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

[ 5 ]

36

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

false

0ALL

false

The purpose of this study is to compare the vascular effects of two commonly used diabetes medications, rosiglitazone and glyburide in type 2 diabetic patients.

Rosiglitazone and glyburide are two commonly used diabetic medications that have both been shown to be effective in controlling blood glucose levels. Since they work in different ways, they may have different effects on the health of the blood vessels. This study will assess which medication is better at improving the health of the arteries separate from the blood glucose lowering effects. Artery health will be assessed non-invasively by ultrasound. Certain markers of atherosclerosis found in the blood will also be measured.

Type 2 Diabetes Mellitus

thiazolidinedione sulfonylurea endothelial function

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: rosiglitazone intervention 2: glyburide

1

Saint Paul | Minnesota | United States | -93.09327 | 44.94441

0

NCT00123643

[ 2, 3 ]

40

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study will test a combination of the drugs naltrexone and bupropion with weight-concerned smokers to investigate whether or not this combination of drugs improves smoking cessation quit rates and minimizes post quit weight gain.

This is an open label smoking cessation clinical trial of 25 mg naltrexone with 300 mg bupropion sustained-release (SR) in six male and fourteen female participants. This pilot study is being conducted to determine: * effect size estimates for smoking cessation and post-cessation weight gain, which will be used to compute the sample size needed for a large-scale clinical trial; and * compliance with a combination of 25 mg naltrexone and 300 mg bupropion SR. In addition to examining the sample in this study, the investigators plan to compare this sample to a sample of matched controls.

Smoking Nicotine Dependence

Tobacco Smoking Weight Weight perception Naltrexone Bupropion

null

2

arm 1: The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day). arm 2: The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment. intervention 2: Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.

intervention 1: Naltrexone intervention 2: Bupropion

1

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

0

NCT00129246

[ 5 ]

99

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

false

0ALL

false

The objective of this pilot study is to evaluate the efficacy of treatment with montelukast as compared to placebo in the prevention of recurrence of acute Otitis media (AOM)

Otitis media (OM) is one of the most common childhood disorders requiring physician care and has been associated with an alarming rise in prevalence. Certain children are prone to recurrent episodes of acute Otitis media (RAOM) and/or the development of chronic Otitis media with effusion (COME). Because medical therapy with antibiotics, antihistamines, decongestants and corticosteroids has no demonstrable efficacy, the mainstay of treatment is surgical intervention, which is quite expensive and exposes patients to risks of general anesthesia. The objective of this pilot study is to evaluate the efficacy of treatment with montelukast as compared to placebo in the prevention of recurrence of acute Otitis media (AOM)

Acute Otitis Media Otitis Media Ear Infection

Ear Infections Otitis Media

null

2

arm 1: Treatment with montelukast for 4 months (4 mg per day) arm 2: Treatment with placebo for 4 months

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Montelukast intervention 2: Placebo

2

0

NCT00189462

[ 4 ]

136

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of the study is to compare the overnight efficacy and plasma concentration-time profiles of armodafinil and PROVIGIL, after multiple doses, in patients with excessive sleepiness associated with chronic Shift Work Sleep Disorder (SWSD).

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL in Patients with Chronic Shift Work Sleep Disorder

Chronic Shift Work Sleep Disorder

null

5

arm 1: PROVIGIL 200 mg/day arm 2: Armodafinil 250 mg/day arm 3: Armodafinil 200 mg/day arm 4: Armodafinil 150 mg/day arm 5: Placebo

[ 0, 0, 0, 0, 2 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: PROVIGIL 200 mg/day intervention 2: Armodafinil 250 mg/day intervention 3: Armodafinil 200 mg/day intervention 4: Armodafinil 150 mg/day intervention 5: Matching placebo tablets

intervention 1: PROVIGIL 200 mg intervention 2: Armodafinil 250 mg intervention 3: Armodafinil 200 mg intervention 4: Armodafinil 150 mg intervention 5: Placebo

20

0

NCT00236080

[ 4 ]

224

RANDOMIZED

PARALLEL

9OTHER

0NONE

false

0ALL

null

To assess the change in hemoglobin levels when iron sucrose was added to a regimen of weekly, fixed doses of erythropoietin in patients who had or had not responded to erythropoietin therapy alone.

This was a two stage, randomized, controlled study of cancer patients undergoing or planning to undergo chemotherapy. After stage one, (where patients were exposed to an erythropoiesis stimulating agent), patients were randomized to receive either IV iron sucrose or no iron supplementation. Patients were then followed to safety and efficacy endpoints.

Anemia

Anemia Cancer Chemotherapy

null

4

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

[ 1, 1, 1, 1 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: iron sucrose injection USP intervention 2: stable erythropoietin therapy

0

null

0

NCT00236951

[ 4 ]

151

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

1FEMALE

null

Purpose of the study is the comparative evaluation of the clinical efficacy and of the general tolerability of two different subcutaneous FSH preparations (Fostimon® IBSA Vs Gonal-F® Serono) when administered in patients undergoing ICSI

This is a multicentric, prospective, randomised, investigator blind, controlled clinical trial (phase III) of two parallel groups, one receiving the test drug FSH (Fostimon® , IBSA) and the other the reference drug FSH (Gonal-F®, Serono). The groups will be paired on the major prognostic criteria. In effect, a double blind trial is not really feasible since the drugs presentations are very different. However, in IVF, drugs are usually dispensed and/or injected by a nurse and therefor the Investigator can be blind. Moreover, the used preparations will contain the same amount of gonadotrophin units (75 IU), will be repackaged in anonymous boxes and the following sentence will be written in the Patient Information Sheet: "You are required not to inform the Investigator about the product's name". The randomisation is necessary to get groups as comparable as possible for all the other aspects. The multicentric design has the double interest of facilitating the patients' recruitment and of decreasing the biases related to attitudes in a specific centre.

Infertility

Ovarian stimulation Infertility ICSI FSH

null

2

arm 1: Fostimon is an highly purified FSH preparation. arm 2: Gonal-F is a recombinant FSH preparation.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: subcutaneous injection of FSH. Starting dose: 225 IU. intervention 2: subcutaneous injection of FSH. Starting dose: 225 IU.

intervention 1: Follicle Stimulating Hormone intervention 2: Follicle Stimulating Hormone

7

Bron | N/A | France | 4.91303 | 45.73865 Lille | N/A | France | 3.05858 | 50.63297 Lyon | N/A | France | 4.84671 | 45.74846 Marseille | N/A | France | 5.38107 | 43.29695 Neuilly-sur-Seine | N/A | France | 2.26965 | 48.8846 Paris | N/A | France | 2.3488 | 48.85341 Budapest | N/A | Hungary | 19.04045 | 47.49835

0

NCT00335725

[ 5 ]

37

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This 6-month open label study will evaluate the long term safety of bosentan (via oxygen saturation) and efficacy (exercise capacity) in patients who have completed the BREATHE-5 study (PAH related to Eisenmenger physiology). Treatment duration is 6 months.

This is a multicenter, open-label, single -arm study with bosentan, initial dose of 62.5 mg b.i.d., with a target dose of 125 mg b.i.d. All patients will be assessed for eligibility during the baseline visit (same as Week 16, end of study BREATHE-5 visit), and will have the option to enter into the open-label extension study at a starting dose of 62.5 mg b.i.d., for safety reasons. Visit 2 is required as a safety visit to assess oxygen saturation (SpO2) after 1 week of bosentan treatment. Patients will return for Visit 4 after 4 weeks of treatment, and the dose will be up-titrated to 125 mg b.i.d. or maintained at 62.5 mg b.i.d. at the judgement of the investigator. Data will be collected for a total of 24 weeks or until the sponsor decides to stop the study. If the results from Study AC-052-403 or AC-052-405 demonstrate significant safety issues, this extension study may be terminated at the sponsor's request.

Pulmonary Arterial Hypertension

bosentan PAH related to Eisenmenger physiology Tracleer

null

1

arm 1: The starting dose for all patients will be 62.5 mg b.i.d. At the Week 4 visit, patients who were started on 62.5 mg b.i.d. will be uptitrated to 125 mg b.i.d. if the 62.5 mg b.i.d. dose was well-tolerated.

[ 0 ]

1

[ 0 ]

intervention 1: Patients will receive up to 125 mg b.i.d. of Tracleer.

intervention 1: Tracleer®

17

Boston | Massachusetts | United States | -71.05977 | 42.35843 Houston | Texas | United States | -95.36327 | 29.76328 Camperdown | N/A | Australia | 151.17642 | -33.88965 Victoria | N/A | Australia | N/A | N/A Vienna | N/A | Austria | 16.37208 | 48.20849 Leuven | N/A | Belgium | 4.70093 | 50.87959 Calgary | Alberta | Canada | -114.08529 | 51.05011 Toronto | Ontario | Canada | -79.39864 | 43.70643 Paris | N/A | France | 2.3488 | 48.85341 Bad Oeynhausen | N/A | Germany | 8.80365 | 52.20699 München | N/A | Germany | 13.31243 | 51.60698 Bologna | N/A | Italy | 11.33875 | 44.49381 Pavia | N/A | Italy | 9.15917 | 45.19205 Groningen | N/A | Netherlands | 6.56667 | 53.21917 Madrid | N/A | Spain | -3.70256 | 40.4165 Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 London | N/A | United Kingdom | -0.12574 | 51.50853

0

NCT00367770

[ 4 ]

114

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This is a randomized, double-blind, multicenter clinical phase III study involving about 105 cancer patients aged \>18 years who are receiving palliative chemotherapy and who are suffering from chemotherapy associated anemia. A standard treatment group (ERYPO®) will be included to provide a reference reflecting current standard medical practice.

Eligible patients were randomized to one of two different treatment groups (EPO HEXAL or ERYPO) in a 2:1 ratio. Patients received double-blind treatment for a period of 12 weeks. Following randomization the patients were treated subcutaneously with a dose of 150 IU/kg body weight of study drug three times per week. Dose adjustments to 300 IU/kg body weight three times per week were to be done if hemoglobin (Hb) increased \<1.0 g/dL or the reticulocyte count increased \<40,000 /μl after 4 weeks or if Hb increased \<2.0 g/dL after 8 weeks of treatment. The primary endpoint was the Hb response in the EPO HEXAL group during weeks 5-12 of the study defined as absolute increase in Hb value of 2.0 g/dL from the mean value of the screening/baseline period in the absence of red blood cell transfusion during the preceding 4 weeks. For that purpose, Hb levels were measured at the weekly study visits by a central laboratory. Further parameters of treatment efficacy, safety and tolerability were recorded.

Anemia

Chemotherapy associated anemia in cancer patients

null

2

arm 1: HX575 (erythropoietin alfa of the Sponsor Hexal AG). Eligible patients to be randomized in ratio 2:1 and to be subcutaneously treated (solution for injection (s.c.)) for 12 weeks with HX575 in pre-filled syringes. The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week. arm 2: ERYPO® Janssen-Cilag, Germany. Eligible patients were treated subcutaneously (solution for injection (s.c.)) with ERYPO® (Janssen-Cilag, Germany) in pre-filled syringes for 12 weeks.The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin intervention 2: 1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa

intervention 1: HX575, solution for injection (s.c.) intervention 2: ERYPO®, Janssen-Cilag, solution for injection (s.c.)

19

Augsburg | N/A | Germany | 10.89851 | 48.37154 Bad Soden | N/A | Germany | 9.36404 | 50.28857 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Freiburg im Breisgau | N/A | Germany | 7.85222 | 47.9959 Luckenwalde | N/A | Germany | 13.16772 | 52.09029 Munich | N/A | Germany | 11.57549 | 48.13743 Munich | N/A | Germany | 11.57549 | 48.13743 Nuremberg | N/A | Germany | 11.07752 | 49.45421 Stuttgart | N/A | Germany | 9.17702 | 48.78232 Stuttgart | N/A | Germany | 9.17702 | 48.78232 Tübingen | N/A | Germany | 9.05222 | 48.52266 Velbert | N/A | Germany | 7.04348 | 51.33537 Weiden | N/A | Germany | 12.15613 | 49.67682 Cluj-Napoca | N/A | Romania | 23.6 | 46.76667 Oradea | N/A | Romania | 21.91833 | 47.0458 Satu Mare | N/A | Romania | 22.86255 | 47.79926 Timișoara | N/A | Romania | 21.22571 | 45.75372

0

NCT00711958

[ 2 ]

22

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

0NONE

true

0ALL

false

The purpose of this study is to evaluate and compare the relative bioavailability of Quinine Sulfate capsules following a single, oral dose in healthy volunteers under fasting and fed conditions.

The purpose of this study is to evaluate and compare the relative bioavailability of Quinine Sulfate capsules following a single, oral dose in healthy volunteers under fasting and fed conditions. Twenty-two healthy, non-smoking, non-obese, male and female volunteers between the ages of 18 and 45 years of age will be randomly assigned in a crossover fashion to receive each of two Quinine Sulfate dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, subjects will receive either a single oral dose of Quinine Sulfate (2 x 324 mg capsules) following an overnight fast of at least 10 hours, or a single oral dose of Quinine Sulfate (2 x 324 mg capsules) 30 minutes after a standardized, high-fat breakfast. After a 7 day washout period, on the morning of Day 8, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 48 hours post-dose to adequately define the pharmacokinetics of Quinine Sulfate. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Blood pressure and heart rate will be measured prior to dosing and at 1, 2, 4 and 12 hours after each dose and at study exit. A 12 lead electrocardiogram (EKG) will be recorded at study check-in and at 2, 4, 6, 12 and 24 hours after dose administration. 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

Bioavailability

null

2

arm 1: A single dose of Quinine Sulfate (2 x 324 mg capsules) administered after an overnight fast of at least 10 hours. arm 2: A single dose of Quinine Sulfate (2 x 324 mg capsules) administered 30 minutes after a standardized, high fat breakfast.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Quinine Sulfate (2 x 324 mg capsules) administered after an overnight fast of at least 10 hours. intervention 2: Quinine Sulfate (2 x 324 mg capsules) administered 30 minutes after a standardized, high fat breakfast.

intervention 1: Quinine Sulfate 2 x 324 mg Capsules intervention 2: Quinine Sulfate 2 x 324 mg Capsules

0

null

0

NCT00726414

[ 4 ]

351

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

This study was conducted to see if mometasone nasal spray is efficaceous for the treatment of perennial allergic rhinitis. Patients will be randomized to active mometasone, placebo mometasone, active fluticasone, or placebo fluticasone.

null

Perennial Allergic Rhinitis

null

4

arm 1: Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray arm 2: Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray arm 3: Mometasone furoate nasal spray 200 μg/day(QD) arm 4: Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)

[ 2, 2, 0, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Placebo to mometasone furoate nasal spray, indistinguishable from mometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks intervention 2: Placebo to fluticasone nasal spray, indistinguishable from fluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks intervention 3: Mometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks intervention 4: Fluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks

intervention 1: Placebo for MF intervention 2: Placebo for FP intervention 3: Mometasone intervention 4: Fluticasone

0

null

0

NCT00783224

[ 4 ]

31

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

null

This was a prospective, open, non-comparative study to evaluate the safety and efficacy of recombinant human luteinizing hormone (rhLH, Luveris) administered subcutaneously (s.c.) in follicular development during ovulation induction in 31 Chinese female subjects with hypogonadotropic hypogonadism.

