 400 mg dose (2×200 mg) of ST-246 Form I (monohydrate) in the first intervention period, followed 10 days later (3 days post-treatment monitoring and 7 days wash-out period) in the second intervention period by a single oral 400 mg dose (2×200 mg) of ST-246 Form V (hemihydrate). Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat. arm 2: Each of six subjects receive a single oral 400 mg dose (2×200 mg) of ST-246 Form V (hemihydrate) in the first intervention period, followed 10 days later (3 days post-treatment monitoring and 7 days wash-out period) in the second intervention period by a single oral 400 mg dose (2×200 mg) of ST-246 Form I (monohydrate). Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: First Intervention is on Days 1 - 3, and includes 6 patients dosed once orally with ST-246 Form I (Arm 1), and 6 patients dosed once orally with ST-246 Form V (Arm 2). intervention 2: Second Intervention is on Days 11 - 13 (after a 3 day post-treatment monitoring and 7 day wash-out period) where the 6 patients previously given ST-246 Form I (Arm 1) are now dosed once orally with ST-246 Form V, and the 6 patients previously given ST-246 Form V (Arm 2) are now dosed once orally with ST-246 Form I.

intervention 1: ST-246 Days 1 - 3 intervention 2: ST-246 Days 11 - 13

1

Orlando | Florida | United States | -81.37924 | 28.53834

0

NCT00728689

[ 4 ]

324

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.

null

Allergic Rhinitis

null

2

arm 1: Mometasone furoate nasal spray 200 mcg QD (once per day) arm 2: Matching placebo nasal spray

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days intervention 2: Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days

intervention 1: Mometasone furoate nasal spray (MFNS) intervention 2: Matching placebo nasal spray

0

null

0

NCT00733005

[ 5 ]

80

RANDOMIZED

PARALLEL

1PREVENTION

3TRIPLE

false

0ALL

false

The purpose of this study is to determine whether OM-85 BV (Broncho-Vaxom)has any effect on respiratory infections, infection related wheezing attacks, beta-2 agonist use, duration of attacks and effect on serum cytokine levels.

Context: Respiratory infections are the major cause of wheezing attacks in children with recurrent wheezing or asthma in preschool age. OM-85 BV is an bacteria lysate which has been proven to prevent respiratory infections about 40 percent in children. Objective: To determine if using OM-85 BV diminish the number and duration of the respiratory infections and respiratory infection related wheezing attacks,beta-2 agonist and steroid use, and number and duration of hospitalizations in children with recurrent wheezing and asthma. And also to determine if OM-85 BV has any effect on serum cytokine levels after 6 months. Study Design/Setting/Participants: A double-blind, randomized, controlled trial of OM-85 BV versus placebo for children 6 months to 6 years of age who have respiratory tract infection related recurrent wheezing attacks. Intervention: Participants will receive either active Broncho-Vaxom or placebo for 3 months. Study Measures: They follow up for 1 year for number and duration of wheezing attacks, number, type and duration of respiratory infections, number and duration of beta-2 agonist use, number and duration of steroid use and number and duration of hospitalizations. Serum cytokine levels will measure to determine if Broncho-Vaxom has any effect on serum cytokine levels (at the beginning of the trial and sixth months of the trial).

Asthma

wheezing asthma childhood OM-85 BV Broncho-Vaxom

null

2

arm 1: The children received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months. arm 2: The children received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 3.5 mg capsule, 1 capsule per day for first 10 day of the month, for 3 months intervention 2: 3.5 mg oral placebo capsule, 1 placebo capsule per day for first 10 days of the months for 3 months

intervention 1: OM-85 BV (Broncho-Vaxom) intervention 2: OM-85 BV (placebo)

2

0

NCT00733226

[ 5 ]

314

RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to assess how patients with gastro-oesophageal reflux disease (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still experiencing symptoms will benefit from a change in treatment.

null

Gastroesophageal Reflux Disease

heartburn reflux proton pump inhibitor

null

1

arm 1: None

[ 0 ]

4

[ 0, 3, 10, 3 ]

intervention 1: Once a day intervention 2: every visit intervention 3: every visit intervention 4: as needed

intervention 1: Esomeprazole 40 mg intervention 2: Physical Exam intervention 3: Quality of Life Questionnaires intervention 4: pregnancy test, if applicable

10

Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Santiago | N/A | Chile | -70.64827 | -33.45694 Temuco | N/A | Chile | -72.59738 | -38.73628 Viña del Mar | N/A | Chile | -71.55183 | -33.02457 Barranquilla | N/A | Colombia | -74.78132 | 10.96854 Bogotá | N/A | Colombia | -74.08175 | 4.60971 Medellín | N/A | Colombia | -75.57151 | 6.245 Barquisimeto | N/A | Venezuela | -69.35703 | 10.0647 Caracas | N/A | Venezuela | -66.87919 | 10.48801 San Cristóbal | N/A | Venezuela | -72.23576 | 7.76593

0

NCT00734097

[ 2 ]

18

NA

SINGLE_GROUP

0TREATMENT

0NONE

true

1FEMALE

false

This study will assess possible drug-drug interactions with specific isoenzymes over a total study duration of 6-8 weeks. Blood samples collected pre and post-dose, and urine samples collected post dose will be analyzed.

This is an open-label, multiple-dose, non-randomized study to assess the drug-drug interactions of Proellex® with cytochrome P450 isoenzymes in healthy female subjects. On Day 1, following an overnight fast and morning void of the bladder, subjects will be administered CYP probe drugs orally. Serial blood samples will be collected at pre-dose and post-dose. Subjects will be administered two Proellex® 25 mg capsules (50 mg total dose) at approximately 0800 hours on Day 2 and 0700 hours on Days 3 through 8. One hour after administration of Proellex® on Day 8, the five CYP probe drugs will be administered and blood and urine samples collected as on Day 1. Blood samples for the determination of plasma concentrations of CDB-4124 and its metabolite CDB-4453 will be collected at pre-dose (trough) on Days 6, 7, and 8 to determine if steady-state conditions have been achieved. Samples will also be collected on Day 8 at 1, 2, 8 and 24 hour after administration of Proellex® to determine the plasma concentrations of CDB-4124 and CDB-4453.

Drug Interactions

Drug-drug interactions DDI

null

1

arm 1: Proellex 50 mg CYP1A2 probe CYP2C9 probe CYP2C19 probe CYP2D6 probe CYP3A4 probe

[ 0 ]

6

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

intervention 1: 2, 25 mg Proellex capsules administered daily intervention 2: Caffeine (200 mg) intervention 3: Tolbutamide (250 mg) intervention 4: Omeprazole (20 mg) intervention 5: Dextromethorphan (30 mg) intervention 6: Midazolam (2mg)

intervention 1: Proellex intervention 2: CYP1A2 probe intervention 3: CYP2C9 probe intervention 4: CYP2C19 probe intervention 5: CYP2D6 probe intervention 6: CYP3A4 probe

1

Hackensack | New Jersey | United States | -74.04347 | 40.88593

0

NCT00741468

[ 5 ]

355

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

1FEMALE

null

The purpose of this study in healthy sexually active females is to evaluate the cycle control with norgestimate/ethinyl estradiol versus drospirenone/ethinyl estradiol.

This is a randomized, open-label, active-controlled, multicenter study in healthy sexually active females to evaluate cycle control with norgestimate/ethinyl estradiol versus drospireneone/ethinyl estradiol. The Open-Label Treatment Phase will last for three 28-day cycles. Approximately 300 patients will be randomized in a 1:1 fashion according to a predetermined randomization schedule. Patients will be seen for a baseline visit (Visit 1) up to 35 days prior to dosing to obtain informed consent, have a physical examination including a breast exam, height and weight, vital signs, a Chlamydia test and a urine pregnancy test performed, and to give their medical history. Patients will be instructed to report bleeding data using an interactive voice response system (IVRS) based diary on a daily basis. Patients will be instructed to continue taking 1 pill each day for 3 cycles, record this information daily in the IVRS and to contact the study site if they have any questions or adverse events they would like to discuss. The final study visit (Visit 2) will occur on Day 8 after completing 3 cycles of study medication. Patients will be weighed, have vital signs performed, report any adverse events and or changes in concomitant medications, and complete the satisfaction questionnaire at the final visit. Safety will be assessed by physical examinations, adverse events, body weight and vital signs. Patients randomized to drospireneone/ethinyl estradiol and taking any medication that could increase serum potassium levels (as outlined in the Package Insert) will also have their potassium level checked during their first cycle of treatment (Days 15 to 28 of treatment). Three 28-day cycles of either norgestimate/ethinyl estradiol or drospirenone/ethinyl estradiol.

Contraception

contraception bleeding cycle control

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: Norgestimate/ethinyl estradiol; Drospirenone/ethinyl estradiol

0

null

0

NCT00745901

[ 2 ]

16

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-0941 in Japanese patients with Type 2 Diabetes.

null

Diabetes Mellitus, Non-Insulin-Dependent

null

6

arm 1: Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. arm 2: Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two treatment periods. arm 3: Participants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. arm 4: Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. arm 5: Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two treatment periods. arm 6: Participants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods.

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

2

[ 0, 0 ]

intervention 1: Placebo tablets before every meal (q.a.c) Treatment period is 5 days. intervention 2: MK-0941 5 mg tablets q.a.c.; 10 mg tablets q.a.c.; 20 mg tablets q.a.c.; or 40 mg tablets q.a.c. Treatment period is 5 days.

intervention 1: Placebo intervention 2: MK-0941

0

null

0

NCT00754130

[ 3 ]

229

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

Safety Follow-Up Trial to PDC-INS-0008 and MKC-TI-005

This is an uncontrolled study without comparator. Subjects were followed up to 4 years on Technosphere Insulin. Of 229 subjects 199 were exposed for ≥12 mo, 175 for ≥ 24 mo, 60 for ≥ 36 mo, 31 for ≥ 42 mo, \& 2 for 48 mo.