The objective of this prospective, open, non-comparative study was to assess the safety and efficacy of rhLH (Luveris) administered subcutaneously in follicular development during ovulation induction in Chinese female subjects with hypogonadotropic hypogonadism. The study was organized on an outpatient basis involving a single cycle of treatment. Prior to entry into the study, the diagnosis of hypogonadotropic hypogonadism was confirmed by history, by the presence or absence of specific clinical features and by measuring serum gonadotropin levels. Once a subject has signed the informed consent form and after satisfying all eligibility criteria, the subject received a combination of daily injection of recombinant human follicle-stimulating hormone (rhFSH) 150 international units (IU) plus rhLH 75 IU. After adequate follicular response, ovulation induction was triggered by an injection of 10,000 IU human chorionic gonadotropin (hCG). Luteal phase function was assessed by serum progesterone level determination.

Hypogonadism

Hypogonadism Recombinant human follicle stimulating hormone (r-hFSH) Recombinant leutinizing hormone (r-hLH)

null

0

null

3

[ 0, 0, 0 ]

intervention 1: One r-hLH (75 International Units \[IU\]) injection s.c. once daily. intervention 2: One r-hFSH (150 IU) injection s.c. once daily. intervention 3: After adequate follicular response, ovulation induction was triggered by an injection of 10,000 IU hCG.

intervention 1: Recombinant human luteinizing hormone (r-hLH) intervention 2: Recombinant human follicle-stimulating hormone (r-hFSH) intervention 3: Human chorionic gonadotropin (hCG)

1

Beijing | N/A | China | 116.39723 | 39.9075

0

NCT01084265

[ 4 ]

337

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study was to assess the efficacy of Sativex in relieving symptoms of spasticity in multiple sclerosis

This was a 15 week (one week baseline and fourteen weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex in subjects with symptoms of spasticity due to multiple sclerosis. Eligible subjects entered a seven day baseline period. Subjects then returned to the centre for randomisation and dose introduction. Visits occurred at the end of treatment weeks two, six, ten and at the end of the study (treatment week 14) or earlier if they withdrew.

Multiple Sclerosis

null

2

arm 1: Active treatment arm 2: Control

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Contains delta-9-tetrahydrocannabinol (THC) (27mg/ml): cannabidiol (CBD) (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg:CBD 60 mg) in 24 hours. intervention 2: Contains peppermint oil flavouring, 0.05%(v/v); quinoline yellow,0.005% (w/v) and sunset yellow, 0.0025% (w/v) colourants, in a and ethanol:propylene glycol (50:50) excipient.

intervention 1: Sativex intervention 2: Placebo

1

Reading | N/A | United Kingdom | -0.97113 | 51.45625

0

NCT01599234

[ 4 ]

267

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

Determination of the effects of sildenafil citrate and epoprostenol when used in combination in patients with pulmonary arterial hypertension

null

Pulmonary Hypertension

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: Sildenafil citrate

52

1

NCT00159861

[ 3 ]

195

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to determine whether Xyrem (sodium oxybate) is effective when used alone to treat the pain and sleep disturbances of fibromyalgia.

Fibromyalgia affects millions of Americans, yet there are no FDA approved drugs to treat this debilitating condition. Besides causing pain, it also disrupts normal sleep patterns in many of its victims. Pain and lack of sleep reinforce each other, making patients progressively more miserable. Xyrem is a potent hypnotic that induces and consolidates sleep. In a few small studies Xyrem has been reported to offer relief to some fibromyalgia patients. This trial is designed to test this hypothesis. Patients who enroll in this study will stop taking any prescription medications for fibromyalgia (over-the-counter pain relievers will be permitted). They will then take either Xyrem alone or placebo alone. Patients will be followed for eight weeks to evaluate any relief of the pain or functional impairment of fibromyalgia from their study treatment. Sleep characteristics will also be assessed subjectively and by polysomnographic recordings at baseline and twice during the treatment phase.

Fibromyalgia

Fibromyalgia Pain

null

3

arm 1: Sodium oxybate 6.0 g per day. arm 2: Placebo (one of two doses matching active treatment by volume). arm 3: Sodium oxybate 4.5 g per day.

[ 0, 2, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Xyrem (sodium oxybate) oral solution 4.5 g per day in divided doses, 2.25 g at bedtime and another 2.5 g two and a half to four hours later for 8 weeks. intervention 2: Xyrem (sodium oxybate) oral solution 6.0 g per night in divided doses of 3 g at bedtime and 3 g at 2.5 to 4 hours later for 8 weeks. intervention 3: Placebo one of two doses matching active treatment by volume for 8 weeks.

intervention 1: Xyrem (sodium oxybate) oral solution intervention 2: Xyrem (sodium oxybate) oral solution intervention 3: Placebo

20

0

NCT00087555

[ 4 ]

685

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either 1.0 % AzaSite or Vehicle. Three visits will be required for this study.

null

Bacterial Conjunctivitis

Bacterial Conjunctivitis Pink Eye Conjunctivitis Eye Infection Eye Discharge

null

2

arm 1: None arm 2: None

[ 0, 3 ]

2

[ 0, 10 ]

intervention 1: 1.0% AzaSite contains 1.0% azithromycin, sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. AzaSite was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days. intervention 2: Vehicle contains sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. Vehicle was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.

intervention 1: AzaSite intervention 2: Vehicle

32

0

NCT00105534

[ 3 ]

122

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This drug is being developed to treat cardiac edema. The primary purpose of this study is to investigate the dose response for body weight in seven-day repeated oral administration of OPC-41061 at 15, 30, and 45 mg or placebo in patients with extracellular volume expansion secondary to CHF despite taking furosemide at 40 mg/d or more. This study is being conducted in Japan.

null

Heart Failure, Congestive Edema

OPC-41061 Tolvaptan Heart Failure Edema Extracellular volume expansion

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: OPC-41061(Tolvaptan)

1

Tokyo | N/A | Japan | 139.69171 | 35.6895

0

NCT00234104

[ 4 ]

478

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This is a double-blind, randomized, multicenter, parallel-group, equivalence study involving about 462 clinically stable hemodialysis patients aged 18 years or above suffering from anemia and treated previously with a stable dose of ERYPO® intravenously.

The primary objective of this Phase III study is the evaluation of therapeutic equivalence of HX575 Hexal AG and a comparator of epoetin alfa, ERYPO® in the maintenance intravenous treatment of renal anemia. Efficacy, dosage and safety of HX575 Hexal AG in the long-term treatment were assessed.

Anemia

Treatment of anemia in hemodialysis patients

null

2

arm 1: Eligible patients were switched from the comparator ERYPO®, to epoetin alfa HX575 Hexal AG in ratio 2:1 to be intravenously treated with HX575 in pre-filled syringes for 24 weeks (solution for injection i.v.). The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. arm 2: Eligible patients were randomized and continued to be treated with ERYPO® Janssen-Cilag in pre-filled syringes intravenously (solution for injection i.v.) for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: HX575 Solution for i.v. injection Containing 1000, 2000 and 4000 IU of rh erythropoietin intervention 2: Solution for i.v. injection

intervention 1: HX575 epoetin alfa Hexal AG intervention 2: ERYPO®, Janssen-Cilag

54

Feldkirch | N/A | Austria | 9.6 | 47.23306 Graz | N/A | Austria | 15.45 | 47.06667 Graz | N/A | Austria | 15.45 | 47.06667 Graz | N/A | Austria | 15.45 | 47.06667 Innsbruck | N/A | Austria | 11.39454 | 47.26266 Sankt Pölten | N/A | Austria | 15.63333 | 48.2 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Aschaffenburg | N/A | Germany | 9.15214 | 49.97704 Bad Münder am Deister | N/A | Germany | 9.46421 | 52.19551 Bad Nauheim | N/A | Germany | 8.73859 | 50.36463 Bamberg | N/A | Germany | 10.90067 | 49.89873 Bayreuth | N/A | Germany | 11.57893 | 49.94782 Bergisch Gladbach | N/A | Germany | 7.13298 | 50.9856 Berlin | N/A | Germany | 13.41053 | 52.52437 Bischofswerda | N/A | Germany | 14.17974 | 51.12771 Bremerhaven | N/A | Germany | 8.57553 | 53.55357 Coburg | N/A | Germany | 10.96384 | 50.25937 Coesfeld | N/A | Germany | 7.16809 | 51.94349 Deggendorf | N/A | Germany | 12.96068 | 48.84085 Donaueschingen | N/A | Germany | 8.49707 | 47.95514 Eberswalde | N/A | Germany | 13.81951 | 52.83492 Erkelenz | N/A | Germany | 6.31531 | 51.07947 Essen | N/A | Germany | 7.01228 | 51.45657 Freiberg | N/A | Germany | 13.33881 | 50.91089 Freiburg im Breisgau | N/A | Germany | 7.85222 | 47.9959 Fürstenzell | N/A | Germany | 13.31749 | 48.52163 Greifswald | N/A | Germany | 13.40244 | 54.08905 Gummersbach | N/A | Germany | 7.56473 | 51.02608 Günzburg | N/A | Germany | 10.27695 | 48.45599 Hamelin | N/A | Germany | 9.35623 | 52.10397 Hanover | N/A | Germany | 9.73322 | 52.37052 Haßfurt | N/A | Germany | 10.5156 | 50.03521 Heinsberg | N/A | Germany | 6.0998 | 51.06358 Homberg (Efze) | N/A | Germany | 9.40261 | 51.02994 Ingolstadt | N/A | Germany | 11.42372 | 48.76508 Jena | N/A | Germany | 11.5899 | 50.92878 Kronach | N/A | Germany | 11.33308 | 50.23963 Leipzig | N/A | Germany | 12.37129 | 51.33962 Leipzig | N/A | Germany | 12.37129 | 51.33962 Lohr | N/A | Germany | 10.70551 | 50.14608 Lübeck | N/A | Germany | 10.68729 | 53.86893 Menden | N/A | Germany | 7.77825 | 51.44337 München | N/A | Germany | 13.31243 | 51.60698 Neuried | N/A | Germany | 11.46561 | 48.09322 Nördlingen | N/A | Germany | 10.48868 | 48.85122 Nuremberg | N/A | Germany | 11.07752 | 49.45421 Oberschleißheim | N/A | Germany | 11.56667 | 48.25 Plauen | N/A | Germany | 12.13782 | 50.4973 Potsdam | N/A | Germany | 13.06566 | 52.39886 Saarbrücken | N/A | Germany | 7.00982 | 49.23262 Straubing | N/A | Germany | 12.57385 | 48.88126 Sulzbach-Rosenberg | N/A | Germany | 11.74598 | 49.50126

0

NCT00666835

[ 2 ]

45

RANDOMIZED

PARALLEL

null

2DOUBLE

true

0ALL

false

This study is a multiple ascending dose study to Assess the Safety, Tolerability, and Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 Days (27 Doses).

This study is a multiple ascending dose study to Assess the Safety, Tolerability, and Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 Days (27 Doses). The study is a multiple rising dose (MRD) study of active drug vs. placebo.

Healthy

Pharmacokinetics

null

5

arm 1: placebo capsule arm 2: 50 mg PG 760564 active arm 3: 100 mg PG 760564 active arm 4: 200 mg PG 760564 active arm 5: 400 mg PG 760564 active

[ 2, 0, 0, 0, 0 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: oral capsule, 2x/day for 14 days intervention 2: oral capsule, 50 mg, 2x/day for 14 days intervention 3: oral capsule, 100mg, 2x/day for 14 days intervention 4: oral capsule, 200 mg, 2x/day for 14 days intervention 5: oral capsule, 400 mg, 2x/day for 14 days

intervention 1: Placebo intervention 2: PG-760564 intervention 3: PG-760564 intervention 4: PG-760564 intervention 5: PG-760564

1

Miami | Florida | United States | -80.19366 | 25.77427

0

NCT00791388

[ 2 ]

10

RANDOMIZED

CROSSOVER

null

0NONE

true

0ALL

false

Half the group will be given a high fat diet and the other half will fast. They will then be crossed over.

A food-effect study which will be conducted at any time during the MRD study period on one single cohort of subjects using 200 mg oral dose of PG 760564. Half the group will be given a high fat diet and the other half will fast. They will ten be crossed over.