Type 2 Diabetes Mellitus

null

1

arm 1: Technosphere® Insulin Inhalation Powder

[ 0 ]

1

[ 0 ]

intervention 1: Inhalation starting at 15, 30, or 60U doses and can be titrated up or down by 15U to a minimum of 15U or a maximum of 90U

intervention 1: Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler

40

0

NCT00754624

[ 3 ]

74

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed 6-week acute treatment in study NCT00839423 / 11492A.

null

Major Depressive Disorder

Major Depressive Disorder Long-term Safety Open-label

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: 5 or 10 mg/day; tablets; orally

intervention 1: Vortioxetine (Lu AA21004)

0

null

0

NCT00761306

[ 3 ]

135

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This is a 6-week clinical study (4 weeks of treatment, once per day, plus a 2-week follow-up period) of a topical foam to treat athlete's foot. The active ingredient in the foam -- econazole nitrate 1% -- is the same active pharmaceutical ingredient in a cream that your doctor can currently prescribe to treat athlete's foot. This study will help to understand if the foam works the same as the cream to treat athlete's foot.

Treating athlete's foot with a cream can leave a greasy, wet feeling on the foot that is uncomfortable to the user and messy on clothing and foot wear. A foam formulation that spreads easily and rubs-in easily that is as effective as the (reference) cream formulation in treating athlete's foot would be a benefit to the user. This study is designed to substantiate a clinical bridge between econazole nitrate foam 1% and econazole nitrate cream 1% based on clinical outcome, safety, and pharmacokinetic data. The study is (foam) vehicle-controlled and is randomized 1 to 1 to 1 (foam:cream:vehicle).

Tinea Pedis Athlete's Foot

Econazole Foam Quinnova

null

3

arm 1: Econazole Nitrate Cream 1% arm 2: Econazole Nitrate Foam 1% arm 3: Vehicle Foam

[ 1, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Topical cream, applied once daily for 4 weeks. intervention 2: Topical foam, applied once daily for 4 weeks. intervention 3: Topical foam, applied once daily for 4 weeks.

intervention 1: Econazole Nitrate Cream 1% intervention 2: Econazole Nitrate Foam 1% intervention 3: Vehicle Foam

6

0

NCT00768599

[ 5 ]

60

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to evaluate the efficacy, safety and to assess the impact of the treatment on quality of life of long-acting methylphenidate in adult participants with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a clinical condition beginning in childhood and is characterized by inadequate levels of attention, hyperactivity and impulsiveness.

This is an open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study), single arm study of multiple doses of long-acting methylphenidate in participants with ADHD. The study will consist of 2 phases; a screening phase and a treatment phase. The duration of participation in the study for an individual participant will be up to 12 weeks. Participants will be given 18 milligram (mg) of long-acting methylphenidate daily in the morning and titrated up (slow increase in drug dosage guided by participant's responses) to 36 mg per day (mg/day) on Day 8. Depending on response, tolerability and clinician's judgment, the dose could be escalated to the next dose level of 54 mg/day on Day 28 to a maximum of 72 mg/day on Day 56, until each participant achieved optimal dose. Participant's safety will be monitored throughout the study.

Attention Deficit Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder Methylphenidate Concerta CONQoL

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Long-Acting Methylphenidate within the range of 18, 36, 54 and 76 milligram will be orally administered once daily up to Day 56.

intervention 1: Long-Acting Methylphenidate

5

Belo Horizonte | N/A | Brazil | -43.93778 | -19.92083 Porto Alegre | N/A | Brazil | -51.23019 | -30.03283 Rio de Janeiro | N/A | Brazil | -43.18223 | -22.90642 Salvador | N/A | Brazil | -38.49096 | -12.97563 São Paulo | N/A | Brazil | -46.63611 | -23.5475

0

NCT00783835

[ 2 ]

23

NON_RANDOMIZED

SINGLE_GROUP

7BASIC_SCIENCE

0NONE

true

0ALL

false

Rosiglitazone is predominantly metabolized by cytochrome P450 (CYP) 2C8. Quinine sulfate is an inhibitor of CYP 2C8. This study will evaluate the effect of multiple doses of quinine sulfate at steady-state on the pharmacokinetics of single-dose rosiglitazone in healthy adult subjects.

Rosiglitazone is predominantly metabolized by cytochrome P450 (CYP) 2C8. Quinine sulfate is an inhibitor of CYP 2C8. This study will evaluate the effect of multiple doses of quinine sulfate at steady-state on the pharmacokinetics of single-dose rosiglitazone in healthy adult subjects. On study Day 1 after a fast of at least 10 hours, twenty four healthy, non-smoking, non-obese, non-pregnant adult volunteers between the ages of 18 and 45 will be given one oral dose of rosiglitazone (1 x 4 mg tablet). Fasting will continue for 4 hours after the dose. Blood samples will be drawn from all participants before dosing and for 24 hours post-dose at times sufficient to adequately define the pharmacokinetics of rosiglitazone. A 2 day washout period will be completed after the first dose of rosiglitazone on Day 1. On Days 4-7 all subjects will receive a dose of quinine sulfate (2 x 324 mg capsules) every 8 hours starting with the 7:15 a.m. dose on Day 4 and continuing through the 11:15 p.m. dose on Day 7. Doses of quinine sulfate on Days 4-6 will be administered without regard to meals. On the morning of Day 7 after an overnight fast of at least 10 hours, all study participants will receive co-administered doses of rosiglitazone (1 x 4 mg tablet) and quinine sulfate (2 x 324 mg capsules). Fasting will continue for 4 hours after the dose. Blood samples will be drawn from all participants before dosing and for 24 hours post-dose at times sufficient to adequately determine the pharmacokinetics of rosiglitazone. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout participation in the study for adverse reactions to the study drug and/or procedures. Blood pressure (sitting for at least 3 minutes) and pulse will be measured prior to dosing and at 1, 2 and 3 hours after the morning dose of rosiglitazone on Days 1 and 7. Electrocardiograms (EKG) will be recorded on Day 4 before dosing of quinine sulfate and at 1, 2 and 4 hours post-dose and on Day 7 before the co-administered doses of rosiglitazone and quinine sulfate and at 1, 2 and 4 hours post-dose. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.

Healthy

rosiglitazone quinine sulfate drug interactions cytochrome p450

null

2

arm 1: Baseline rosiglitazone pharmacokinetics. arm 2: Rosiglitazone pharmacokinetics in the presence of steady state quinine sulfate.

[ 1, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Rosiglitazone 4 mg tablet administered as a single oral dose on the morning of Day 1. intervention 2: Co-administered single oral doses of rosiglitazone 4 mg (1 x 4 mg tablet) and quinine sulfate 648 mg (2 x 324 mg capsules) on the morning of Day 7. intervention 3: Co-administered single oral doses of rosiglitazone 4 mg (1 x 4 mg tablet) and quinine sulfate 648 mg (2 x 324 mg capsules) on the morning of Day 7.

intervention 1: Rosiglitazone 4 mg Tablets intervention 2: Rosiglitazone 4 mg Tablets intervention 3: Quinine Sulfate 324 mg Capsules

1

East Grand Forks | Minnesota | United States | -97.02452 | 47.92998

0

NCT00785213

[ 2 ]

24

NON_RANDOMIZED

SINGLE_GROUP

7BASIC_SCIENCE

0NONE

true

0ALL

false

Ciprofloxacin is moderate inhibitor of cytochrome P450 1A2 (CYP1A2), one of the enzymes responsible for the metabolism of quinine. This study will evaluate the effect of ciprofloxacin-related inhibition of CYP1A2 on the pharmacokinetics of quinine sulfate.

Ciprofloxacin is moderate inhibitor of cytochrome P450 1A2 (CYP1A2), one of the enzymes responsible for the metabolism of quinine. This study will evaluate the effect of ciprofloxacin-related inhibition of CYP1A2 on the pharmacokinetics of quinine sulfate. In the morning on study Day 1 after a fast of at least 10 hours, twenty-four healthy, non-smoking, non-obese, non-pregnant adult volunteers between the ages of 18 and 45 will be given one oral dose of quinine sulfate (2 x 324 mg capsules). Fasting will continue for 4 hours after the dose. Blood samples will be drawn from all participants before dosing and for 36 hours post-dose at times sufficient to adequately define the pharmacokinetics of quinine sulfate. A 7-day washout period will be completed after the first dose of quinine sulfate on Day 1. Beginning at 07:45 am on Day 8 and continuing through Day 10, all subjects will return to the clinic for non-confined dosing of ciprofloxacin (1 x 500 mg tablet) every 12 hours. Administered ciprofloxacin doses on these days will not be in a fasted state. At 07:45 am on Day 11 after a fast of at least 10 hours, all study participants will receive a co-administered single oral dose of quinine sulfate (2 x 324 mg capsules) and ciprofloxacin (1 x 500 mg tablet). A final dose of ciprofloxacin (1 x 500 mg tablet) will be administered 12 hours later. Blood samples will be drawn from all participants before dosing and for 36 hours post-dose at times sufficient to adequately define the pharmacokinetics of quinine sulfate. Fasting will continue for 4 hours following the co-administered dose of quinine sulfate and ciprofloxacin. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout participation in the study for adverse reactions to the study drug and/or procedures. Seated blood pressure and pulse will be measured pre-dose and at 1, 2 and 3 hours post-dose on Days 1 and 11. An electrocardiogram (ECG) will be done pre-dose and at 1, 2 and 4 hours post-dose on Days 1 and 11. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the Investigator and reported in the subject's case report form.