Healthy

pharmacokinetics study

null

2

arm 1: 200 mg PG 760564, Subjects Fasted, single dose arm 2: 200 mg PG 760564, Subjects Fed high fat meal

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 200 mg capsule, single dose,fasted when dosed, duration is 4 days intervention 2: 200 mg capsule, single dose,high fat diet when dosed, duration is 4 days

intervention 1: PG-760564 intervention 2: PG-760564

1

Miami | Florida | United States | -80.19366 | 25.77427

0

NCT00791817

[ 2 ]

188

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

0ALL

null

This 5-part study will evaluate the safety, tolerability, and pharmacokinetics of two formulations of MK-0517 (with and without polysorbate 80) and aprepitant in healthy adults. Parts I to IV of this study will examine different doses of MK-0517 as well as two different formulations of MK-0517 (with and without polysorbate 80). Part V of the study will compare single doses of intravenous non-PS80 MK-0517 to oral 125-mg capsule of aprepitant. The primary hypothesis for Part V of the study is that a single intravenous dose of 100-mg or 115-mg MK-0517 is area under the plasma-time curve (AUC) equivalent to that of the 125-mg oral aprepitant capsule in young healthy participants.

null

Chemotherapy-Induced Nausea and Vomiting Postoperative Nausea and Vomiting

null

14

arm 1: 100 mg MK-0517 (nonpolysorbate 80 formulation \[non-PS80\]) or placebo → 150 mg MK-0517 (non- PS80) or placebo → 125 mg aprepitant arm 2: 100 mg MK-0517 (PS80 formulation \[PS80\]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant arm 3: 40 mg MK-0517 (non-PS80) or placebo → 40 mg aprepitant arm 4: 2 mg midazolam → 100 mg MK-0517 (PS80) + 2 mg midazolam arm 5: 125 mg aprepitant → 90 mg MK-0517 (PS80) arm 6: 40 mg MK-0517 (non-PS80) → 125 mg aprepitant arm 7: 40 mg MK-0517 (non-PS80) arm 8: 40 mg MK-0517 (non-PS80 formulation) arm 9: 125 mg aprepitant → 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80 formulation) arm 10: 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80) → 125 mg aprepitant arm 11: 115 mg MK-0517 (PS80) → 125 mg aprepitant → 100 mg MK-0517 (PS80) arm 12: 125 mg aprepitant → 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) arm 13: 100 mg MK-0517 (PS80) → 125 mg aprepitant → 115 mg MK-0517 (PS80) arm 14: 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) → 125 mg aprepitant

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

12

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

intervention 1: MK-0517 (PS80 formulation), 1 mg/mL, administered intravenous (IV) over 15 minutes intervention 2: MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes intervention 3: MK-0517 (Non-PS80 formulation), 1 mg/mL, administered IV over 15 minutes. Midazolam is co-administered as a single oral 2-mg dose of midazolam with MK-0517. intervention 4: MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes intervention 5: MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes intervention 6: MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds. intervention 7: MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds. intervention 8: MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds. intervention 9: Placebo matching MK-0517 intervention 10: Aprepitant, oral, tablet, single dose intervention 11: Aprepitant oral tablet, single dose intervention 12: Midazolam oral tablet, single dose

intervention 1: 90 mg MK-0517 (PS80) intervention 2: 100 mg MK-0517 (PS80) intervention 3: 100 MK-0517 (PS80) + 2 mg midazolam intervention 4: 115 mg MK-0517 (PS80) intervention 5: 150 mg MK-0517 (PS80) intervention 6: 40 mg MK-0517 (non-PS80) intervention 7: 100 mg MK-0517 (non-PS80) intervention 8: 150 mg MK-0517 (Non-PS80) intervention 9: Placebo intervention 10: 40 mg Aprepitant intervention 11: 125 mg Aprepitant intervention 12: 2 mg Midazolam

0

null

0

NCT00990821

[ 5 ]

11

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

This study will assess whether daclizumab impairs the ability of children receiving a kidney transplant to elicit a primary immune response. The anticipated time on study treatment is 1 day, and the target sample size is 82 individuals.

null

Kidney Transplantation

null

2

arm 1: Participants who were receiving a full course of 5 doses of daclizumab (1 milligram per kilogram \[mg/kg\]) with Day 1 vaccine administered immediately prior to the fifth dose. arm 2: Participants who completed a full course of daclizumab therapy in the previous 4 to 18 months.

[ 0, 1 ]

3

[ 2, 0, 2 ]

intervention 1: Diphtheria and Tetanus Toxoid (DT) will be administered intramuscularly as a 1/3 dilution (0.33 flocculation units). The participants will be rechallenged with DT 6 months after Day 29 if failed to show \>=1.5 fold increase in lymphocyte proliferative response but have a humoral response. intervention 2: The fifth dose (1 milligram per kilogram \[mg/kg\]) of daclizumab will be administered in this study to participants who already received four doses (one dose at 1 mg/kg within 24 hours post-transplant and then every other week for 3 doses). intervention 3: KLH will be administered intradermally with a dose of 250 mcg for participants aged 2 to less than 12 years, and 500 mcg for participants aged 12 to 19 years. The participants will be rechallenged with KLH 6 months after Day 29 if failed to show specified increase in lymphocyte proliferative response or humoral response.

intervention 1: DT intervention 2: Daclizumab intervention 3: KLH

5

0

NCT02576145

[ 3 ]

152

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

Study will assess efficacy, safety and tolerability of brivaracetam in post-herpetic neuralgia (PHN). Duration of 7 weeks divided into 3 periods with no up-titration, nor down-titration.

null

Neuralgia, Postherpetic

Post-herpetic Neuralgia (PHN) Brivaracetam

null

3

arm 1: Matching placebo tablets administered twice a day. arm 2: Brivaracetam 200 mg/day (100 mg administered twice a day). arm 3: Brivaracetam 400 mg/day (200 mg administered twice a day).

[ 2, 0, 0 ]

2

[ 0, 0 ]

intervention 1: Daily oral dose of two equal intakes. intervention 2: Daily oral dose of two equal intakes.

intervention 1: Placebo intervention 2: Brivaracetam

50

Brussels | N/A | Belgium | 4.34878 | 50.85045 Eeklo | N/A | Belgium | 3.55654 | 51.18703 Genk | N/A | Belgium | 5.50082 | 50.965 Liège | N/A | Belgium | 5.56749 | 50.63373 Lubbeek (Pellenberg) | N/A | Belgium | 4.83896 | 50.88278 Pleven | N/A | Bulgaria | 24.61667 | 43.41667 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Varna | N/A | Bulgaria | 27.91667 | 43.21667 Hradec Králové | N/A | Czechia | 15.83277 | 50.20923 Prague | N/A | Czechia | 14.42076 | 50.08804 Svitavy | N/A | Czechia | 16.46829 | 49.75594 Ústí nad Labem | N/A | Czechia | 14.03227 | 50.6607 Annecy | N/A | France | 6.12565 | 45.90878 Clermont-Ferrand | N/A | France | 3.08682 | 45.77969 Nice | N/A | France | 7.26608 | 43.70313 Toulouse | N/A | France | 1.44367 | 43.60426 Voiron | N/A | France | 5.5856 | 45.36471 Bad Wörishofen | N/A | Germany | 10.59666 | 48.00674 Bochum | N/A | Germany | 7.21648 | 51.48165 Essen | N/A | Germany | 7.01228 | 51.45657 Kassel | N/A | Germany | 9.5 | 51.31667 Rodgau | N/A | Germany | 8.88588 | 50.02627 Gdansk | N/A | Poland | 18.64912 | 54.35227 Grudziądz | N/A | Poland | 18.75366 | 53.48411 Katowice | N/A | Poland | 19.02754 | 50.25841 Kielce | N/A | Poland | 20.62752 | 50.87033 Krakow | N/A | Poland | 19.93658 | 50.06143 Lublin | N/A | Poland | 22.56667 | 51.25 Olsztyn | N/A | Poland | 20.49416 | 53.77995 Poznan | N/A | Poland | 16.92993 | 52.40692 Warsaw | N/A | Poland | 21.01178 | 52.22977 Wroclaw | N/A | Poland | 17.03333 | 51.1 Zgierz | N/A | Poland | 19.40623 | 51.85561 Belgarde | N/A | Serbia | N/A | N/A Belgrade | N/A | Serbia | 20.46513 | 44.80401 Kragujevac | N/A | Serbia | 20.91667 | 44.01667 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Dubnica nad Váhom | N/A | Slovakia | 18.16634 | 48.95981 Košice | N/A | Slovakia | 21.25808 | 48.71395 Nitra | N/A | Slovakia | 18.08453 | 48.30763 Cadiz | N/A | Spain | -6.2891 | 36.52672 Granada | N/A | Spain | -3.60667 | 37.18817 Hospitalet de Llobregat (Barcelona) | N/A | Spain | 2.10028 | 41.35967 Madrid | N/A | Spain | -3.70256 | 40.4165 Sant Cugat Del Valles (Barcelona) | N/A | Spain | 2.08611 | 41.47063 Valencia | N/A | Spain | -0.37966 | 39.47391 Bath | N/A | United Kingdom | -2.36172 | 51.3751 Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 London | N/A | United Kingdom | -0.12574 | 51.50853 Winchester | N/A | United Kingdom | -1.3187 | 51.06513

0

NCT00160667

[ 5 ]

73

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

true

0ALL

false

Eligible subjects will be randomized to receive VALTREX® tablet 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days between treatment periods.

null

Infections, Herpesviridae

viral shedding Recurrent herpes genital herpes

null

2

arm 1: VALTREX 1 g once daily, Placebo arm 2: Placebo, VALTREX 1 g once daily

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Valtrex 1g once daily intervention 2: placebo

intervention 1: Valaciclovir intervention 2: Placebo

17

0

NCT00116844

[ 4 ]

946

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

1FEMALE

false

To investigate efficacy and safety of 4 doses of esmirtazapine, compared to placebo, in the treatment of moderate to severe hot flushes (vasomotor symptoms) associated with the menopause. Co-primary efficacy endpoints are the frequency and severity of hot flushes after 4 and 12 weeks as compared to Baseline.

The most direct treatment of hot flushes may be by means of 5-HT2A receptor antagonist. Mirtazapine is a potent blocker of 5-HT2A receptors and was found to be effective in reducing the number and intensity of hot flushes in preliminary trials. Also several Selective Serotonin Reuptake Inhibitors (SSRIs) and other similar compounds have been investigated to manage hot flushes, confirming the role of the serotonergic system. In the present trial, the efficacy and safety of four different doses of esmirtazapine compared to placebo were investigated in women with moderate to severe vasomotor symptoms associated with the menopause. The primary objective of this trial was to demonstrate superior efficacy in at least one of the four doses of esmirtazapine as compared to placebo on the four following co-primary endpoints: 1) the mean change from baseline in average daily frequency of moderate and severe vasomotor symptoms at Week 4; 2) the mean change from baseline in average daily frequency of moderate and severe vasomotor symptoms at Week 12; 3) the mean change from baseline in average daily severity of moderate and severe vasomotor symptoms at Week 4; 4) the mean change from baseline in average daily severity of moderate and severe vasomotor symptoms at Week 12. The number and severity of hot flushes was recorded by means of electronic diary by the subjects.

Postmenopausal Symptoms Menopause Vasomotor Symptoms

null

5

arm 1: Participants receive encapsulated tablets, orally, once daily (QD) for up to 12 weeks. arm 2: Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks. arm 3: Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks. arm 4: Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks. arm 5: Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.

[ 2, 0, 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: Four different doses (2.25, 4.5, 9.0, and 18 mg) encapsulated esmirtazapine tablets in Swedish Orange hard gelatin DB-B capsules for blinding purposes. Encapsulated tablets were administered orally once daily in the evening prior to sleep for 12 weeks. intervention 2: Encapsulated placebo tablets in Swedish Orange hard gelatin DB-B capsules for blinding purposes. Encapsulated tablets were administered orally once daily in the evening prior to sleep for 12 weeks.

intervention 1: Esmirtazapine intervention 2: Placebo

0

null

0

NCT00535288

[ 4 ]

943

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

1FEMALE

false

The most direct treatment of vasomotor symptions (hot flushes) may be by means of 5-HT2A receptor antagonist. Mirtazapine is a potent blocker of 5-HT2A receptors and was found to be effective in reducing the number and intensity of hot flushes in preliminary trials. Also several Selective Serotonin Reuptake Inhibitors (SSRIs) and other similar compounds have been investigated to manage hot flushes, confirming the role of the serotonergic system. In the present trial, the efficacy and safety of four different doses of esmirtazapine compared to placebo was investigated in women with moderate to severe vasomotor symptoms associated with the menopause. The primary study hypothesis was that esmirtazapine would show superior efficacy to placebo.

null

Menopause Vasomotor Symptoms

null

5

arm 1: Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks arm 2: Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks arm 3: Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks arm 4: Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks arm 5: Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks

[ 2, 0, 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: esmirtazapine intervention 2: Placebo

0

null

0

NCT00560833

[ 5 ]

166

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

null

Clinical validation of the assisted reproductive technology (ART) treatment guidelines, which determine the optimal dose of recombinant human follicle stimulating hormone (r-hFSH) based on subject baseline characteristics/predictors of ovarian response.

null

Infertility

Assisted Reproductive Technology (ART) Infertility Ovarian stimulation

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, 0, 0, 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: GONAL-f (follitropin alfa) will be administered subcutaneously based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. intervention 2: When at least 1 follicle greater than or equal to (\>=) 18 millimeter (mm) and 2 follicles \>=16 mm in diameter develop, 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) will be administered.

intervention 1: Gonal-f intervention 2: Recombinant human chorionic gonadotrophin (r-hCG)

1

Paris | N/A | France | 2.3488 | 48.85341

0

NCT00249834

[ 4 ]

223

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Open-label study to allow pediatric patients who have participated in prior Levetiracetam (Keppra®) studies to continue their treatment with adequate monitoring and standardized follow-up care until Levetiracetam (Keppra®) is approved for use in children or until the completion of the development program for pediatrics.

null

Epilepsy, Partial

Epilepsy Pediatric Partial onset epilepsy Levetiracetam Keppra

null

4

arm 1: Subjects had previously participated in study N159 in which they had received Placebo (PBO). arm 2: Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV). arm 3: Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV). arm 4: Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).

[ 0, 0, 0, 0 ]

1

[ 0 ]

intervention 1: * Pharmaceutical form: Oral tablets and oral solution * Route of administration: Oral use

intervention 1: Levetiracetam

0

null

1

NCT00150709

[ 3 ]

104

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this study is to exploratively investigate the clinical efficacy of rebamipide on dry mouth in patients with Sjögren's syndrome in comparison with placebo.

null

Xerostomia Sjogren's Syndrome

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: Rebamipide

1

Tokyo | N/A | Japan | 139.69171 | 35.6895

0

NCT00233363

[ 5 ]

81

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

This study will use a randomized, double-blind, controlled trial design in order to assess the safety and efficacy of levalbuterol (LEV) compared to racemic albuterol (RAC) when delivered continuously in a high-dose regimen for children with severe exacerbations of asthma. Primary hypothesis * Children with severe asthma receiving continuous levalbuterol will have a shorter duration of continuous therapy as compared to racemic albuterol. Secondary hypotheses * Children receiving continuous levalbuterol will have improved lung function measured by forced expiratory volume at 1 second (FEV1) as compared to racemic albuterol. * Children receiving continuous levalbuterol will have improved clinical asthma score as compared to racemic albuterol.