Healthy

quinine sulfate ciprofloxacin drug interactions cytochrome p450 male female adult pharmacokinetics

null

2

arm 1: Baseline quinine sulfate pharmacokinetics arm 2: Quinine sulfate pharmacokinetics in the presence of steady state ciprofloxacin

[ 1, 0 ]

3

[ 0, 0, 0 ]

intervention 1: A single dose of quinine sulfate (2 x 324 mg capsules) administered on the morning of Day 1 after an overnight fast of at least 10 hours. intervention 2: A single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet) in the morning on Day 11 after an overnight fast of at least 10 hours. intervention 3: A single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet) in the morning on Day 11 after an overnight fast of at least 10 hours.

intervention 1: Quinine Sulfate Capsules 324 mg intervention 2: Ciprofloxacin 500 mg intervention 3: Quinine Sulfate Capsules 324 mg

0

null

0

NCT00785980

[ 2 ]

27

RANDOMIZED

PARALLEL

2DIAGNOSTIC

2DOUBLE

true

1FEMALE

null

This study will develop a model for the assessment of successful activation/engagement of estrogen receptor beta using salivary biomarkers.

null

Postmenopause

Biomarkers of estrogen receptor beta activation

null

3

arm 1: Placebo arm 2: Estrace 0.5 mg arm 3: Estrace 2 mg

[ 2, 1, 1 ]

2

[ 0, 0 ]

intervention 1: placebo capsule once daily for 7 days. intervention 2: Estrace 0.5 mg or 2 mg tablets once daily for 7 days.

intervention 1: Comparator: placebo intervention 2: Comparator: Estrace

0

null

0

NCT00799708

[ 3 ]

7

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

To determine the effects of topically applied ViaNOx-H for 8 hours daily for 2 weeks on the reduction of the bio-burden in biofilms on chronic non-healing wounds as recorded by measurements of wound size and wound culture.

The primary goal of this study is to determine the effects of topically applied gaseous nitric oxide on the bio-burden of chronic non-healing wounds of the lower extremities. Reports will include: * Comparisons of the demographics and diagnoses of those patients treated with ViaNOx-H. * Tabulation as to the organisms found and the bio-burden as measured by counts (0 to +4). * Tabulation of the number and types of adverse events during ViaNOx-H treatment. * Comparisons of the response of different organisms to ViaNOx-H treatment.

Chronic Ulcer of Lower Extremity

chronic cutaneous ulcers Nitric Oxide topically applied Biofilm Colonized chronic non-healing ulcers

null

1

arm 1: Topically applied Nitric Oxide for 8 hours daily for 2 weeks.

[ 0 ]

1

[ 0 ]

intervention 1: Topically applied gaseous nitric oxide at 8 to 10 parts per million, for 8 hours each night for 14 nights.

intervention 1: Nitric Oxide

1

Loma Linda | California | United States | -117.26115 | 34.04835

0

NCT00823095

[ 5 ]

165

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

Comparison of the safety and efficacy of Tazarotene Cream 0.1% compared with Adapalene Gel 0.3% in treating moderate to severe facial acne vulgaris

null

Acne Vulgaris

null

2

arm 1: 1 pea-size amount, QD x 16 weeks arm 2: 1 pea-size amount, QD x 16 weeks

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: 1 pea-size amount, QD x 16 weeks intervention 2: 1 pea-size amount, QD x 16 weeks

intervention 1: Tazarotene Cream 0.1% intervention 2: Adapalene

1

Fremont | California | United States | -121.98857 | 37.54827

0

NCT00829049

[ 5 ]

24

RANDOMIZED

SINGLE_GROUP

null

0NONE

true

0ALL

false

The purpose of this study is to provide anidulafungin and voriconazole to healthy subjects to determine the drug concentration in the lung.

null

Aspergillosis Candidemia

PK fungal infection

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Subjects will be admitted to the clinical research unit on Day 0. Subjects will receive anidulafungin intravenously in a loading dose of 200 mg on Day 1, followed by maintenance doses of 100 mg Q24h on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects will receive voriconazole in a loading dose of 6 mg/kg Q12h on Day 1, followed by a maintenance dose of 4 mg/kg Q12h on Day 2, and a 4 mg/kg morning dose on Day 3.

intervention 1: anidulafungin and voriconazole

1

Hartford | Connecticut | United States | -72.68509 | 41.76371

0

NCT00940017

[ 0 ]

15

RANDOMIZED

CROSSOVER

9OTHER

2DOUBLE

false

0ALL

true

The study is designed to assess if spinal cord injury patients have reduced pain after taking either pregabalin or placebo in a cross over design. Patients had either pain at the level of their injury or below the level of their injury.

This methodology study was terminated on October 13, 2008 based on interim results for an exploratory, novel endpoint. The results of the primary analysis at the interim for N=12 patients showed results that generally favored pregabalin but were not statistically significant compared to placebo. Based on the estimated conditional power, this result is unlikely to change with full recruitment of N=24 patients and therefore the data monitoring committee recommended termination of the trial. The decision to terminate the trial was not based on any safety concerns.

Spinal Cord Injuries

Clinical Trial Methodology study Neuropathic pain in Spinal cord injury patients Pain endpoints Crossover design

null

2

arm 1: None arm 2: None

[ 0, 5 ]

2

[ 0, 0 ]

intervention 1: Pregabalin 150mg capsules BID for 7.5 days intervention 2: Placebo capsules BID for 7.5 days

intervention 1: Pregabalin intervention 2: Placebo for pregabalin

4

0

NCT00978341

[ 0 ]

15

RANDOMIZED

CROSSOVER

null

2DOUBLE

false

0ALL

true

Overview of Protocol: Between Subject - Repeated Measures design will be used to assess the airway response of two groups of subjects under two different sedated conditions. Each group will be comprised of six subjects and will be categorized according to their baseline profile for risk for SDB (\< 10 RDI or \> 25 RDI). Some subjects will have been prescribed continuous positive airway pressure (CPAP) therapy by their treating physician as a result of their overnight sleep study. CPAP treatment is effective in splinting the airway open and thus decreasing the incident of airway collapse during sleep. Thus, CPAP utilization will also be tracked as an independent and continuous variable as regular CPAP use has been found to be associated with increased resistance to UAC (upper airway collapse). The experimental conditions will evaluate upper airway patency and instability in response to two forms of intravenous sedation: propofol and dexmedetomidine. Subjects will be continuously monitored during each experimental condition for respiratory effort and flow, and for EEG, EMG, and ECG. Respiratory instability will first be assessed while subjects are under sedation without any airway provocation. The degree of respiratory instability will be quantified in terms of the following measurements: a modified Respiratory Disturbance Index (RDIsedated), respiratory arousals, and minute ventilation. The apneic periods will be classified by their mixture of central and obstructive components.All outcome measurements are assessed over the period of sedation which last for approximately one hour. Upper airway patency will be quantified in terms of the critical pharyngeal pressure (Pcrit) (the pressure beyond which complete upper airway collapse occurs, see background).

The propensity to experience sleep disordered-breathing (SDB) is controlled by the interplay of anatomic factors (i.e. BMI, neck circumference, retrognathia) and neurological drive (sleep stage, arousal). The interaction of baseline anatomic factors and drug-induced altered neurologic drive may also convey a risk for upper airway collapse (UAC) in patients receiving analgesics, or sedation/anesthesia.1;2 While there is mainly only anecdotal evidence to support the proposition that SDB is a strong predictor of sedation-related adverse events,3;4 there is such a remarkable consensus of opinion regarding this association that, for example, the American Society of Anesthesiologists is developing guidelines to specifically address the issue of managing this group of "at risk" patients who are to undergo sedation or anesthesia. SDB is a term that is used to describe a spectrum of sleep-related breathing disturbances. Obstructive Sleep Apnea (OSA) is a condition that incorporates SDB with daytime symptoms (i.e. hypersomnolence). These terms are commonly used interchangeably. At this juncture, what is needed are clear demonstrations: 1) that SDB confers risk for sedation-related adverse events (epidemiologically and/or experimentally), 2) of the patient and drug factors that moderate/mediate the risk, and 3) of the mechanisms responsible for the patient by drug interactions. This proposed project will, in a preliminary way, address the first and second of these issues. Specifically, the upper airway characteristics of patients with different severity classifications of SDB will be assessed while under the influence of two, neuropharmacologically distinct, intravenous sedatives.

Obstructive Sleep Apnea

null

2

arm 1: Is an alkylphenol, is primarily indicated for use as a general anesthetic and has minimal analgesic properties. arm 2: Dexmedetomidine is an alpha-2 adrenoreceptor agonist that has sedative, hypnotic, and analgesic effects.

[ 5, 5 ]

2

[ 0, 0 ]

intervention 1: For propofol, the current study will employ the Marsh parameters, with an initial effect site target concentration of 1.0 mcg/ml, a level likely to produce only mild sedation. Though our patient population is expected to be predominantly obese, a previous pharmacokinetic study has validated that constant infusions utilizing the dosing scheme of mcg-1•kg-1•min will yield similar effect site concentrations.25 The effect site target will be increased in increments approximately every five minutes until the pharmacodynamic targets defined in the study are attained. intervention 2: For dexmedetomidine, an intravenous loading dose of 0.5 mcg/kg will be infused over 10 minutes and followed by an infusion starting at 0.5 mcg/kg/hr. This infusion will be titrated up to a maximum of 1.2 mcg/kg/hr.

intervention 1: Propofol intervention 2: Dexmedetomidine

1

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

0

NCT01045122

[ 4 ]

583

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to determine if a new formulation of ketoconazole 2% cream is as effective as a current formulation of ketoconazole 2% cream (Nizoral) compared with placebo in treating patients with Tinea pedis, a skin infection commonly known as "athlete's foot" that is caused by a kind of mold called a fungus.

This is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient knows the name of the assigned treatment), multicentre study in Poland and the United Kingdom designed to assess the mycological (fungal) cure rate and clinical efficacy of a new formulation of ketoconazole 2% cream (F126) with the current formulation of ketoconazole 2% cream (Nizoral) (F012) compared with placebo cream in patients with symptomatic uncomplicated interdigital (between the toes) Tinea pedis, a skin infection commonly known as "athlete's foot" that is caused by a kind of mold called a fungus. Approximately 548 patients who have symptomatic uncomplicated interdigital Tinea pedis confirmed by positive potassium hydroxide (KOH) microscopy (examination using a microscope) and mycological (fungal) culture will be randomized to receive 1 of 2 formulations of ketoconazole 2% cream (formulation F012 or F126) or placebo cream. There will be 4 study visits during the study. At Visit 1 (baseline), patients will sign the informed consent and be assessed for mycological and clinical signs and symptoms of Tinea pedis. Baseline demographics (age, race, etc), medical history and medication (s) that the patient is currently taking will be recorded. Patients will be issued with a tube of the cream and instructed to apply the cream sparingly to all affected areas of the foot (or feet), once daily (at night or in the evenings) for a total of 4 weeks according to protocol-specified guidelines. During the 4-week treatment period patients will return to the study every 2 weeks to be assessed for clinical signs and symptoms. After the 4-week treatment period, patients will continue participation in the study for an additional 2 weeks without medication. Patients will return then return to the study center for a final visit (Visit 4, Week 6) at which time skin scrapings will be sampled from interdigital spaces on both feet for KOH microscopy and mycological culture. The primary efficacy endpoint is to determine whether a new formulation of ketoconazole 2% cream is equivalent (or as effective) as the current formulation of ketoconazole 2% cream (Nizoral) compared to a placebo cream in achieving a mycological cure (defined as negative KOH microscopy and negative mycological culture) following 4 weeks of treatment. The primary outcome measure in the study is a mycological cure (defined as negative KOH microscopy and negative mycological culture) at week 6. Patients will be monitored for safety (occurrence of adverse events, use of concomitant medications, and reasons for premature discontinuation from the study) from Visit 1 through Visit 4 (Week 6 or time of early termination from study). Patients will be provided with up to two 15g tubes of ketoconazole cream (formulation F126 or F012) or matching placebo cream and be instructed to apply cream sparingly to affected areas of the feet once daily at night or in the evening for 4 weeks according to protocol specified guidelines.

Tinea Pedis

Tinea Pedis Ketoconazole (NIZORAL) Antifungal Agents Miconazole (DAKTARIN)

null

3

arm 1: ketoconazole 2% cream (formulation F126) A topical white homogenous cream containing the equivalent of 20 mg (or 2%) of ketoconazole applied sparingly to all affected areas of the foot (or feet) once daily (at night or in the evenings) for a total of 4 weeks. arm 2: ketoconazole 2% cream (formulation F012) (Nizoral) A topical white homogenous cream containing the equivalent of 20 mg (or 2%) of ketoconazole identical in appearance to study drug applied sparingly to all affected areas of the foot (or feet) once daily (at night or in the evenings) for a total of 4 weeks. arm 3: Placebo cream A topical white homogenous cream identical in appearance to study drug applied sparingly to all affected areas of the foot (or feet) once daily (at night or in the evenings) for a total of 4 weeks.

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: A topical, white, homogenous cream identical in appearance to study drug applied sparingly to all affected areas of the foot (or feet), once daily (at night or in the evenings) for a total of 4 weeks. intervention 2: A topical, white, homogenous cream containing the equivalent of 20 mg (or 2%) of ketoconazole identical in appearance to study drug applied sparingly to all affected areas of the foot (or feet), once daily (at night or in the evenings) for a total of 4 weeks. intervention 3: A topical, white, homogenous cream containing the equivalent of 20 mg (or 2%) of ketoconazole applied sparingly to all affected areas of the foot (or feet), once daily (at night or in the evenings) for a total of 4 weeks.

intervention 1: Placebo cream intervention 2: Ketoconazole 2% cream (formulation F012) (Nizoral) intervention 3: Ketoconazole 2% cream (formulation F126)

11

Bydgoszcz | N/A | Poland | 18.00762 | 53.1235 Lodz | N/A | Poland | 19.47395 | 51.77058 Lublin | N/A | Poland | 22.56667 | 51.25 Torun | N/A | Poland | 18.59814 | 53.01375 Cardiff | N/A | United Kingdom | -3.18 | 51.48 Chorley | N/A | United Kingdom | -2.61667 | 53.65 Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 Liverpool | N/A | United Kingdom | -2.97794 | 53.41058 Manchester | N/A | United Kingdom | -2.23743 | 53.48095 Reading | N/A | United Kingdom | -0.97113 | 51.45625 Sunbury-on-Thames | N/A | United Kingdom | -0.41817 | 51.40424

0

NCT01110330

[ 2 ]

19

RANDOMIZED

CROSSOVER

null

2DOUBLE

true

2MALE

false

Human experimental pain models are useful in understanding the mechanisms underlying clinical pain conditions and can be used to test the analgesic efficacy of drugs used in the management of pain. Once established these models can be used as mechanism biomarkers in early development clinical studies to establish proof of mechanism for novel compounds. The cold pain model is a mechanistic pain biomarker with potential application in proof of mechanism studies. In this study we aim to set up this cold pain model at a Clinical Research Unit and demonstrate we can effectively screen subjects for this model and examine the effect of morphine, diphenhydramine, and gabapentin in the cold pain model.

Cold pain methodology development

Healthy

Cold pain methodology Healthy male volunteers gabapentin Diphenhydramine morphine

null

4

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

[ 1, 1, 1, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Capsule, single 1200mg dose intervention 2: Tablet, single 50mg dose intervention 3: IV, single 10mg dose intervention 4: Placebo formulations (Capsule, tablet, IV to match the active treatments and to be administered in a double-dummy fashion).

intervention 1: Gabapentin intervention 2: Diphenhydramine intervention 3: Morphine intervention 4: Placebo

1

Brussels | N/A | Belgium | 4.34878 | 50.85045

0

NCT01119222

[ 4 ]

420

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

This study uses a randomized, double-blind, controlled design to demonstrate that PN400 (esomeprazole and naproxen) is more effective in reducing the occurrence of gastroduodenal ulcers, dyspepsia, and heartburn in subjects at risk for developing NSAID-associated gastric ulcers compared to naproxen alone.

Objectives: Primary: To demonstrate that PN400 is effective in reducing the risk of gastric ulcers in subjects at risk for developing NSAID-associated gastric ulcers. Secondary: * To determine if PN400 is effective in reducing the risk of duodenal ulcers in subjects at risk for developing NSAID-associated ulcers * To compare upper gastrointestinal symptoms in subjects treated with PN400 versus naproxen as measured by scores on the Severity of Dyspepsia Assessment (SODA) instrument and the Overall Treatment Evaluation - Dyspepsia (OTE-DP) * To compare heartburn symptoms in subjects treated with PN400 versus naproxen * To evaluate the safety and tolerability of PN400 and naproxen

Gastric Ulcer

NSAID gastric ulcers Vimovo Esomeprazole Naproxen

null

2

arm 1: Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily arm 2: Naproxen 500 mg dosed twice daily

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: PN400 tablets (Naproxen 500 mg and Esomeprazole 20 mg) twice daily (bid) taken orally. intervention 2: Naproxen 500 mg dosed twice daily (bid) orally

intervention 1: PN400 (VIMOVO) intervention 2: Naproxen

0

null

0

NCT01129011

[ 2 ]

48

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

true

0ALL

false

The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS 8mg with Zofran ODT® (Containing Ondansetron 8 mg) in healthy, male and female adult, human study participants under fed conditions. The purpose is to monitor clinical status, adverse events, laboratory investigations and to assess relative safety and tolerance of ondansetron formulations under fed conditions.

An open-label randomized, single oral dose, two way crossover bioequivalence study to compare ondansetron Orally Dissolving FilmStrip (ODFS) 8mg with Zofran Orally Disintegrating Tablets \[ODT® (Containing Ondansetron 8 mg)\] in 48 healthy, adult, human study participants under fed conditions. Volunteers who signed the consent form and showed their willingness to participate in the study were enrolled. Volunteers who satisfied the inclusion and exclusion criteria and found to be healthy on physical examination with laboratory investigation values within reference limits were considered eligible to be admitted into the study. Study participants were fasted for 10 hours prior to dosing in both periods. Dosing was conducted as per the randomization schedule in each period under fed conditions.A washout period of 7 days was observed between the two periods.

Healthy

null

2

arm 1: single dose of Ondansetron Orally Dissolving Filmstrip 8 mg arm 2: Single dose of Zofran (Ondansetron) ODT Orally Disintegrating Tablets 8 mg

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Ondansetron Orally Dissolving Filmstrip Ondansetron (ODFS) intervention 2: Ondansetron Orally Disintegrating Tablet Ondanestron (ODT)

intervention 1: Ondansetron (ODFS) intervention 2: Ondansetron (ODT)

1

Adyār | Chenni | India | 74.92257 | 12.87033

0

NCT01217801

[ 3, 4 ]

179

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and an α-glucosidase inhibitor administered once daily (QD) or three times daily (TID) for 40 consecutive weeks in participants who completed a phase 2/3 α-glucosidase inhibitor add on study.

Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus. Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes. "To evaluate the long-term safety and efficacy of alogliptin and an α-glucosidase inhibitor, this extension study was administered for 40 consecutive weeks (52 weeks from the start of treatment in the phase 2 dose-ranging study) to participants who completed a phase 2/3 α-glucosidase inhibitor add on study 322/CCT-003 (NCT01263483).

Type 2 Diabetes Mellitus

Diabetes Mellitus - Type 2 Diabetes Mellitus Drug Therapy

null

2

arm 1: None arm 2: None

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.

intervention 1: Alogliptin and voglibose intervention 2: Alogliptin and voglibose

0

null

0

NCT01263509

[ 3, 4 ]

339

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily (QD) combined with a thiazolidine taken QD in type 2 diabetic patients with uncontrolled blood glucose.

Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus. Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes. The present study was planned to evaluate the efficacy and safety of alogliptin as an add-on to pioglitazone in type 2 diabetic patients with uncontrolled blood glucose despite treatment with pioglitazone as well as diet and exercise therapies.

Type 2 Diabetes Mellitus

Diabetes Mellitus - Type2 Diabetes Mellitus Drug Therapy

null

3

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

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks. intervention 3: Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.

intervention 1: Alogliptin and pioglitazone intervention 2: Alogliptin and pioglitazone intervention 3: Pioglitazone

0

null

0

NCT01318070

[ 4 ]

218

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

1FEMALE

false

The purpose of this study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from vaginal atrophy.

null

Vaginal Atrophy

Vulvar/vaginal atrophy Atrophic Vaginitis Dehydroepiandrosterone DHEA Prasterone Vaginorm Menopause Intrarosa

null

4

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

[ 2, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks. intervention 2: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks. intervention 3: Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks. intervention 4: Vaginal suppository containing 1.0% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.

intervention 1: Placebo intervention 2: DHEA (0.25%) intervention 3: DHEA (0.5%) intervention 4: DHEA (1.0%)

8

0

NCT01846442

[ 2 ]

41

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This study will evaluate the safety, tolerability, efficacy and pharmacokinetics of aripiprazole intramuscular (IM) depot multiple doses every 4 weeks in adult patients with schizophrenia.

null

Schizophrenia

null

3

arm 1: 400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14. arm 2: 300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14. arm 3: 200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.

[ 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: Aripiprazole IM depot supplied as 200 mg or 400 mg vials of lyophilized aripiprazole powder to prepare for IM injection. intervention 2: Aripiprazole tablets 10 mg once daily in the morning for 14 days.

intervention 1: aripiprazole IM depot intervention 2: aripiprazole tablets

7

0

NCT01870999

[ 2 ]

2

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This trial was intended to investigate the pharmacokinetics, safety and tolerability of BI 201335 NA soft-gel capsules in patients with compensated liver cirrhosis, i.e. grade A according to Child-Pugh classification (\< 7 points).

null

Hepatitis C Liver Cirrhosis

null

1

arm 1: BI 201335 two single oral doses, separated by 14 days washout period

[ 0 ]

1

[ 0 ]

intervention 1: single oral doses

intervention 1: BI 201335

1

Mainz | N/A | Germany | 8.2791 | 49.98419

0

NCT01909778

[ 5 ]

40

RANDOMIZED

PARALLEL

1PREVENTION

1SINGLE

true

0ALL

false

It is important to wake up without any problem and comfortably from the general anesthesia. The aim of this study is to investigate the effects of addition dexmedetomidine to the balanced intravenous anesthesia with propofol over the cognitive functions and also it is considered that the addition of dexmedetomidine would reduce the use of anesthetics drugs in TİVA. Together with this effects, it has been considered that the disorder of the cognitive functions in postoperative period and the need for anesthetic drugs in postoperative period will be less. After the approval of the Ethics Committee and the patients being informed and taking informed consent from them 18 female 23 male totally 41 patients between the age of 20-60 years old, who had lumbar disc hernia, under general anesthesia have been taken under the study. The patients have been divided into two groups by closed envelope drawing method, randomly. All patients cognitive functions were evaluated by MMSE (Mini Mental State Examination) during the premedication visit. For this study group Standardized Mini Mental Test Examination (SMMT-E) were used, which has quite practical usage, for the untrained patients, and test composed of question-answer in order to calculate the remembering, caution and calculation structure and the scores were recorded. All patients had received the same anesthesia induction with propofol infusion (started at firstly 12 mg. kg-1 for the 30 minutes, the second 30 minutes 9 mg. kg-1 and the BIS(bispectral index) values were arranged between 40-60 until the end of the operation), and remifentanil infusion (0.5 μg.kg-1 was applied as opioid and was arranged according to the tension artery and heart rate). In the dexmedetomidine group, dexmedetomidine infusion had started as 0.5 μg.kg-1 without making the loading dose and the dose change was not made. Rocuronium 0.5 mg. kg-1 iv. was applied for the endotracheal intubation. After the operation all patients have taken to the recovery room. Then the tests of cognitive function evaluation were repeated as postoperative 2nd hour, 24 hours, 1 week and 1 month.

After the approve of the Ethics Committee and the patients were informed and taken informed consent form from them (18 female and 23 male) totally 41 patients between the age of 20-60 years old, who had lumbar disc hernia, under general anesthesia have been taken under the study. The patients with hepatic, renal or neurological diseases and using sedative- hypnotic, anticonvulsive and stimulant drugs and pregnant patients were excluded. Then they have been divided into two groups by closed envelope drawing method randomly and were allowed to stay hungry at least 8 hours. All the patients were applied the cognitive functions during the premedication visit MMSE (Mini Mental State Examination) that has quite practical usage and the test called Standardized Mini Mental Test Examination(SMMT-E) for the untrained persons. Test composed of question-answer in order to calculate the remembering, caution and calculation structure. All patients SMMTE scores were recorded. In the operation room, patients were applied the standard D-II derivation electrocardiography, heart beat rate, non-invasive arterial pressure, peripheral oxygen saturation (SpO2) and Bispectral Index (BİS) monitorization. Serum sale infusion was started by opening the vascular access with 18-20 gauge cannula. The skin of forehead and the temporal side were cleaned with alcohol cotton for the BİS monitorization. The electrode in the proximal part of the three electrodes of disposable BİS sensor was adhered to the middle of the forehead; the distal electrode to the temporal area on the eye line and the other electrode in between them both were adhered. The BİS values (BİS Monitor, Aspect, USA) were continuously monitored. The Group I (TİVA, n= 20) were received propofol-remifentanil and the Grup II (TİVA+D, n= 20) propofol- remifentanil and additional dexmedetomidine infusion. Induction of propofol infusion in all two groups was started as firstly 12 mg. kg-1 for the 30 minutes, the second 30 minutes 9 mg. kg-1 and the BIS values were arranged between 40-60 until the end of the operation. At the same time remifentanil infusion 0.5 μg.kg-1 was applied as opioid and arranged according to the tension artery and heart rate. The dexmedetomidine infusion has been started as 0.5 μg.kg-1 without making the loading dose and the dose change was not made. Rocuronium 0.5 mg. kg-1 iv. was applied for the endotracheal intubation. After intubation the carbon dioxide concentration was recorded in all periods. The patients were ventilated mechanically after the intubation in order to be ETCO2 (end-tidal carbon dioxide) 30-44 mmHg, tidal volume 8-10 mL. kg-1 . In case of tachycardia or hypertension the opioid dose was reduced in case of bradycardia or hypertension while the opioid dose was being increased. Propofol infusion was arranged to be kept in between BİS score 40-50. The effect of the used muscle relaxant was returned by neostigmine 0,05- 0,07 mg. kg-1 i.v. and atropin 0,03 mg. kg -1 i.v. After the operation all patients have been taken to the recovery room. Then the tests of cognitive function evaluation were repeated as postoperative 2nd hour, 24 hours, 1 week and 1 month.

Postoperative Confusion

Dexmedetomidine cognitive functions MMSE

null

2

arm 1: Only propofol (started as firstly 12 mg. kg-1 for the 30 minutes, the second 30 minutes 9 mg. kg-1) and remifentanil infusion (0.5 μg.kg-1) and rocuronium for intubation arm 2: Propofol started as firstly 12 mg. kg-1 for the 30 minutes, the second 30 minutes 9 mg. kg-1) and remifentanil infusion (0.5 μg.kg-1),and also dexmedetomidine infusion (started as 0.5 μg.kg-1 without making the loading dose and the dose change was not made during the operation) and rocuronium for intubation

[ 2, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: In case of tachycardia or hypertension the opioid dose was reduced, in case of bradycardia or hypertension the opioid dose was increased intervention 2: BIS values were arranged 40-60 until the end of operation intervention 3: 0.5 microgram/kg infusion, no changes intervention 4: 0.5 mg/kg iv for intubation, no changes

intervention 1: Remifentanil intervention 2: Propofol intervention 3: Dexmedetomidine intervention 4: Rocuronium

1

Bursa | N/A | Turkey (Türkiye) | 29.06013 | 40.19559

0

NCT02631135

[ 4 ]

122

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The aim of the study was to evaluate the efficacy and safety of BF-200 ALA (Ameluz) used with photodynamic therapy (PDT) in patients suffering from actinic keratosis.