High-dose nebulized albuterol is standard therapy for severe asthma exacerbations at The Children's Hospital of Philadelphia (CHOP) and other tertiary care pediatric hospitals throughout the United States. For the most severe exacerbations, albuterol is provided continuously at high doses until improvement is observed. This regimen has been standardized in a treatment protocol that has been used at CHOP for more than 5 years. Recently, levalbuterol (LEV), the purified active (R)-enantiomer of albuterol, has been approved for use in acute asthma. Preliminary evidence suggests that LEV may improve pulmonary function and clinical outcomes in children with asthma based on studies using standard dosing regimens. Laboratory and clinical evidence suggest that the (S)-enantiomer of albuterol may have detrimental effects that contribute to poor response to racemic albuterol (RAC). Limited data exist about the efficacy of LEV in high-dose regimens. This study will use a randomized, double-blind, controlled trial design in order to assess the safety and efficacy of LEV compared to RAC when delivered continuously in a high-dose regimen for severe exacerbations of asthma. Children treated for asthma exacerbations in the CHOP emergency department (ED) will be eligible for study enrollment. Those that meet enrollment criteria will be randomized to receive either high dose RAC according to the standard asthma care protocol or equivalent dosing of LEV. Approximately 128 patients with 64 in each arm of the study will be enrolled. An interim safety analysis will be conducted after the first 40 patients are enrolled. This study should be completed in six to nine months. The primary outcome will be duration of continuous therapy. Secondary outcomes will include improvement of clinical asthma score and change in forced expiratory volume in one second (FEV1). In addition, (R)-albuterol and (S)-albuterol levels will be measured at study entry and at 6-hour intervals in the first 40 patients enrolled. These values will be used to determine prior RAC exposure and to determine serum levels of (R) and (S) albuterol during continuous therapy.

Asthma

Asthma Levalbuterol Albuterol Children

null

2

arm 1: Nebulized levalbuterol 10mg/hr given continuously arm 2: Racemic albuterol 20mg/hr given continuously

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 20mg/hr continuous racemic albuterol intervention 2: 10mg/hr continuous nebulized levalbuterol

intervention 1: Racemic albuterol (R+S albuterol) intervention 2: Levalbuterol (R albuterol)

1

Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238

0

NCT00124176

[ 3 ]

172

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

Multicenter, randomized, double-blind, placebo-controlled, 5-arm, dose-ranging study to assess the efficacy of subcutaneous injections of Golimumab (CNTO 148), 50 or 100 mg, at either 2- or 4- week intervals in subjects with active RA despite MTX therapy.

This is an experimental medical research study. The purpose of this study is to determine if Golimumab is safe and effective in the treatment of rheumatoid arthritis. Subjects will receive subcutaneous injections of either 50 or 100 mg Golimumab or placebo every two or four weeks or an infusion of infliximab at week 20, 22, 28, 36, 44 for 48 weeks

Rheumatoid Arthritis

Rheumatoid Arthritis CNTO 148 Methotrexate Joint pain Arthritis

null

3

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

[ 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Type=exact, unit=mg/ml, number= 50 to 100 , form=powder for solution for infusion, route=sub cutaneous. intervention 2: Type=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneous intervention 3: Type=exact, unit=mg/ml, form=powder for solution for infusion, route=sub cutaneous intervention 4: Type=exact, unit=mg/ml number= 10, form=powder for solution for infusion, route=sub cutaneous

intervention 1: Golimumab intervention 2: MTX intervention 3: Placebo intervention 4: Infliximab

0

null

0

NCT00207714

[ 3 ]

124

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

Lung wash with KL₄Surfactant of individual lung segments using a bronchoscope compared to usual care alone consisting primarily of assisted (mechanical) ventilation in patients with acute respiratory distress syndrome(ARDS).

This is a multinational, multicenter, two-part, Phase 2 study that will evaluate the tolerability, safety, and efficacy of KL₄Surfactant in adult ARDS patients when administered by sequential bronchoscopic lavage into each of the 19 bronchopulmonary segments of the lung and as a bolus instillation into each lung.

Acute Respiratory Distress Syndrome

null

7

arm 1: 3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours. arm 2: 3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours. arm 3: 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. arm 4: 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later. arm 5: 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. arm 6: 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later. arm 7: Received standard ARDS management and ICU care (Standard of Care \[SOC\]). Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.

[ 0, 0, 0, 0, 0, 0, 5 ]

7

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

intervention 1: 3 30 mL aliquots at concentrations of 5, 5, and 10 mg/mL intervention 2: Standard ARDS management and ICU care intervention 3: 3 30 mL aliquots at a concentration of 10 mg/mL each intervention 4: 2 50 mL aliquots at concentrations of 10 and 20 mg/mL intervention 5: 2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed intervention 6: 2 50 mL aliquots at concentrations of 10 and 20 mg/mL intervention 7: 2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed

intervention 1: A.1 Lucinactant intervention 2: B.3 SoC intervention 3: A.2 Lucinactant intervention 4: A.3 Lucinactant intervention 5: A.4 Lucinactant intervention 6: B.1 Lucinactant intervention 7: B.2 Lucinactant

1

Warrington | Pennsylvania | United States | -75.13406 | 40.24927

0

NCT00215553

[ 4 ]

39

RANDOMIZED

CROSSOVER

0TREATMENT

1SINGLE

false

0ALL

false

This is a Phase 3, single-dose, investigator-blind, randomized, placebo-controlled, crossover study, conducted at a single site in Austria, outside of the normal grass pollen season. An allergic reaction will be induced by exposing subjects to grass pollen in the Vienna Challenge Chamber (VCC). Subjects will receive a single dose of each of the following treatments according to a randomization sequence: Phenylephrine 12 mg immediate-release capsule, pseudoephedrine 60 mg immediate-release tablet, and placebo capsule. There will be a minimum of a 5-day washout period between each treatment. Subjects will complete symptom evaluations throughout the study. The nasal decongestant effects of phenylephrine will be compared to those of placebo using the subjective symptom evaluations. The safety profile (adverse events and vital signs) of the treatments will also be evaluated.

null

Rhinitis, Allergic, Seasonal

null

6

arm 1: Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. arm 2: Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. arm 3: Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. arm 4: Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. arm 5: Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. arm 6: Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration.

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

3

[ 0, 0, 0 ]

intervention 1: immediate-release 12 mg capsules for oral administration intervention 2: 60 mg immediate-release tablets for oral administration intervention 3: placebo capsules

intervention 1: phenylephrine intervention 2: pseudoephedrine intervention 3: placebo

0

null

0

NCT00276016

[ 4 ]

361

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

false

This study compares the safety and efficacy of intravenous iron vs oral iron in subjects who display postpartum anemia.

This is an open label, Phase III, randomized, active controlled study of intravenous iron vs oral iron in anemic post partum patients.

Anemia

Anemia postpartum Postpartum anemia

null

2

arm 1: A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered arm 2: 325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42 intervention 2: A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered

intervention 1: Oral iron tablets intervention 2: VIT-45

1

Norristown | Pennsylvania | United States | -75.3399 | 40.1215

0

NCT00396292

[ 3 ]

45

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Wegener's granulomatosis is a primary systemic vasculitis characterized by granulomatous and necrotizing inflammation predominantly affecting the respiratory tract and the kidneys. Conventional therapy of Wegener's granulomatosis with cyclophosphamide and corticosteroids is limited by incomplete remissions and a high relapse rate. Patients accumulate irreversible damage due to the disease and the consequences of prolonged drug exposure. The efficacy and safety of an alternative immunosuppressive drug, gusperimus, was evaluated in patients with refractory disease. A prospective, international, nulti-centre, single limb, open label study. Entry required active Wegener's granulomatosis with a Birmingham Vasculitis Activity Score (BVAS) \>=4 and previous therapy with cyclophosphamide or methotrexate. Immunosuppressive drugs were withdrawn at entry and prednisolone doses adjusted according to clinical status. Gusperimus, 0.5mg/kg/day, was self-administered by subcutaneous injection in six treatment cycles of 21 days with a seven day washout between cycles. Cycles were stopped early for white blood count \< 4,000/mm3. The primary endpoint was complete remission (BVAS=0 for at least 2 months) or partial remission (BVAS\<50% of entry score). After the sixth cycle azathioprine was commenced and follow-up continued for a further six months.

null

Wegener's Granulomatosis

Wegener Granulomatosis Vasculitis Gusperimus Immunosuppression

null

1

arm 1: Gusperimus

[ 0 ]

1

[ 0 ]

intervention 1: SC, 0.5mg/kg/day, consecutive 21 days administration, 1 to 2 weeks rest, 6 cycles

intervention 1: Gusperimus

7

Prague | N/A | Czechia | 14.42076 | 50.08804 Copenhagen | N/A | Denmark | 12.56553 | 55.67594 Lübeck | N/A | Germany | 10.68729 | 53.86893 Maastricht | N/A | Netherlands | 5.68889 | 50.84833 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Edinburgh | Scotland | United Kingdom | -3.19648 | 55.95206 Cambridge | N/A | United Kingdom | 0.11667 | 52.2

0

NCT00530075

[ 0 ]

144

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

false

A prospective study to evaluate the efficacy of classic homeopathic therapy compared to maintenance itraconazole therapy with and without additional exogenous lactobacillus for treatment of recurrent Candida vaginitis.

Objective: Antimycotics effectively treat sporadic and recurrent vulvovaginal candidiasis (RVVC). Classic homeopathy (CH) is also used to treat this condition. We compared the efficacy of CH and itraconazole in reducing the frequency of RVVC episodes. Design: Single-centre, prospective, randomized. Sample: One-hundred-and-fifty patients with a history of RVVC and an acute episode of VVC. Methods: Women were randomised into 3 groups: itraconazole with lactobacilli (group 1), itraconazole without lactobacilli (group 2) and CH (group 3). Itraconazole treatment of acute infection was followed by a 6-months maintenance regimen with monthly single-day itraconazole (200 mg bid). Thereafter, patients were followed without treatment for 6 months. Women in group 1 were given additional vaginal lactobacilli for six days per month. CH treatment was performed for 12 months.

Vulvovaginal Candidiasis

recurrent vulvovaginal candidiasis itraconazole classic homeopathy

null

3

arm 1: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). arm 2: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). Additionally, Lactobacillus vaginal tablets monthly given through 6 days. arm 3: CH treatment was provided by a licensed CH practitioner. Specifically, a personal history was taken and an individualised treatment scheme was prescribed. The most often used homeopathic remedies were carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, and sepia M. Potencies of homeopathic remedies ranged from C 30 to C 1000.

[ 1, 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid) intervention 2: Lactobacillus vaginal tablets monthly given through 6 days intervention 3: CH treatment was provided by a licensed CH practitioner. Specifically, a personal history was taken and an individualised treatment scheme was prescribed. The most often used homeopathic remedies were carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, and sepia M. Potencies of homeopathic remedies ranged from C 30 to C 1000.

intervention 1: itraconazole intervention 2: lactobacillus gasseri intervention 3: classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed)

1

Vienna | N/A | Austria | 16.37208 | 48.20849

0

NCT00895453

[ 2 ]

17

null

PARALLEL

0TREATMENT

0NONE

true

0ALL

false

Open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls. The trial consisted of a screening visit, a treatment phase and a follow-up visit. All subjects were to be treated with study medication for 8 consecutive days. Blood and urine were collected for the PK analysis, and safety assessments were performed.

The screening visit was performed 2 to 21 days before the first administration of study medication, the treatment phase consisted of 12 days (of which study medication was administered during the first 8 days), and the follow-up visit was performed 15 to 19 days after the first administration of study medication.

Epilepsy

null

2

arm 1: This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls arm 2: This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls

[ 5, 5 ]

1

[ 0 ]

intervention 1: None

intervention 1: BIA 2-093

1

Bloemfontein | Bloemfontein | South Africa | 26.214 | -29.12107

0

NCT02281526

[ 4 ]

352

RANDOMIZED

PARALLEL

0TREATMENT

null

false

0ALL

null

The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (VMR).

null

Rhinitis, Vasomotor

Vasomotor Rhinitis VMR nonallergic rhinitis GW685698X

null

1

arm 1: GW685698X

[ 0 ]

1

[ 0 ]

intervention 1: Aqueous Nasal Spray 100mcg

intervention 1: GW685698X

53

0

NCT00117325

[ 4 ]

350

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (VMR).

null

Vasomotor Rhinitis Rhinitis, Vasomotor

nonallergic rhinitis GW685698X VMR vasomotor rhinitis

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: GW685698X

59

0

NCT00118703

[ 4 ]

506

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to determine if Sarizotan HC1 1 mg b.i.d. (taken twice a day) is effective in the treatment of dyskinesia associated with dopaminergic treatment of Parkinson's disease (PD).

null

Parkinson's Disease Dyskinesia

Parkinson's Disease Dyskinesia Dyskinesia associated with dopaminergic treatment

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Subjects will receive sarizotan 1 milligram orally twice daily for 24 weeks. intervention 2: Subjects will receive placebo matched to sarizotan orally twice daily for 24 weeks.

intervention 1: Sarizotan intervention 2: Placebo

31

0

NCT00105508

[ 5 ]

1,469

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study will evaluate the efficacy and safety of different durations of treatment with PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never previously received interferon (IFN) therapy. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.

null

Hepatitis C, Chronic

null

2

arm 1: None arm 2: None

[ 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 400mg po bid for 16 weeks intervention 2: 400mg po bid for 24 weeks intervention 3: 180 micrograms sc weekly for 16 weeks intervention 4: 180 micrograms sc weekly for 24 weeks

intervention 1: Copegus intervention 2: Copegus intervention 3: peginterferon alfa-2a [Pegasys] intervention 4: peginterferon alfa-2a [Pegasys]

132

1

NCT00077636

[ 4 ]

24

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

This study will evaluate the benefit of adding sertraline (Zoloft®) to Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for sexually abused children who have Posttraumatic Stress Disorder (PTSD).