The treatment comprised of one PDT session. If 12 weeks after PDT all lesions were cleared the patient entered the follow-up period. In case of remaining lesions or not completely cleared lesions the patient received a second PDT on the same day. The final assessment was performed 12 weeks after the last PDT and the patient moved to the follow-up phase.

Actinic Keratosis

null

2

arm 1: Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin. arm 2: Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.

[ 2, 1 ]

2

[ 0, 0 ]

intervention 1: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation). intervention 2: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation).

intervention 1: Vehicle intervention 2: BF-200 ALA

0

null

0

NCT02799082

[ 3 ]

599

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.

A Randomized Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multicenter, Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder Twice Daily compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Persistent Asthma Symptomatic on Non-Steroidal, Asthma Therapy

Asthma

Adults Pharmacokinetics Pharmacogenetics Asthma Adolescents GW685698X

null

2

arm 1: None arm 2: None

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: GW685698X intervention 2: placebo comparator

intervention 1: GW685698X intervention 2: Placebo

149

0

NCT00603382

[ 2, 3 ]

48

RANDOMIZED

CROSSOVER

9OTHER

0NONE

true

0ALL

false

This was an open-label, balanced, two-treatment, two-period, randomized sequence crossover bioequivalence study with a 7-day washout between periods. Each treatment was administered after an overnight (10 hours) fast.

This was an open label, balanced, randomized, two-treatment, two-period, randomized sequence crossover study conducted in healthy adult male and female volunteers. Subjects checked into the study center on Day -1 of each study period at least 12 hours prior to dosing on Day 1. Subjects were served dinner between 8:00 pm to 8:30 pm to ensure minimum 10 hours fast prior to dosing in both periods. Subjects received the 2 treatments in a randomized order with a 7-day washout between the 2 periods. Treatment A: single dose of ondansetron ODFS 8 mg was orally administered, allowed to dissolve, swallowed with saliva, followed with 240 mL room temperature drinking water Treatment B: single dose of Zofran ODT (containing ondansetron 8 mg) was orally administered, allowed to dissolve, swallowed with saliva, followed with 240 mL room temperature drinking water

Nausea and Vomiting, Postoperative Nausea With Vomiting Chemotherapy-Induced

Bioequivalence, safety, and tolerability

null

2

arm 1: Single dose of Ondansetron Orally Dissolving Film Strip 8 mg followed by single dose of Zofran ODT® Orally Disintegrating Tablet containing Ondansetron 8 mg with 7 days washout between the 2 periods arm 2: Single dose of Zofran ODT® Orally Disintegrating Tablet containing Ondansetron 8 mg followed by single dose of Ondansetron Orally Dissolving Film Strip 8 mg with 7 days washout between the 2 periods

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Test Article intervention 2: Comparator

intervention 1: Ondansetron (ODFS) intervention 2: Zofran (ODT)

1

Adyār | Chennai | India | 74.92257 | 12.87033

0

NCT01217190

[ 4 ]

641

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on insulin or insulin/metformin combination therapy.

null

Type 2 Diabetes Mellitus

null

2

arm 1: sitagliptin arm 2: Placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: sitagliptin 100 mg tablet qd for a 24-wk treatment period. intervention 2: sitagliptin 100 mg Pbo tablet qd for a 24-wk treatment period.

intervention 1: sitagliptin phosphate intervention 2: Comparator : placebo (unspecified)

0

null

0

NCT00395343

[ 3 ]

89

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

The trial is conducted in order to evaluate the efficacy, safety and pharmacokinetics of BI 2536 in the treatment of unresectable advanced pancreatic cancer as first line or second line therapy. A secondary aim is to identify the most suitable dosage regimen for the further phase II and III clinical programme of BI 2536. To achieve this objective, two dosage regimens are compared in patients receiving first line therapy.

null

Pancreatic Neoplasms

null

2

arm 1: Day 1 arm 2: Day 1 - 3

[ 0, 0 ]

1

[ 0 ]

intervention 1: Intravenous Infusion

intervention 1: BI 2536

10

Vienna | N/A | Austria | 16.37208 | 48.20849 Celle | N/A | Germany | 10.08047 | 52.62264 Düsseldorf | N/A | Germany | 6.77616 | 51.22172 Essen | N/A | Germany | 7.01228 | 51.45657 Freiburg/Breisgau | N/A | Germany | N/A | N/A Hamburg | N/A | Germany | 9.99302 | 53.55073 Herne | N/A | Germany | 7.22572 | 51.5388 München | N/A | Germany | 13.31243 | 51.60698 Stuttgart | N/A | Germany | 9.17702 | 48.78232 Ulm | N/A | Germany | 9.99155 | 48.39841

1

NCT00710710

[ 4 ]

277

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study will compare repeated intermittent IV dosing of diclofenac in patient with moderate to severe post-surgical pain from elective orthopedic surgery.

The primary objective is to evaluate the analgesic efficacy and safety of three dosage levels of parenteral diclofenac in providing pain relief as compared to placebo or Ketorolac tromethamine.

Postoperative Pain

null

3

arm 1: DIC075V (IV diclofenac) arm 2: IV Ketorolac arm 3: Placebo

[ 0, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: IV Diclofenac q6h intervention 2: IV ketorolac q6h intervention 3: Placebo q6h

intervention 1: IV Diclofenac intervention 2: IV ketorolac intervention 3: Placebo

8

0

NCT00507026

[ 3 ]

492

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

To evaluate the efficacy, safety and tolerability of GSK372475 compared with placebo in the treatment of outpatients subjects with major depressive disorder to exhibit decreased pleasure, interest and energy.

null

Depressive Disorder

MDD flexible-dose Major Depressive Disorder paroxetine GSK372475

null

3

arm 1: GSK372475 1.0- 1.5 mg/day arm 2: Paroxetine 20-30 mg/day arm 3: Placebo to Match

[ 0, 0, 5 ]

3

[ 0, 0, 10 ]

intervention 1: GSK372475 1.0-1.5 mg/day intervention 2: Paroxetine 20-30 mg/day intervention 3: Placebo to Match

intervention 1: GSK372475 intervention 2: Paroxetine intervention 3: Placebo

33

Plovdiv | N/A | Bulgaria | 24.75 | 42.15 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Miramichi | New Brunswick | Canada | -65.50186 | 47.02895 Burlington | Ontario | Canada | -79.83713 | 43.38621 Markham | Ontario | Canada | -79.2663 | 43.86682 Mississauga | Ontario | Canada | -79.6583 | 43.5789 Providencia / Santiago | Región Metro de Santiago | Chile | N/A | N/A Santiago | Región Metro de Santiago | Chile | -70.64827 | -33.45694 Santiago | Región Metro de Santiago | Chile | -70.64827 | -33.45694 Los Yoses, San José | Provincia de San José | Costa Rica | -84.08489 | 9.93388 San José | N/A | Costa Rica | -84.08489 | 9.93388 Split | N/A | Croatia | 16.43915 | 43.50891 Zagreb | N/A | Croatia | 15.97798 | 45.81444 Angoulême | N/A | France | 0.15345 | 45.64997 Dole | N/A | France | 5.48966 | 47.09225 Élancourt | N/A | France | 1.9552 | 48.78421 Paris | N/A | France | 2.3488 | 48.85341 Toulouse | N/A | France | 1.44367 | 43.60426 Toulouse | N/A | France | 1.44367 | 43.60426 Nuremberg | Bavaria | Germany | 11.07752 | 49.45421 Hüttenberg | Hesse | Germany | 8.62189 | 50.51453 Dresden | Saxony | Germany | 13.73832 | 51.05089 Berlin | N/A | Germany | 13.41053 | 52.52437 Bangalore | N/A | India | 77.59369 | 12.97194 Bangalore | N/A | India | 77.59369 | 12.97194 Lucknow | N/A | India | 80.92313 | 26.83928 Mangalore | N/A | India | 74.85603 | 12.91723 Manipal | N/A | India | 74.78333 | 13.35 Milan | Lombardy | Italy | 9.18951 | 45.46427 Pisa | Tuscany | Italy | 10.4036 | 43.70853 Bialystok | N/A | Poland | 23.16433 | 53.13333 Chełmno | N/A | Poland | 18.4251 | 53.34855 Leszno | N/A | Poland | 16.57494 | 51.84034

1

NCT00420641

[ 3 ]

65

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

true

ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258) to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study.

ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258). The purpose of the study is to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study. The desired primary efficacy outcome will be a changes in vaginal bleeding from baseline to 14 months and 17 months on study drug. The total duration of the study is up to 24 months including transition times, off drug intervals, and follow-up visits). It is expected that over a 16 week on drug interval menses will subside and return after a 4-8 week off drug interval (ODI).

Uterine Fibroids

Uterine fibroids

null

3

arm 1: Two Proellex® 12.5 mg capsules once daily arm 2: One Proellex® 12.5 mg capsules once daily arm 3: Capsule once a day

[ 0, 0, 2 ]

1

[ 0 ]

intervention 1: 25 mg daily (two 12.5 mg capsules)

intervention 1: Proellex®

11

0

NCT00958334

[ 3 ]

45

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

false

0ALL

false

GSK961081 is a potent dual pharmacophore that demonstrates both antimuscarinic and beta-agonist pharmacology in preclinical studies, both pharmacologies being of long duration. If reproduced in man, GSK961081 has the potential to deliver a medicine that can be given once daily. The bronchodilatation after inhalation of single doses of GSK961081 alone and in the presence of the short acting beta agonist salbutamol and the short acting muscarinic antagonist, ipratropium bromide will be measured in this study. Any residual bronchodilatation post-inhalation of GSK961081 and demonstrated by addition of salbutamol or ipratropium bromide may provide an indirect assessment of the beta-agonist and antimuscarinic components of GSK961081

Pulmonary Disease, Chronic Obstructive

salbutamol, Chronic Obstructive Pulmonary Disease (COPD) GSK961081 muscarinic receptor antagonist, COPD ipratropium bromide, Asthma ß2-adrenergic agonist,

null

6

arm 1: 400 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3x 200 microgrammes at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing. arm 2: 1200 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 microgrammes at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing. arm 3: 400 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 microgrammes, 20 microgrammes and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing. arm 4: 1200 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 microgrammes, 20 microgrammes and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing. arm 5: 400 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing. arm 6: 1200 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.

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

2

[ 0, 0 ]

intervention 1: Inhaled GSK961081 administered via Dry Powder Inhaler. intervention 2: Inhaled GSK961081 adminisntered via dry powder inhaler.

intervention 1: 400 microgrammes GSK961081 intervention 2: 1200 microgrammes GSK961081

4

Wellington | N/A | New Zealand | 174.77557 | -41.28664 Chiang Mai | N/A | Thailand | 98.98468 | 18.79038 Khon Kaen | N/A | Thailand | 102.833 | 16.44671 Manchester | N/A | United Kingdom | -2.23743 | 53.48095

0

NCT00674817

[ 5 ]

5

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Treatment for 3.5-8 weeks with GH (0.05 mg/kg/day) +GLN+Diet, followed by continued compliance to the individualized oral diet and enteral GLN, will result in reduced volume of TPN infusion/week and/or reduced frequency of TPN infusions/week.

Long-term total parenteral nutrition (TPN) is a supportive, rather than curative, therapy for patients with severe short bowel syndrome (SBS). Because of the complications (liver and kidney dysfunction, bone demineralization, nutrient deficiencies, catheter sepsis) and costs (\>$100,000/ patient/year) associated with this therapy, researchers have attempted to identify a safe, cost-effective alternative treatment modality. Various surgical procedures (including bowel transplantation) have been explored; however, these options currently offer limited clinical efficacy and significant morbidity and mortality. In contrast, a non-invasive therapy utilizing a growth factor (growth hormone - GH) and a bowel-specific nutrient (glutamine - GLN) in combination with an individualized oral diet (GH+GLN+Diet) has recently been shown to significantly enhance nutrient absorption and eliminate or reduce TPN requirements in patients with severe SBS. This open-labeled, single-center trial with a total enrollment of 30 patients with severe SBS will examine the safety and effectiveness of a lower dose (0.05 mg/kg/day) of growth hormone. Thirty-two subjects have previously been studied at the Nutritional Restart Center in Massachusetts utilizing a higher dose (0.1 mg/kg/day) of growth hormone and identical treatment parameters as described in this protocol. The University of Nebraska Medical Center and the Nutritional Restart Center have agreed to pool the data from both studies and analyze the data according to the same primary efficacy variable. Subjects recruited to the lower-dose growth hormone group will be matched, using specific clinical criteria, to patients in the higher dose growth hormone group. The primary efficacy variable will be the change in volume of TPN infusion/week and frequency of TPN infusions/week at 6 months following discharge compared to baseline. After a 3 day, baseline evaluation at The Nebraska Medical Center to determine pre-treatment TPN requirements and to assess the specific indices of nutritional and hydration status and kidney and liver function, and physical functioning capacity, patients will begin to receive lower dose GH (0.05 mg/kg/day) in combination with GLN (30 grams/day, orally) and the individualized oral/enteral diet. Treatment will last for a minimum of 23 days and a maximum of 54 days. Duration of treatment will be tailored to the patients' individual needs (e.g., understanding and acceptance of the modified diet, successful weaning of TPN). Patients may return to their home to continue receiving the GH treatment, provided they are tolerating the GH injections and understand how to properly administer the injections.

Short Bowel Syndrome

Growth Hormone TPN Total Parenteral Nutrition Glutamine Short Bowel Syndrome Increase in absorption of small bowel.

null

1

arm 1: Compare the low and high dose effects of Growth Hormone from previously pooled patients (high dose) and UNMC patients (low dose).

[ 5 ]

1

[ 0 ]

intervention 1: dosage = 0.05mg/kg/day, in diluent for injection, once a day, for 23 - 54 days.

intervention 1: Growth Hormone

1

Omaha | Nebraska | United States | -95.94043 | 41.25626

0

NCT00742157

[ 3 ]

40

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This phase II trial studies how well depsipeptide (romidepsin) works in treating patients with metastatic or unresectable soft tissue sarcoma. Drugs used in chemotherapy, such as depsipeptide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PRIMARY OBJECTIVES: I. To estimate the response rates of metastatic or unresectable soft tissue sarcomas to single-agent depsipeptide. II. To estimate the time to progression of metastatic or unresectable soft tissue sarcomas to single-agent depsipeptide. III. To evaluate the scope and extent of acute toxicities associated with single-agent depsipeptide when given to patients with soft tissue sarcomas. OUTLINE: This is a multicenter study. Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR. After completion of study treatment, patients are followed up every 2 months.

Adult Alveolar Soft-part Sarcoma Adult Angiosarcoma Adult Epithelioid Sarcoma Adult Extraskeletal Chondrosarcoma Adult Extraskeletal Osteosarcoma Adult Fibrosarcoma Adult Leiomyosarcoma Adult Liposarcoma Adult Malignant Fibrous Histiocytoma Adult Malignant Hemangiopericytoma Adult Malignant Mesenchymoma Adult Neurofibrosarcoma Adult Rhabdomyosarcoma Adult Synovial Sarcoma Gastrointestinal Stromal Tumor Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Recurrent Adult Soft Tissue Sarcoma Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Stage III Adult Soft Tissue Sarcoma Stage IV Adult Soft Tissue Sarcoma

null

1

arm 1: Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.

[ 0 ]

1

[ 0 ]

intervention 1: DEP is administered at a dose of 13 mg/m2 as a 4-hour intravenous infusion in the outpatient setting.

intervention 1: romidepsin

0

null

0

NCT00112463

[ 2 ]

17

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

0NONE

true

1FEMALE

false

Study to evaluate the PK of 25 mg and 50 mg of Proellex from 2 different suppliers in the fed and fasting states.

This study is intended to evaluate the pharmacokinetic properties of two doses (25 mg and 50 mg) of Proellex® formulated with microcrystalline cellulose (MCC) from 2 different suppliers in the fed and fasting states.

Pharmacokinetics

PK Pharmacokinetics

null

5

arm 1: 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fed State arm 2: 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fasting State arm 3: 2, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fed State arm 4: 2, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fasting State arm 5: 2, 25 mg Proellex capsules formulated with SMCC microcrystalline cellulose Fasting State

[ 0, 0, 0, 0, 0 ]

1

[ 0 ]

intervention 1: 25 mg capsule administered once orally after subjects have been fed; 25 mg capsule administered once orally while subjects are fasting; 2, 25 mg capsules administered once orally after subjects have been fed; 2, 25 mg capsules administered once orally while subjects are fasting; and 2, 25 mg capsules administered once orally while subjects are fasting

intervention 1: Proellex

1

San Antonio | Texas | United States | -98.49363 | 29.42412

0

NCT00749879

[ 5 ]

49

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

false

0ALL

true

This is a research study designed to compare the single-dose efficacy of albuterol-hydrofluoroalkane-breath-actuated inhaler (HFA-BAI) and albuterol-HFA-metered-dose inhaler (MDI) in asthmatics with poor inhaler coordinating abilities.

null

Asthma

Asthma and Poor Coordinators of Asthma Inhalers

null

2

arm 1: Participants will receive single actuation of albuterol 90 micrograms (mcg), administered using BAI in treatment period 1 or 2. arm 2: Participants will receive single actuation of albuterol 90 mcg, administered using MDI in treatment period 1 or 2.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Inhalation Aerosols, 90 mcg, 1 dose per treatment period intervention 2: Inhalation Aerosol (Breath-Actuated), 90 mcg, 1 dose per treatment period.

intervention 1: Albuterol-HFA-MDI intervention 2: Albuterol-HFA-BAI

5

0

NCT00530062

[ 3 ]

27

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

false

The purpose of this study is to evaluate, in a first stage, the safety (incidence of cardiac toxicity) of Caelyx in combination with Trastuzumab and Docetaxel; and in a second stage, the tumor response rate of this regimen. This study will be conducted in approximately 30 centers. A total of approximately 70 to 95 subjects will be enrolled.

null

Breast Neoplasm

null

1

arm 1: Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx. Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab.

[ 0 ]

3

[ 0, 0, 0 ]

intervention 1: Stage 1: 25 subjects will be treated with Caelyx IV 30 mg/m\^2 on day 1, every 3 weeks Stage 2: 45 new patients will be treated at the recommended dose level (defined in the first step) on day 1, every 3 weeks. intervention 2: Stage 1 and Stage 2: Docetaxel 60 mg/m2 IV as 1-hour infusion, on day 1, every 3 weeks. intervention 3: Stage 1 and Stage 2: 4 mg/kg IV 90-minute infusion loading dose. Then 2 mg/kg IV weekly during 6 cycles (18 weeks).

intervention 1: Pegylated Liposomal Doxorubicin intervention 2: Docetaxel intervention 3: Trastuzumab

0

null

0

NCT00687440

[ 3 ]

215

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to determine whether MK-8435 (Org 25935) is more effective than placebo in improving negative symptoms in participants with schizophrenia who are concurrently treated with a stable dose of a second generation antipsychotic.