Adult research has demonstrated the efficacy of selective serotonin reuptake inhibitors (SSRIs) in decreasing Posttraumatic Stress Disorder (PTSD) symptoms; to date the SSRIs are the only medication class with demonstrated efficacy in treating all three PTSD symptom clusters (reexperiencing, avoidance, and hyperarousal). No studies have evaluated the impact of SSRIs on PTSD symptoms in children or adolescents. Trauma-focused CBT has been shown in several studies to be efficacious in decreasing PTSD symptoms in sexually abused children and adolescents. Many children and youth with PTSD are currently prescribed SSRIs and other medications. This study will evaluate whether adding the SSRI sertraline provides additional benefits over TF-CBT treatment for sexually abused children and adolescents with PTSD. If adequate numbers of children with comorbid PTSD and depressive and/or anxiety disorders are included, it may also be possible to evaluate whether any benefit of adding sertraline is restricted to those children with comorbid disorders.

Stress Disorders, Post-Traumatic

PTSD Depression Anxiety

null

2

arm 1: Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day arm 2: Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)

[ 0, 1 ]

3

[ 5, 0, 0 ]

intervention 1: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent intervention 2: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT intervention 3: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT

intervention 1: Trauma-Focused Cognitive Behavioral Therapy intervention 2: Sertraline Pill intervention 3: Placebo Oral Tablet

1

Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062

0

NCT00078767

[ 5 ]

57

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This study will evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the target sample size is \>100 individuals.

null

Hepatitis C, Chronic

null

2

arm 1: Participants will receive Pegasys 180 micro grams (µg or mcg) subcutaneously (SC) once a week and ribavirin 1000 or 1200 milligrams per day \[(mg/day), \< or \>=75 kilogram (Kg) body weight, respectively\], orally in divided doses for 60 weeks. arm 2: Participants will receive Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (\< or \>=75 kg body weight, respectively) orally in divided doses for 36 weeks.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 1000/1200mg po bid for 36 or 60 weeks intervention 2: 180 micrograms weekly for 36 weeks (non-responders) or 60 weeks (non-tolerators)

intervention 1: Ribavirin intervention 2: peginterferon alfa-2a [Pegasys]

25

0

NCT00087568

[ 4 ]

207

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

Prolongation of the EPAAC™ trial - NCT00152464 (The Early Prevention of Asthma in Atopic Children). 36 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in young atopic children.

null

Asthma

Pediatry EPAAC atopic Children prevention of asthma Levocetirizine Xyzal

null

3

arm 1: Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ-LCTZ) arm 2: Placebo after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ - PLC) arm 3: Placebo after having been randomized to Placebo in the preceding A00309 trial - NCT00152464 (PLC-PLC)

[ 0, 2, 2 ]

2

[ 0, 10 ]

intervention 1: 5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months intervention 2: Oral drops, bid for 18 months

intervention 1: LEVOCETIRIZINE intervention 2: Placebo

51

North Adelaide | N/A | Australia | 138.59141 | -34.90733 Parkville (North Melbourne) | N/A | Australia | 144.95 | -37.78333 Brussels | N/A | Belgium | 4.34878 | 50.85045 Brno | N/A | Czechia | 16.60796 | 49.19522 Hradec Králové | N/A | Czechia | 15.83277 | 50.20923 Olomouc | N/A | Czechia | 17.25175 | 49.59552 Ostrava | N/A | Czechia | 18.28204 | 49.83465 Plezen-Lochotin | N/A | Czechia | N/A | N/A Prague | N/A | Czechia | 14.42076 | 50.08804 Martigues | N/A | France | 5.05526 | 43.40735 Saint-Etienne | N/A | France | 4.39 | 45.43389 Tarbes | N/A | France | 0.07139 | 43.23407 Toulouse | N/A | France | 1.44367 | 43.60426 Bayreuth | N/A | Germany | 11.57893 | 49.94782 Berlin | N/A | Germany | 13.41053 | 52.52437 Bielefeld | N/A | Germany | 8.53333 | 52.03333 Bochum | N/A | Germany | 7.21648 | 51.48165 Cologne | N/A | Germany | 6.95 | 50.93333 Erlangen | N/A | Germany | 11.00783 | 49.59099 München | N/A | Germany | 13.31243 | 51.60698 Wesel | N/A | Germany | 6.62037 | 51.6669 Ancona | N/A | Italy | 13.5103 | 43.60717 Bari | N/A | Italy | 16.86982 | 41.12066 Bologna | N/A | Italy | 11.33875 | 44.49381 Messina | N/A | Italy | 15.55256 | 38.19394 Milan | N/A | Italy | 12.59836 | 42.78235 Napoli | N/A | Italy | 14.5195 | 40.87618 Pavia | N/A | Italy | 9.15917 | 45.19205 Roma | N/A | Italy | 11.10642 | 44.99364 Bialystock | N/A | Poland | N/A | N/A Gdansk | N/A | Poland | 18.64912 | 54.35227 Karpacz | N/A | Poland | 15.75594 | 50.77669 Lodz | N/A | Poland | 19.47395 | 51.77058 Lublin | N/A | Poland | 22.56667 | 51.25 Rabka-Zdrój | N/A | Poland | 19.96654 | 49.60889 Warsaw | N/A | Poland | 21.01178 | 52.22977 Wroclaw | N/A | Poland | 17.03333 | 51.1 Bellville | N/A | South Africa | 18.62847 | -33.90022 Clarement | N/A | South Africa | N/A | N/A Durban | N/A | South Africa | 31.0292 | -29.8579 Mowbray | N/A | South Africa | 18.47333 | -33.94802 Pietermaritzburg | N/A | South Africa | 30.39278 | -29.61679 Sydenham | N/A | South Africa | 25.60223 | -33.92526 West Honeydew | N/A | South Africa | N/A | N/A Westville | N/A | South Africa | 30.937 | -29.82554 Wynberg | N/A | South Africa | 28.08466 | -26.11075 Barcelona | N/A | Spain | 2.15899 | 41.38879 Espluques de Llobreqat | N/A | Spain | N/A | N/A Dorchester | N/A | United Kingdom | -2.43333 | 50.71667 Enfield | N/A | United Kingdom | -0.08497 | 51.65147 Southampton | N/A | United Kingdom | -1.40428 | 50.90395

0

NCT00160563

[ 5 ]

23

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

true

1FEMALE

false

The purpose of this study is to compare post-operative pain after anesthesia with either isoflurane or propofol. Each group will be further randomized to receive intranasal nicotine or placebo in order to detect potential pronociceptive action of isoflurane. The study is a randomized, prospective, double-blinded controlled trial. Eighty adult women undergoing uterine surgery will be recruited for this study. Enrollment in this study is limited to women, because the animal studies suggest that females have a greater hyperalgesic response to volatile anesthetics than do males. The patient will be given one of two standard anesthetics for their surgery: isoflurane or propofol. The investigators are interested in these two anesthetics because we seek to see if there exists a difference in their effects on a patient's perception of pain, as has been shown to be the case in animal studies but has not yet been studied in humans.

A. Study Proposal and Rational The purpose of this study is to determine whether intranasal nicotine can decrease the negative side effects of the general anesthetic isoflurane. Isoflurane and other volatile anesthetics are potent antagonists of central nicotinic receptors. Nicotinic receptors are inhibited by isoflurane at the low concentrations that are present on emergence from anesthesia. Evidence from animal experiments suggests that inhibition of nicotinic receptors may cause increased sensitivity to pain and amnesia that occurs at low anesthetic concentrations. These anesthetic concentrations are frequently present on emergence from anesthesia. In these experiments, treatment with nicotine prevented the hyperalgesic state caused by isoflurane. Intranasal nicotine treatment has been used in smokers as an aid to smoking cessation. As nicotine acts as an agonist at sympathetic ganglia, it can cause increases in heart rate and blood pressure. At the dose to be used in this protocol (3mg intranasally) there was an average increase of 7 mM of mercury in systolic blood pressure and no change in diastolic blood pressure or heart rate in nonsmoking volunteers. B. Study Design and Statistical Analysis The study is a randomized prospective controlled trial. Women scheduled to undergo total abdominal hysterectomy or myomectomy will be randomly allocated intranasal nicotine or intranasal saline before emergence from a standard general anesthetic. The patient will be randomized to one of two standard anesthetics regimens that are described below. Both patient and investigator will be blinded to treatment. Nicotine or saline will be placed in a single use nasal spray bottle by the research pharmacy and identified by number. Randomization will be accomplished with a random number table. Patients will be enrolled sequentially. The study wishes to detect a 50% change in pain sensitivity and in our other studies, Visual Analog Pain Scale (VAS) scores and patient-controlled analgesia (PCA) utilization varied by approximately 40% (pooled variance). In order to achieve 80% power and p\<0.05, 40 women per group will be enrolled (total of 80 women). This study will include only female patients as animal studies suggest that females have a greater hyperalgesic response to isoflurane than males. Patients treated with nicotine will be compared to those treated with placebo for VAS score, PCA utilization and memory at 1 and 24 hours. C. Study Procedure The study subjects will be given one of two standardized anesthetics by an anesthesiologist at New York Presbyterian Hospital (NYPH) not involved with the study. The anesthesiologist will be familiarized with the study protocol prior to the surgery. The anesthetic protocols chosen are typical for this type of surgery, but is standardized to decrease variability in postoperative condition. After placing an intravenous catheter and standard anesthetic monitors, the patient will be pre oxygenated. Fentanyl will be administered at 12 micrograms/kg and a continuous infusion of 12 micrograms/kg/hr will be begun. Vecuronium 1 mg will be used to reduce fasciculation from succinylcholine. Anesthesia will be induced with propofol 2 mg/kg and intubation facilitated with succinylcholine 12 mg/kg. Anesthesia will be maintained with either isoflurane or propofol titrated by the anesthesiologist. All patients will be have a BIS monitor (a measure of processed EEG) titrated between 45-60 to assure adequacy and equivalence of anesthesia. Hypotension will be treated with ephedrine or phenylephrine as deemed necessary by the anesthesiologist. Hypertension will be treated with hydralazine or labatelol in doses determined by the anesthesiologist. If other hemodynamic or anesthetic drugs are deemed necessary by the anesthesiologist, the patient will be removed from the protocol. After closure of the abdominal fascia (typically, approximately 5 minutes before anticipated completion of the surgery) the general anesthetic and fentanyl drip will be titrated to off. Muscle relaxant will be reversed with neostigmine 0.1 mg/kg and glycopyrolate 0.01 mg/kg. At this time the study drug (nicotine 3 mg or saline) will be administered intranasally 3 mg (half to each nostril). The patient will be extubated by the anesthesiologist when she meets normal criteria (as determined by the anesthesiologist). Five minutes after extubation, the patient will be asked for a VAS score by the study coordinator. Pain will be treated with fentanyl by the anesthesiologist, 1 mg/kg every 5 minutes until VAS score is less than 3. PCA will then be begun with morphine 1 mg with a lockout of 6 minutes and a maximal 1 hour dose of 10 mg. A rescue dose of 3 mg morphine will be available to be administered by the nurse through the PCA every 5 minutes for a maximum of 12 mg in 4 hours. If pain is inadequately treated there will be an option to increase the patient demand dose to 1.5 mg morphine and the 1 hour maximum to 15 mg. This is a typical PCA protocol for this surgery. Post-anesthesia care unit (PACU) monitoring will be standard except that the patient's pain intensity will be monitored every 5 minutes in the first hour, once at the second hour and once at the twenty four hour period postoperatively by the study coordinator who will ask for a VAS score. PCA utilization will be determined from the amount of narcotic used from the PCA machine. The study will last during the patient's first postoperative day. D. Study Drugs Nicotine has been used commonly on an outpatient basis for smoking cessation. The investigators have chosen the intranasal route because of the kinetics of its action. Intranasal nicotine has its peak effect in five minutes and is dissipated in about 1 hour. In human studies, the hyperalgesic effect after a volatile anesthetic lasted about 1 hour. As nicotine acts as an agonist at sympathetic ganglia, it can cause increases in heart rate and blood pressure. At the dose to be used in this protocol (3mg intranasally) there was an average increase of 7 mM of mercury in systolic blood pressure and no change in diastolic blood pressure or heart rate in nonsmoking volunteers. The preliminary data do not show any significant increase in blood pressure or heart rate in patients who received nicotine. The investigators have chosen to study a dose of 3 mg because that dose had minimal hemodynamic effects and resulted in an arterial peak concentration of 100 microM and a steady state venous concentration of 30 microM nicotine. As nicotine crosses the blood brain barrier, these concentrations would be expected to result in significant activation of nicotinic receptors in the brain and spinal cord.

Postoperative Pain

Postoperative pain

null

2

arm 1: Propofol anesthetic with and without nicotine arm 2: isoflurane anesthetic with and without nicotine

[ 0, 0 ]

1

[ 0 ]

intervention 1: nicotine nasal spray (3mg) before surgery

intervention 1: Nicotine (drug)

1

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

0

NCT00232817

[ 3, 4 ]

70

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This study investigates whether sirolimus could decrease the rate of hepatoma recurrence after liver transplantation in high risk hepatoma patients.

A total of 70 patients with HCC (mean age: 54.6 years, female/male: 12/58) received a liver transplant and were included in the study. Immunosuppression included de novo sirolimus, low-dose calcineurin inhibitor for 6 to 12 months, with short-course (3 months) or no steroids.

Liver Carcinoma

liver transplant hepatocellular carcinoma sirolimus

null

1

arm 1: Sirolimus given intravenously or orally to achieve serum level of 12-20ug/l

[ 0 ]

1

[ 0 ]

intervention 1: Sirolimus given intravenously or orally to achieve target levels of 12-20ug/l

intervention 1: Sirolimus

1

Edmonton | Alberta | Canada | -113.46871 | 53.55014

0

NCT00328770

[ 3 ]

80

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

Chronic foot ulcers occurring among diabetic patients are difficult to heal. The frequent elderly age with co-morbidities, vascular insufficiencies, peripheral neuropathies and super imposed infections, all contribute towards the chronicity and failure of treatment. Preserving the ulcerated limb is the patients' wish. On the other hand, an infected ulcer that never heals just unnecessarily prolongs suffering. Nevertheless, patients earnestly like to try all methods of healing before accepting amputation. Objective:To determine whether a course of herbal preparation used as an adjuvant therapy for diabetic patients suffering from chronic foot ulcers may promote healing so that major leg amputation can be avoided.

null

Diabetic Foot Ulcer Amputation

Diabetic Foot Ulcer Traditional Chinese Medicine

null

2

arm 1: 12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day. arm 2: Placebo was made with starch and colouring materials. Given to patient orally twice a day

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: The Decoction is taken orally, twice a day, treatment period is 24 weeks The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients. The formula consisted of 12 herbs, viz: Radix astragali, Rhizoma atractylodis marcocephalae, Radix stephaniae tetrandrae, Radix polygoni multiflori, Radix rehmanniae, Radix smilax china, Fructus corni, Rhizoma dioscoreae, Cortex moutan, Rhizoma alismatis, Rhizoma smilacis glabrae, and Fructus schisandrae intervention 2: Placebo taking orally, twice a day, 24 week treatment period The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients. The placebo was made with starch and colouring materials.

intervention 1: TCM intervention 2: Placebo

2

Hong Kong | N/A | China | 114.17469 | 22.27832 Hong Kong | N/A | China | 114.17469 | 22.27832

0

NCT00393510

[ 4 ]

66

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to investigate the efficacy and safety of Cycloset® and placebo when added to metformin monotherapy (at least 1000 mg/day for 3 months prior to screening) in persons with type 2 diabetes mellitus who are not adequately controlled on metformin therapy alone.

In the previously conducted Phase III clinical trials, Cycloset® (up to a maximum dose of 4.8 mg/day), administered either as monotherapy or combined with sulfonylurea therapy, significantly reduced HbA1c, fasting and post-prandial glucose and fasting and post-prandial triglycerides in obese individuals with type 2 diabetes mellitus. Clinical studies that combined Cycloset® with metformin were not as part of the original Cycloset® clinical program because metformin was not commercially available in the United States at the time that the studies were initiated. The present study is designed to investigate the efficacy and safety of Cycloset® compared to placebo when added to metformin monotherapy in persons with type 2 diabetes mellitus who are not adequately controlled on metformin therapy alone. A sufficient number of individuals will be screened to enroll up to 326 subjects;approximately 276 subjects are expected to complete treatment through study termination (Week 26). The study population will consist of individuals currently treated with metformin, for at least 3 months prior to the study start. Subjects who have ever received exogenous insulin therapy as part of an outpatient diabetes treatment regimen are to be excluded, as are those taking oral anti-diabetic agents other than metformin within 3 months of screening (e.g., sulfonylureas, thiazolidinediones,alpha-glucosidase inhibitors, or meglitinides). Subjects may be male or female(surgically sterile, postmenopausal, or using appropriate contraceptive methods if of childbearing potential), age 18 to 75 years, inclusive, and are to have a screening HbA1c value of ≥ 7.5% and \<11.0% and a screening body mass index (BMI) in the range of 25 kg/m2 to 42 kg/m2, inclusive.

Type 2 Diabetes

diabetes diabetes mellitus

null

2

arm 1: Bromocriptine mesylate 0.8 mg arm 2: Bromocriptine mesylate 0.8 mg matching placebo

[ 1, 2 ]

1

[ 0 ]

intervention 1: 0.8 mg tablet

intervention 1: Bromocriptine Mesylate

0

null

0

NCT00441363

[ 2 ]

16

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

true

0ALL

false

This was a phase 1, double-blind, 4-way crossover study in healthy male and female volunteers. Subjects received 4 formulations of intranasal ketorolac tromethamine 30 mg. There was a wash-out period of 3-7 days between each dose. On Day 1 of each period subjects were randomised to receive either a single intranasal dose of 30 mg ketorolac tromethamine alone or single intranasal dose of 30 mg ketorolac tromethamine with 4%, 5% or 6% lidocaine hydrochloride. At the end of the study each subject had received all 4 treatments. The primary objective of this study in healthy volunteers was to compare the safety, tolerability, and pharmacokinetics of 4 formulations of ketorolac tromethamine. A secondary objective was to monitor lidocaine hydrochloride plasma levels.

null

Healthy Volunteers

null

4

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

[ 0, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 30 mg Ketorolac Tromethamine intranasal (IN) intervention 2: 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN intervention 3: 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN intervention 4: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN

intervention 1: Ketorolac Tromethamine intervention 2: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) intervention 3: Ketorolac Tromethamine with 5% Lidocaine HCl intervention 4: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl

1

Manchester | N/A | United Kingdom | -2.23743 | 53.48095

0

NCT01355588

[ 4 ]

215

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

null

This was a prospective, open-label, non-comparative, Phase IIIb trial to assess the convenience, safety and efficacy of the new Gonal-F fbm \[recombinant follicle stimulating hormone (r-FSH)\] liquid formulation, in common setting for ovulation induction (OI) and also in in-vitro fertilization (IVF).

null

Infertility Ovulation Induction In-Vitro Fertilization

Infertility Ovulation induction Gonal-F Follitropin alpha Controlled ovarian stimulation

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: GONAL-f® will be administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who undergo ovulation induction (OI)/artificial insemination (IUI) and between 150 and 225 IU per day for subjects who undergo in-vitro fertilization (IVF). For subjects who undergo OI/IUI, the dose will be increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response is observed.

intervention 1: GONAL-f®

1

Darmstadt | N/A | Germany | 8.65027 | 49.87167

0

NCT01183143

[ 4 ]

198

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study was to demonstrate in adult participants faster recovery from a neuromuscular block induced by either rocuronium or vecuronium after reversal at reappearance of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch, T1) by 2.0 mg/kg sugammadex (Org 25969) compared to 50 ug/kg neostigmine.

null

Anesthesia, General

null

4

arm 1: After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered arm 2: After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered arm 3: After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered arm 4: After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered

[ 0, 1, 0, 1 ]

2

[ 0, 0 ]

intervention 1: After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was to be administered intervention 2: After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered

intervention 1: Sugammadex intervention 2: Neostigmine

0

null

0

NCT00451217

[ 4 ]

514

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The Early Prevention of Asthma in Atopic Children (EPAAC™). 24 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in 12 to 24 months old children.

null

Dermatitis, Atopic

EPAAC Atopic children Asthma XYZAL Levocetirizine

null

2

arm 1: 0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily. arm 2: Placebo was administered as oral drops twice daily.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Pharmaceutical form: Oral drops Route of administration: Oral use intervention 2: Pharmaceutical form: Oral drops Concentration: 5 mg/ml Route of administration: Oral use

intervention 1: Placebo intervention 2: Levocetirizine

0

null

0

NCT00152464

[ 5 ]

385

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study will examine the viral kinetics and pharmacokinetics of Pegasys plus ribavirin and PEG-Intron plus ribavirin in interferon-naive patients with CHC. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

null

Hepatitis C, Chronic

null

2

arm 1: Participants received Peginterferon alfa-2a (40 kD) \[Pegasys\] at a dosage of 180 microgram (μg), subcutaneously (SC), once a week plus Ribavirin \[Copegus\] 1000 or 1200 milligram (mg)/day), orally, \[according to body weight, lesser than or greater than/equal to (\< or \>/=) 75 kilogram (kg), respectively\] twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (\< or \>/=75 kg body weight, respectively twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks. arm 2: Participants received Peginterferon alfa-2b (12 kD) \[PEG-Intron\] at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin \[Rebetol\] 1000 or 1200 mg/day orally (\< or \>/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (\< or \>/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.

[ 0, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 1000/1200mg/day po intervention 2: 1.5 micrograms/kg sc weekly intervention 3: 1000/1200mg/day po intervention 4: 180 micrograms sc weekly

intervention 1: Ribavirin intervention 2: Peginterferon alfa-2b (PEG-Intron) intervention 3: Ribavirin intervention 4: Peginterferon alfa-2a [Pegasys]

41

0

NCT00087607

[ 3 ]

58

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

false

Identifying new approaches for preventing breastmilk transmission of HIV-1 is an important research priority. To this end, clinical trials are underway to evaluate the efficacy of HAART (zidovudine, lamivudine, nevirapine) during late pregnancy/lactation versus zidovudine/nevirapine peripartum for prevention of breastmilk HIV-1 transmission. It is important to understand the mechanism of effect of these antiretroviral (ARV) strategies on prevention of breastmilk HIV-1 transmission. This phase II trial will compare HAART vs peripartum zidovudine/nevirapine for effect on breastmilk HIV-1, breastmilk HIV-1 specific immune responses, and infant HIV-1 specific immune responses. 100 pregnant HIV-1 seropositive women in Nairobi with CD4 counts between 200 to 500 who have chosen to breastfeed will receive either ARV regimen. Mother-infant pairs will be followed for 1 year after delivery. Home visits will be conducted in the first month (\~10 visits) to collect 2-5 mls of breastmilk per visit. Mother-infant pairs will be seen in the study clinic with maternal blood and breastmilk and infant blood collected at months 1, 3, and 6 for HIV-1 and HIV-1 Elispot assays. Breastmilk HIV-1 RNA and DNA levels will be quantified in Dr. Overbaugh's laboratory in Seattle and Elispot assays conducted in Nairobi with validation of a subset in Dr. Rowland-Jones laboratory in Oxford. Viral loads, decay curves, half-life, and re-population following ARV cessation will be estimated for each regimen and regimens compared. These studies will provide insight into the viral and immune responses to ARV regimens proposed for prevention of breastfeeding HIV-1 transmission and will be important for rational design of future interventions. After taking into account, estimated loss to follow-up, the targeted sample size with outcome data was 80 women, 40 in each trial arm, estimating undetectable breast milk HIV-1 RNA levels in the HAART arm and median breast milk HIV-1 RNA levels of 3.0 log10 in women receiving ZDV/NVP.

This will be a randomized study comparing breastfeeding women receiving zidovudine/nevirapine (from 36 weeks to delivery/first day postpartum) to women receiving HAART (zidovudine, nevirapine, lamivudine) initiated at 36 weeks and continuing throughout lactation (recommended for 6 months, breastfeeding cessation prior to HAART cessation). This a prospective cohort study that will follow HIV-1 seropositive women and their infants to be conducted in Nairobi. Women with CD4 counts between 200 and 500 will be randomized to one of the two regimens and compared. The study procedures are outlined below: 1. Voluntary HIV-1 counseling and testing in a Nairobi City council antenatal clinic: collection of blood using venipuncture following written informed consent. 2. Enrollment of HIV-1 infected women into new cohort before 32 wks gestation after written informed consent 3. Routine antenatal care including STD screening and multivitamins/iron 4. Collection of maternal blood and genital specimens at 32 weeks for STD diagnosis, HIV-1 RNA levels, CD4 counts, liver function tests, and complete blood counts. 5. Assignment to treatment depending on CD4 count at 34 weeks: 1. CD4\>500 zidovudine/nevirapine short-course treatment 2. CD4 200-500 randomization to zidovudine/nevirapine short-course or 3-drugs (nevirapine, zidovudine, and 3TC) during pregnancy and breastfeeding, with recommendation to stop breastfeeding at 6 months and the drugs to stop after cessation of breastfeeding 3. CD4\<200 3-drug regimen (nevirapine, zidovudine, and 3TC) through pregnancy and breastfeeding continued after cessation of breastfeeding with referral to sites in Nairobi providing long-term treatment 6. At delivery collection of maternal breastmilk (2-5 mls), cord blood (15 mls), maternal blood (15 mls), and infant blood (3 mls) for HIV-1 RNA, CD4 counts, HIV-1 specific CTL assays, complete blood counts, and liver function tests. 7. Collection of maternal breastmilk (2-5 mls) from home visits 3 times per week in the first 2 weeks, then 2 times per week for the next two weeks. Filter paper blood specimens will be collected weekly at the home visits. 8. Women receiving the 3-drug regimen who have expressible breastmilk after cessation of breastfeeding and cessation of drugs will also have home collection (3-5 mls) of specimens 3-times weekly for 2 weeks after cessation of breastfeeding. 9. Clinic visits at week 2, month 1, 3, and 6 with breastmilk and blood collection. Higher volumes of breastmilk (\~25 -50 mls) will be collected at the clinic visits (w2, m1, 3, and 6) for HIV-1 RNA, DNA and HIV-1 specific immune assays. Collection of maternal blood at week 2, month 1, 3, and 6 for HIV-1 RNA levels, CD4 counts, HIV-1 CTL levels, liver function tests, and complete blood counts. 10. Collection of infant blood at m1, 3, and 6 for HIV-1 and HIV-1 specific immune responses. Heel prick filter paper assays at months 9 and 12 for HIV-1 DNA PCR assays.

HIV Infections

breastmilk HIV-1 antiretroviral mother-to-child transmission

null

2

arm 1: Combined short-course Zidovudine/Nevirapine arm 2: HAART during pregnancy and 6 months postpartum

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: 300 mg of ZDV was given twice daily from 34 weeks gestation until labor then every 3 hours until delivery; 200 mg of NVP was given as a single oral dose at the onset of labor; and a single 2 mg/kg (6 mg if birthweight \> 2.5 kg) oral dose of NVP suspension was administered to the infant within 72 hours of delivery. intervention 2: 300 mg of zidovudine (ZDV), 150 mg of lamivudine, and 200 mg nevirapine (NVP) was given twice daily from 34 weeks gestation until six months after delivery.

intervention 1: Combined short-course zidovudine/nevirapine intervention 2: HAART

1

Nairobi | N/A | Kenya | 36.81667 | -1.28333

0

NCT00167674

[ 3 ]

41

RANDOMIZED

PARALLEL

2DIAGNOSTIC

4QUADRUPLE

false

0ALL

true

The aim of the study is to investigate the efficacy and safety of EGb 761® in patients with the primary Raynaud phenomenon, with regards to the frequency, duration and severity of vasospastic attacks.