The primary features of schizophrenia are characterized by positive (irrational thoughts and/or behavior) and negative symptoms. Negative symptoms are the gross absence of normal behavior and emotions, and usually include a general lack of engagement, social withdrawal, and loss of goal-directed behavior. Negative symptoms may strongly affect daytime activities and quality of life. The effects of currently available antipsychotics on negative symptoms are not satisfactory and leave much room for improvement. MK-8435 (Org 25935) is an investigational drug that may help to correct the above characteristics of schizophrenia by facilitating the messenger function of an amino acid in the brain, called glutamate. Preliminary data suggest that lowered glutamate levels in schizophrenia are associated with a failure to activate relevant areas in the forebrain and with prominent negative symptoms.

Schizophrenia

Negative symptoms Glycine Uptake inhibitor Add-on treatment Second Generation Antipsychotic

null

3

arm 1: Participants will be maintained on a stable dose of Second Generation Antipsychotic (SGA) and receive 4-8 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) can be titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose must remain stable after Day 42 for the remainder of the study. arm 2: Participants will be maintained on a stable dose of SGA and receive 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) can be titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose must remain stable after Day 42 for the remainder of the study. arm 3: Participants will be maintained on a stable dose of SGA and receive matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Administered orally 2 times a day (BID) for a final concentration of 8-16 mg/day intervention 2: Matching placebo for MK-8435 (Org 25935) administered orally BID intervention 3: Administered orally BID for a final concentration of 24-32 mg/day

intervention 1: MK-8435 (Org 25935) 4-8 mg intervention 2: Placebo intervention 3: MK-8435 (Org 25935) 12-16 mg

0

null

0

NCT00725075

[ 2 ]

24

RANDOMIZED

CROSSOVER

9OTHER

0NONE

true

0ALL

null

The purpose of this study is to determine if taking Vyvanse with Prilosec OTC or Adderall XR with Prilosec OTC changes how quickly the drug is absorbed into the body and/or changes how much of the drug is absorbed into the body.

null

Healthy Volunteers

Drug Interaction Study

null

2

arm 1: None arm 2: None

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 50mg capsule intervention 2: 20mg capsule

intervention 1: Lisdexamfetamine Dimesylate intervention 2: Adderall XR (mixed salts amphetamine)

1

Miami | Florida | United States | -80.19366 | 25.77427

0

NCT00746733

[ 2 ]

12

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to determine the highest, tolerated dose level and safety of lapatinib, capecitabine and oxaliplatin in subjects with advanced cancer and to determine the clinical activity of the combination of drugs in subjects with previously untreated advanced or metastatic colorectal cancer.

null

Neoplasms, Colorectal

Metastatic Colorectal Cancer oxaliplatin fluoropyrimidines cancers Advanced Colorectal Cancer capecitabine lapatinib

null

2

arm 1: Dose escalation of lapatinib along with capecitabine and oxaliplatin until the maximum tolerated dose is reached. arm 2: Treatinng subjects at the maximum tolerated dose of lapatinib, capecitabine, and oxaliplatin

[ 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: onced daily Days 1-21 intervention 2: Day one of each cycle intervention 3: given BID days 1-14

intervention 1: lapatinib intervention 2: oxaliplatin intervention 3: capecitabine

1

Madison | Wisconsin | United States | -89.40123 | 43.07305

0

NCT00536809

[ 4 ]

4,150

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to see if it is effective to give HIV positive patients recombinant interleukin-2 (rIL-2) in addition to anti-HIV therapy. Patients will be followed over a minimum of 4 years to study the long-term effects of rIL-2 on their HIV disease progression. Anti-HIV therapy has been very successful in treating HIV positive patients and in keeping viral load (level of HIV in the blood) low. However, anti-HIV drugs cannot completely rid the body of the virus, and the immune system is never completely restored in HIV positive patients. Doctors hope that giving patients recombinant interleukin-2 (rIL-2) in addition to their anti-HIV therapy will help improve their immune systems and keep them healthier over a longer period of time. rIL-2 is a hormone naturally produced by the body during an immune response to a microbial infection.

Much progress has been made in implementing potent antiretroviral therapy that is able to maximally suppress viral replication. However, these drug combinations do not result in viral eradication and, for many patients, virologic and immunologic control cannot be maintained. Even among patients with apparent virologic control, a "ceiling effect" seems to exist with failure of CD4 cell counts to rise on average more than 100 to 150 cells/mm\^3, at least during the first 2 years of therapy. The incomplete recovery of immune function after initiation of therapy remains an obstacle in the management of HIV. Preservation of immune function by direct expansion of CD4 lymphocytes with rIL-2 could represent a significant additional treatment strategy. It also has been speculated recently that rIL-2 in combination with potent antiretroviral therapy may be a useful approach for purging HIV from the latently infected CD4 cells. It is hoped that intervention with rIL-2 therapy in combination with antiretroviral therapy at an early stage of HIV infection can prevent CD4 T-cell depletion and result in fewer AIDS-defining illnesses than with antiretroviral therapy alone. Patients are randomized to receive subcutaneous (SC) rIL-2 therapy or no rIL-2 therapy. All patients must be taking a regimen of combination antiretroviral treatment, with the choice of therapy at the discretion of the treating clinician. Antiretroviral medications are not provided by this study. Recombinant IL-2 is given SC for 5 consecutive days every 8 weeks for at least 3 cycles unless toxicities or other contraindications develop. After the first three cycles, additional cycles are given at the discretion of each patient's physician, with a general goal of maintaining the patient's CD4 cell count at twice the baseline level or at 1,000 cells/mm\^3 or above for as long as possible. Patients in the no rIL-2 group receive no injections. Patients in both treatment groups are seen every 4 months for follow-up data collection to monitor viral load and CD4 cell counts. All patients are followed for a minimum of 4 years. During the trial, patients in the no SC rIL-2 group are not given rIL-2 at any point. However, at the end of the study, if rIL-2 is found to be effective in reducing the rate of disease progression \[AS PER AMENDMENT 12/15/00: (new and recurrent events)\], including death, all patients are offered rIL-2.

HIV Infections

Recombinant Proteins Injections, Subcutaneous HIV-1 Interleukin-2 Drug Therapy, Combination CD4 Lymphocyte Count Disease Progression Follow-Up Studies Anti-HIV Agents

null

2

arm 1: Recombinant interleukin-2 (rIL-2) therapy used with combination anti-HIV medication of choice. arm 2: Control arm uses anti-HIV medication of choice without rIL-2.

[ 0, 4 ]

1

[ 0 ]

intervention 1: Recombinant interleukin-2 at a dose of 7.5 MIU given twice daily subcutaneously for 5 consecutive days every 8 weeks for at least 3 cycles.

intervention 1: Recombinant interleukin-2 (rIL-2)

248

1

NCT00004978

[ 4 ]

9,406

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

The purpose of this study is to see if early INTEGRILIN® (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention (surgery) compared to placebo (with delayed provisional use of eptifibatide).

This study will enroll patients who experience symptoms of acute coronary syndrome (experiencing chest pain at rest with episodes lasting at least 10 minutes) and who are planned to undergo invasive surgical procedures after being given study drug for 12 to 96 hours. There are two different treatment groups in this study; approximately half of the patients will go to each group and the likelihood of receiving study drug vs. placebo is 50/50 (like tossing a coin). Medications that are standard of care will be provided to the patients (all patients will be given aspirin and standard hospital doses of one of two other blood thinning drugs - unfractionated heparin (UFH) or low-molecular-weight heparin). Which one patients receive is at the discretion of the Investigator.

Myocardial Ischemia Acute Coronary Syndrome

myocardial infarction acute coronary syndrome non-ST-segment elevation eptifibatide Integrilin glycoprotein IIb/IIIa inhibitor (GP IIb/IIIa) percutaneous coronary intervention (PCI) coronary artery bypass graph surgery (CABG) catheterization angina ischemia cardiac ischemia cardiovascular disease

null

2

arm 1: Eptifibatide in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin. arm 2: Placebo in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: intravenous; 180 mcg/kg bolus followed by infusion of 2 mcg/kg/min for 12 to 96 hours (or longer if necessary to complete the 18- to 24-hour post-PCI infusion period, or up to 120 hours in patients who proceed to CABG \[coronary artery bypass graft\]); second bolus of 180 mcg/kg administered 10 minutes after first bolus. intervention 2: intravenous; delivery to match eptifibatide to maintain blind

intervention 1: Eptifibatide (Integrilin) intervention 2: Placebo

0

null

1

NCT00089895

[ 4 ]

747

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

false

0ALL

null

The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.

null

Parkinson's Disease

Parkinson's disease, levodopa therapy, dyskinesia

null

2

arm 1: Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks. arm 2: Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Carbidopa/Levodopa/Entacapone 12.5/50/200 mg and 25/100/200 mg capsules. intervention 2: Immediate release carbidopa/levodopa 12.5/50 mg and 25/100 mg capsules.

intervention 1: Carbidopa/levodopa/entacapone intervention 2: Immediate release carbidopa/levodopa

73

1

NCT00099268

[ 4 ]

154

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma.

null

Exercise Induced Asthma

null

2

arm 1: Period I - Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study. arm 2: Period I - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.

[ 0, 0 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Montelukast 5 mg chewable tablet once daily intervention 2: Salmeterol 50 mcg dry powder per actuation inhaled twice daily intervention 3: Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily intervention 4: Matching placebo to montelukast oral tablet administered once daily. intervention 5: Matching placebo to salmeterol dry powder for inhalation administered twice daily

intervention 1: Montelukast sodium intervention 2: Salmeterol xinafoate intervention 3: Fluticasone propionate intervention 4: Montelukast matching placebo intervention 5: Salmeterol matching placebo

0

null

1

NCT00127166