Despite more than 150 years of research into the pathophysiology of Raynaud´s phenomenon it is still not understood sufficiently. Three mean mechanisms responsible for Raynaud´s phenomenon are discussed and fall into the following three categories: * neurological malfunction * pathological blood vessel wall and blood cell interactions * inflammatory and immunological responses Based on these concepts different classes of drugs have been tested. Although some therapies have shown effects, prolongation of the therapy is often difficult due to side-effects. Considering a prevalence of 5-10% in the general population, there is still a place and probably a need for the development of new treatment concepts. Ginkgo biloba has shown to have anti-oxidative and anti-platelet activities. In a small placebo controlled trial in patients with the Raynaud´s phenomenon promising results for the Ginkgo biloba extract were shown. EGb 761® is known to be safe and well tolerated. Based on the above considerations, EGb 761® may be an effective treatment for Raynaud´s phenomenon. Aim: To determine the efficacy and safety of EGb 761® in patients with Raynaud´s phenomenon on the frequency, duration, and severity of vasospastic attacks compared to placebo.

Raynaud Disease

Raynaud´s phenomenon Vasospastic attacks Ginkgo biloba

null

2

arm 1: Receiving daily Ginkgo biloba extract EGb 761 arm 2: Receiving daily placebo

[ 0, 2 ]

1

[ 0 ]

intervention 1: daily Ginkgo biloba extract EGb 761

intervention 1: Ginkgo biloba extract EGb 761

1

Nijmegen | Gelderland | Netherlands | 5.85278 | 51.8425

0

NCT00251238

[ 3 ]

551

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of the study is to assess the efficacy comparability of cetirizine and levocetirizine, by comparing the effects of single intake of the two drugs to placebo in reducing symptoms of seasonal allergic rhinitis (SAR) in ragweed sensitive adult subjects exposed to ragweed pollen in an Environmental Exposure Unit.

null

Rhinitis Allergic Seasonal

Levocetirizine Xyzal Rhinitis Allergic Seasonal Ragweed

null

5

arm 1: A single dose of placebo was administered orally on Day 1. arm 2: A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1. arm 3: A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1. arm 4: A single dose of 5 mg of CTZ oral drops was administered orally on Day 1. arm 5: A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.

[ 2, 0, 0, 0, 0 ]

7

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

intervention 1: * Pharmaceutical form: Drops for oral administration * Route of administration: Oral use intervention 2: * Pharmaceutical form: Tablets for oral administration * Route of administration: Oral use intervention 3: * Pharmaceutical form: Tablets for oral administration * Route of administration: Oral use intervention 4: * Pharmaceutical form: Drops for oral administration * Concentration: 5 mg/ml * Route of administration: Oral use intervention 5: * Pharmaceutical form: Tablets for oral administration * Concentration: 5 mg * Route of administration: Oral use intervention 6: * Pharmaceutical form: Drops for oral administration * Concentration: 10 mg/ml * Route of administration: Oral use intervention 7: * Pharmaceutical form: Tablets for oral administration * Concentration: 10 mg * Route of administration: Oral use

intervention 1: Placebo drops intervention 2: Placebo tablets matching to levocetirizine intervention 3: Placebo tablets matching to cetirizine intervention 4: Levocetirizine drops intervention 5: Levocetirizine tablets intervention 6: Cetirizine drops intervention 7: Cetirizine tablets

1

Kingston | Ontario | Canada | -76.48098 | 44.22976

0

NCT00291642

[ 0 ]

2

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

Greater Occipital Nerve Blocks (GONB) are a common procedure used for the treatment of headache. The GONB procedure involves a series of injections into the greater occipital nerve (a spinal nerve located at the back of your head). The purpose of this study is to determine whether GONB is effective for the treatment of prolonged migraine attacks. This study is placebo controlled, which means that half of the patients participating will receive injections of active study drug (lidocaine plus bupivicaine) and half of the patients will receive injections of saline (placebo). The study is also blinded which means that neither you nor the study staff will know whether you received active study drug or placebo. The study remains blinded only for the first 30 minutes, at which point additional treatments (including GONB) can be administered at the discretion of your treating physician. 40 patients are expected to participate in this research study. This study is being conducted at Thomas Jefferson University only.

null

Migraine

null

2

arm 1: None arm 2: matching volume of saline injected

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: The injectors will infiltrate an area of 2cm along the occipital ridge centering around the occipital artery or around the site 1/3 from the mastoid to the inion. If the subject has a bilateral headache or the headache is known to switch sides then the block will be performed bilaterally. If the headache is strictly unilateral, the block will be performed only on the side of the headache intervention 2: matching volume of saline (placebo)

intervention 1: 0.5% bupivicaine and 2% lidocaine intervention 2: Saline placebo

1

Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238

0

NCT00329732

[ 3 ]

126

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

Allergic rhinitis(AR) is one of the most common allergic disorders throughout the world.The conventional therapies are effective in alleviating symptoms but the efficacy are limited and not persistent. Furthermonre, the cost and side-effect are known defects. A classical Chinese herbal formula, has been used for AR for centries. Our study purpose is to evaluate the clinical efficacy and safety of this formula verus placebo in perennial allergic rhinitis (PAR). Hypothesis: the classical herbal formula would improve the symptoms of PAR patients and change some immunological parameters in the peripheral blood when comparing with the placebo.

It is a randomized, double-blind, placebo-controlled trial.

Perennial Allergic Rhinitis

Perennial Allergic rhinitis Traditional Chinese Medicine

null

2

arm 1: Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba). arm 2: The placebo contained brown colored starch resembling the SBL powder

[ 1, 2 ]

2

[ 0, 10 ]

intervention 1: 4 weeks of treatment, dose of 1 g (two capsules), twice daily intervention 2: 4 weeks of colormatched placebo capsules, dose of 1 g (two capsules), twice daily

intervention 1: Shi-Bi-Lin intervention 2: Placebo

2

Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832 Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832

0

NCT00456755

[ 2 ]

36

RANDOMIZED

CROSSOVER

null

0NONE

true

0ALL

null

The objective of this study is to compare the rate and extent of absorption of two Tramadol Contramid® OAD 300 mg controlled-release tablets from two different manufacturing sites, administered as 1 x 300 mg controlled-release tablet under fasting conditions. The effect of food on the to-be-marketed formulation was also assessed.

null

Healthy

Healthy Subjects

null

3

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

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: 1x300mg Tramadol Hydrochloride (HCl) tablet (Confab Laboratories), fasting condition. Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule. Results are presented per treatment group overall. intervention 2: 1x300mg Tramadol Hydrochloride (HCl) tablet (Confab Laboratories), fed condition. Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule. Results are presented per treatment group overall. intervention 3: 1x300mg Tramadol Hydrochloride (HCl) tablet (Trillium Healthcare) fasting condition. Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule. Results are presented per treatment group overall.

intervention 1: Tramadol hydrochloride intervention 2: Tramadol HCl intervention 3: Tramadol HCl

0

null

0

NCT00834912

[ 4 ]

43

RANDOMIZED

CROSSOVER

0TREATMENT

1SINGLE

false

0ALL

false

The objective of this study is to investigate the pharmacodynamics (as expressed in intraocular pressure \[IOP\]) of two formulations of tafluprost 0.0015% eyedrops (preserved and unpreserved) in patients with open-angle glaucoma or ocular hypertension. The primary aim of this study is to show that IOP reduction between the two formulations is equivalent at the end of the 4 week treatment period.

null

Open-Angle Glaucoma Ocular Hypertension

Ocular hypertension

null

2

arm 1: None arm 2: None

[ 0, 0 ]

1

[ 0 ]

intervention 1: Eye drops, 0.015 mg/ml, once daily to affected eye(s)

intervention 1: Tafluprost 0.0015%

3

Oulu | N/A | Finland | 25.46816 | 65.01236 Regensburg | N/A | Germany | 12.10161 | 49.01513 Starnberg | N/A | Germany | 11.34416 | 48.00193

0

NCT00918346

[ 3 ]

477

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

The primary trial objective is to determine the clinically effective dose of orally administered pyronaridine/artesunate (Pyramax®, PA) with a 3:1 ratio to treat adults with acute, symptomatic, uncomplicated P. falciparum malaria in South East Asia and Africa. Secondary trial objectives are to determine the safety of once-daily dosing for 3 days of PA and to explore possible ethnic differences in safety or efficacy.

This is a double-blind, multicentre, randomized, parallel group, dose-finding study of the efficacy, safety and tolerability of a once-daily 3-day regimen of PA with a 3:1 weight/weight ratio for patients with acute, symptomatic, uncomplicated P. falciparum malaria. Patients will be recruited from 5 to 7 study sites in endemic regions of South East Asia and Africa and will be randomized to 1 of 3 treatment groups differing in dosage, with 160 patients per group (n-480). Randomization will be balanced within each study site across all 3 study groups in pre-assigned treatment blocks. The first dose will be administered on Day 0 and patients will remain hospitalized for at least 4 days whilst undertaking the 3-day regimen. Patients will remain near the study site for a minimum of 7 days or once fever and parasite clearance is confirmed (assessed by 3 negative readings of fever and/or slide). The primary efficacy end point is the cure rate on Day 28 - the proportion of patients with PCR-corrected adequate clinical and parasitological response (ACPR). Despite this Day 28 end point, the relatively long half-life of pyronaridine necessitates follow-up until Day 42. In the case of adverse events reported and unresolved at Day 42, patients will be followed up for a further 30 days, or until resolution of the event.

Plasmodium Falciparum Malaria

malaria antimalarial artemisinin based combination therapy (ACT) pyronaridine artesunate (Pyramax)

null

3

arm 1: pyronaridine tetraphosphate 6 mg/kg and artesunate 2 mg/kg arm 2: pyronaridine tetraphosphate 9 mg/kg and artesunate 3 mg/kg arm 3: pyronaridine tetraphsophate 12 mg/kg and artesunate 4 mg/kg

[ 0, 0, 0 ]

1

[ 0 ]

intervention 1: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1. The tablets were taken daily for 3 days.

intervention 1: pyronaridine/artesunate

6

Pailin | N/A | Cambodia | 102.60928 | 12.84895 Tomohon | North Sulawesi | Indonesia | 124.80379 | 1.31678 Guédiawaye | N/A | Senegal | -17.40212 | 14.77446 Bangkok | N/A | Thailand | 100.50144 | 13.75398 Farafenni | N/A | The Gambia | -15.6 | 13.56667 Mbarara | N/A | Uganda | 30.64851 | -0.60467

0

NCT01594931

[ 3 ]

35

null

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to characterize the pharmacokinetics of Eslicarbazepine acetate in children and adolescents with epilepsy.

This clinical study was planned to be performed as an open-label, single-centre, multiple-dose study, in 30 paediatric epileptic patients distributed by 3 age groups of 10 patients each: 2-6 years \[Group 1\], 7-11 years \[Group 2\], and 12-17 years \[Group 3\]. The study was constituted by a 4-week baseline phase, followed by 3 consecutive 4-week treatment periods with Eslicarbazepine acetate in which patients received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day (weeks 1-4), 15 mg/kg/day (weeks 5-8) and 30 mg/kg/day or 1800 mg/day, whichever less (weeks 9-12). At the end of each 4-week treatment period, patients were hospitalised and serial blood samples for drug assays were obtained over a dosing interval. After the last treatment period or in the event of premature discontinuation, the dose had to be down-titrated during a 2-week period. After the last treatment period patient could continue receiving Eslicarbazepine acetate ("compassionate use") if both parent(s)/guardian(s) /patient and his/her physician agreed this was in the best patient's interest. A follow-up visit occurred approximately 4 weeks after the last hospitalisation or early discontinuation.

Epilepsy

Epilepsy BIA 2-093

null

3

arm 1: At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5-8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9-12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate ("compassionate use") if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient's interest. For Group 1 (2-6 years), oral suspension 50 mg/mL was used. The dose was to be rounded to the nearest 25 mg unit. arm 2: At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5-8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9-12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate ("compassionate use") if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient's interest. For Group 2 (7-11 years) and Group 3 (12-17 years), Eslicarbazepine acetate strengths 200 mg, 400 mg, 600 mg and 800 mg tablets might be used. The dose was to be rounded to the nearest 100 mg unit. Half tablets might be used for dosage adjustment (tablets were scored). arm 3: At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5-8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9-12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate ("compassionate use") if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient's interest. For Group 2 (7-11 years) and Group 3 (12-17 years), Eslicarbazepine acetate strengths 200 mg, 400 mg, 600 mg and 800 mg tablets might be used. The dose was to be rounded to the nearest 100 mg unit. Half tablets might be used for dosage adjustment (tablets were scored).

[ 0, 0, 0 ]

1

[ 0 ]

intervention 1: Eslicarbazepine acetate administered at increasing daily doses of 5 mg/kg, 15 mg/kg, and 30 mg/kg (or 1800 mg, whichever less); once-daily; oral route

intervention 1: BIA 2-093 (Eslicarbazepine acetate)

1

Bucharest | N/A | Romania | 26.10626 | 44.43225

0

NCT02170064

[ 2 ]

19

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of rhuMab 2C4 (Perjeta) and docetaxel (Taxotere) in participants with advanced solid tumors that have progressed during or after standard therapy, or for which no standard therapy is available. Participants will be enrolled and evaluated for dose-limiting toxicities (DLTs) in escalating-dose cohorts in order to determine the maximum tolerated dose (MTD).

null

Solid Tumor

null

3

arm 1: Docetaxel will be administered via intravenous (IV) infusion on Day 1 of each 3-week cycle at a dose of 100 mg/m\^2 per day, and rhuMab 2C4 will be given on Day 1 of each 3-week cycle as a fixed-dose 420-mg IV infusion. For Cycle 1 only, rhuMab 2C4 administration will be delayed to Day 2 with an initial 840-mg loading dose. The incidence of DLTs will be used to guide intrapatient dose modification, as well as subsequent enrollment. arm 2: Docetaxel will be administered via IV infusion on Day 1 of each 3-week cycle at a dose of 60 mg/m\^2 per day, and rhuMab 2C4 will be given on Day 1 of each 3-week cycle as a fixed-dose 420-mg IV infusion. For Cycle 1 only, rhuMab 2C4 administration will be delayed to Day 2 with an initial 840-mg loading dose. The incidence of DLTs will be used to guide intrapatient dose modification, as well as subsequent enrollment. arm 3: Docetaxel will be administered via IV infusion on Day 1 of each 3-week cycle at a dose of 75 mg/m\^2 per day, and rhuMab 2C4 will be given on Day 1 of each 3-week cycle as a fixed-dose 420-mg IV infusion. For Cycle 1 only, rhuMab 2C4 administration will be delayed to Day 2 with an initial 840-mg loading dose. The incidence of DLTs will be used to guide intrapatient dose modification, as well as subsequent enrollment.

[ 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: Participants will receive docetaxel on Day 1 of each 3-week cycle as 60, 75, or 100 mg/m\^2 via IV infusion. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal. intervention 2: Participants will receive rhuMab 2C4 on Day 1 of each 3-week cycle as 420 mg via IV infusion. For Cycle 1 ony, rhuMab will be administered on Day 2, at least 24 hours after docetaxel and following an initial 840-mg loading dose. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.

intervention 1: Docetaxel intervention 2: RhuMab 2C4

2

Rotterdam | N/A | Netherlands | 4.47917 | 51.9225 Sutton | N/A | United Kingdom | -0.2 | 51.35

0

NCT02490475

[ 2, 3 ]

78

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The primary purpose of this study is to assess the safety and efficacy of interferon-gamma by subcutaneous injection in complex treatment of patients with co-infection of HIV and pulmonary tuberculosis and to determine the rational of its use.

Study will evaluate safety and efficacy of the investigational medical product (IMP) - interferon-gamma - in participants with HIV-infection and pulmonary tuberculosis. Interferon-gamma (immune interferon) is an important anti-inflammatory cytokine produced by NK-cells, CD4 Th1 cells and CD8 cytotoxic supressor cells. Interferon-gamma blocks viral replication, viral proteins synthesis and assembly of mature viral particles. Causes cytotoxic effects on the cells infected by intracellular pathogens. Possess a bright immunomoduling action. Thus, the use of interferon-gamma is patogenetically rational in patients co-infected with tuberculosis and HIV. The aim of interferon-gamma use is to achieve a viral replication control, support CD4 level and help abacillation process. In this randomised, controlled safety and efficacy study interferon gamma will be administered in a daily dose of 500,000 IU daily or every other day. The treatment regimen in this study will also include a basic antituberculosis therapy. The available clinical data do not suggest a risk for serious adverse events (SAEs) from the IMP used in chosen doses. The study will screen HIV-infected participants 18-50 years old with pulmonary tuberculosis. Participants who provide informed consent and meet study entry criteria will be randomised into 1 of 3 parallel treatment groups. The study will last 30 days, during which participants will receive IMP in various regimens according to the group.

HIV Coinfection Aids/Hiv Problem Tuberculosis, Pulmonary Human Immunodeficiency Virus Lentivirus Infections RNA Virus Infections

interferon gamma, IFN-g, HIV infection, tuberculosis

null

3

arm 1: All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU alternated with Interal® (interferon alpha) 3,000,000 IU every other day Interventions: Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy arm 2: All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU given with Interal® (interferon alpha) 3,000,000 IU every day Interventions: Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy arm 3: All participants receive only basic antimicrobial treatment Interventions: Drug: Antituberculosis complex therapy

[ 0, 0, 4 ]

1

[ 0 ]

intervention 1: received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein

intervention 1: Interferon-Gamma

2

0

NCT05065905

[ 5 ]

248

RANDOMIZED

PARALLEL

0TREATMENT

null

false

0ALL

false

During this study, your child will need to attend up to 5 office visits and maintain regular telephone contact with the clinic. Certain office visits will include physical exams, medical history review, exercise challenge test (walking/running on a treadmill), electrocardiogram (ECG) tests, and lung function tests. All study related medications and medical examinations are provided at no cost. All study drugs are currently available by prescription to patients 4 years and older.

null

Bronchospasm Activity/Exercise Induced Bronchospasm

asthma bronchospasm

null

2

arm 1: Participants received FSC 100/50 microgram (mcg) one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days arm 2: Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Fluticasone propionate/salmeterol intervention 2: Fluticasone Propionate

50

0

NCT00118716

[ 2 ]

9

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This was a Phase 1, single-arm, open-label, pilot study of NY-ESO-1 protein vaccination with imiquimod as an adjuvant in patients with resected Stage IIB, IIC, and III malignant melanoma. The primary study objective was to determine the safety of NY-ESO-1 protein/imiquimod treatment, and the secondary objective was to evaluate the immunogenicity of treatment.

Patients applied imiquimod (250 mg) topically to a designated area of healthy skin on the upper inner arm or inner thigh (the cream remained on the skin overnight for 6-10 hours) every day for 5 consecutive days (i.e., for the first 5 days of Cycles 1-3 and for the first 4 days of Cycle 4). The NY-ESO-1 protein (100 μg) was injected intradermally into the imiquimod-pretreated area on Day 3 of each cycle for 4 consecutive 21-day cycles. Safety was monitored continuously. Immunization was assessed by the generation of NY-ESO-1-specific cluster of differentiation (CD)4+ and CD8+ T cell responses in enzyme-linked immunosorbent spot (ELISPOT) assays and by the development or augmentation of NY-ESO-1-specific antibody titers, assessed by enzyme-linked immunosorbent assay (ELISA). Blood samples were obtained for the assessment of clinical biochemistry and hematology, and physical examinations were performed at baseline, on Day 1 of each cycle, and at a follow-up visit at Week 13. Skin biopsies of the vaccinated area were obtained 48 hours after the last injection (Day 5 of Cycle 4). To avoid irritation, imiquimod was not applied after the biopsies.

Malignant Melanoma

Malignant melanoma Stages IIB-III

null

1

arm 1: Patients applied topical imiquimod followed by vaccination with intradermal injections of the NY-ESO-1 protein.

[ 0 ]

2

[ 0, 2 ]

intervention 1: Patients applied imiquimod cream at bedtime every day for 5 consecutive days (for the first 5 days of Cycles 1-3 and for the first 4 days of Cycle 4) at a dose of 250 mg as supplied in single-use packets to a 4 x 5 cm area of healthy skin, alternating among the extremities (upper inner arms and inner thighs) in each cycle. The cream was to be rubbed into the skin until it was no longer visible. Patients were encouraged to wash their hands before and after applying cream. The application site was not occluded. The next morning, 6 to 10 hours after initial application, the treated area was washed with mild soap and water to remove any residual cream. intervention 2: NY-ESO-1 protein was injected intradermally by a study physician or nurse at a dose of 100 μg into the imiquimod-pretreated area on Day 3 of each cycle for 4 consecutive 21-day cycles.

intervention 1: Imiquimod intervention 2: NY-ESO-1 protein

1

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

0

NCT00142454

[ 4 ]

521

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus.

null

Diabetes Mellitus, Type 2

null

3

arm 1: Sitagliptin 100 mg arm 2: Sitagliptin 200 mg arm 3: Placebo/Pioglitazone

[ 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: sitagliptin 100 mg oral tablet once daily for 54 weeks intervention 2: sitagliptin 200 mg (2- 100 mg oral tablets) once daily for 54 weeks intervention 3: placebo oral tablet once daily during Phase A (Weeks 0-18) intervention 4: pioglitazone 30 mg oral tablet once daily during Phase B (Weeks 18-54)

intervention 1: Comparator: sitagliptin 100 mg intervention 2: Comparator: sitagliptin 200 mg intervention 3: Comparator: placebo intervention 4: Comparator: pioglitazone

0

null

0

NCT00094757

[ 5 ]

104

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Objective(s) The primary study objective is to assess the antiviral effect of 12 weeks of adefovir dipivoxil treatment in Korean patients with chronic hepatitis B and compensated liver disease. The secondary study objectives are to assess the antiviral effect, clinical benefit and safety of 52 weeks of adefovir dipivoxil treatment. Endpoint(s) The primary efficacy endpoint is "Mean log10 reduction in serum HBV DNA level from baseline to Week 12". The secondary efficacy endpoints include (a) the proportion of patients achieving serum ALT normalization at Week 52, (b) other assessments of antiviral effects (the proportion of patients achieving HBV DNA no less than 300 copies per mL at Week 52), (c)HBeAg loss, HBeAg seroconversion, HBsAg loss and HBsAg seroconversion, (d)the proportion of patients achieving serum ALT normalization at Week 12. Study Design This is an open label, multi centre phase IV study for Korean patients with chronic hepatitis B and compensated liver disease, assessing the antiviral effect of 12 weeks treatment of Adefovir dipivoxil as a primary objective and antiviral effect, clinical benefit and safety of 52 weeks treatment as secondary objectives. Patients will be screened for eligibility criteria and the baseline visit for the treatment initiation should occur no more than 4 weeks after screening. Total treatment period will be 52 weeks and patients will return to the clinic for assessments as scheduled during treatment period. After the 52 week study period, it is likely that the patient will benefit from continued treatment with commercial adefovir. If in the investigator's clinical judgement this is the case, the investigator should ensure that a routine prescription is available in a timely manner, and that no unnecessary interruption in treatment occurs. Study Population A minimum of 100 male or female Korean patients more than 18 years of age with HBeAg positive chronic hepatitis B and compensated liver disease who meet the eligibility criteria will be enrolled. Study Assessments and Procedures Potential patients will be screened prior to study entry and eligible patients who have given their consent will have further baseline assessments. Following the screening, the first doses of study medications will be given at baseline and patients will return to the clinic for assessment as scheduled during treatment period. Patients who discontinue treatment prematurely will be followed up every 4 weeks for 12 weeks following the withdrawal visit. The following key assessment and or measurement will be made at one or more visits during the study. (See section 14.1 Appendix 1. Time and event schedule): * Pregnancy test (females of child-bearing potential only) * Haematology and serum chemistry profile including prothrombin time(PT) and AFP * HBV DNA (Roche COBAS AMPLICOR HBV MONITOR Test, LLOD 300 copies per ml) * Hepatitis B markers: HBeAg(Anti HBe will be tested if HBeAg is negative), HBsAg(Anti HBs will be tested if HBsAg is negative) Investigational Product(s) Adefovir dipivoxil 10mg tablets will be supplied by GlaxoSmithKline and presented as a white to off white, round tablets, packaged in the bottle containing 30 tablets

null

Hepatitis B, Chronic

null

1

arm 1: All enrolled subject were enrolled to adefovir dipivoxil 10mg arm.

[ 0 ]

1

[ 0 ]

intervention 1: All enrolled subjects were enrolled to adefovir dipivoxil arm.

intervention 1: Adefor dipivoxil

0

null

0

NCT01205165

[ 4 ]

2,101

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

false

0ALL

null

A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsule s \[150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery\] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days, in prevention of venous thromboem bolism in patients with primary elective total knee replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)

null

Arthroplasty, Replacement, Knee Thromboembolism

null

3

arm 1: 220 mg once daily arm 2: 150 mg once daily arm 3: 40 mg once daily

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: 40 mg once daily intervention 2: 150 mg once daily intervention 3: 220 mg once daily

intervention 1: enoxaparin intervention 2: dabigatran etexilate intervention 3: dabigatran etexilate

105

Garren | Australian Capital Territory | Australia | N/A | N/A Kogarah | New South Wales | Australia | 151.13564 | -33.9681 Lismore | New South Wales | Australia | 153.2773 | -28.81354 Bedford Park | South Australia | Australia | 138.56815 | -35.02204 Toorak Gardens | South Australia | Australia | 138.63639 | -34.93478 Woodville | South Australia | Australia | 138.54291 | -34.877 Box Hill | Victoria | Australia | 145.12545 | -37.81887 Clayton | Victoria | Australia | 145.11667 | -37.91667 Malvern | Victoria | Australia | 145.02811 | -37.86259 Ringwood East | Victoria | Australia | 145.25 | -37.81667 Windsor | Victoria | Australia | 144.99241 | -37.85344 Perth | Western Australia | Australia | 115.8614 | -31.95224 Linz | N/A | Austria | 14.28611 | 48.30639 Vienna | N/A | Austria | 16.37208 | 48.20849 Wels | N/A | Austria | 14.03333 | 48.16667 Wiener Neustadt | N/A | Austria | 16.23196 | 47.80485 Brussels | N/A | Belgium | 4.34878 | 50.85045 Genk | N/A | Belgium | 5.50082 | 50.965 Ghent | N/A | Belgium | 3.71667 | 51.05 Ghent | N/A | Belgium | 3.71667 | 51.05 Hasselt | N/A | Belgium | 5.33781 | 50.93106 Herentals | N/A | Belgium | 4.83248 | 51.17655 Lanaken | N/A | Belgium | 5.6468 | 50.89318 Leuven | N/A | Belgium | 4.70093 | 50.87959 Brno-Bohunice | N/A | Czechia | N/A | N/A Chomutov | N/A | Czechia | 13.41779 | 50.46048 Havlíčkův Brod | N/A | Czechia | 15.57937 | 49.6069 Kladno | N/A | Czechia | 14.10285 | 50.14734 Kolín | N/A | Czechia | 15.1998 | 50.02806 Ostrava | N/A | Czechia | 18.28204 | 49.83465 Pilsen | N/A | Czechia | 13.37759 | 49.74747 Pradubice | N/A | Czechia | N/A | N/A Prague | N/A | Czechia | 14.42076 | 50.08804 Hellerup | N/A | Denmark | 12.57093 | 55.73204 Hørsholm | N/A | Denmark | 12.50111 | 55.88098 København NV | N/A | Denmark | 12.52343 | 55.71258 København S | N/A | Denmark | 12.5978 | 55.65059 Silkeborg | N/A | Denmark | 9.54508 | 56.1697 Helsinki | N/A | Finland | 24.93545 | 60.16952 Jyväskylä | N/A | Finland | 25.72088 | 62.24147 Oulu | N/A | Finland | 25.46816 | 65.01236 Seinäjoki | N/A | Finland | 22.82822 | 62.79446 Amiens | N/A | France | 2.3 | 49.9 Annecy | N/A | France | 6.12565 | 45.90878 La Rochelle | N/A | France | -1.15222 | 46.16308 Paris | N/A | France | 2.3488 | 48.85341 Poitiers | N/A | France | 0.34348 | 46.58261 Roubaix | N/A | France | 3.17456 | 50.69421 Saint-Etienne | N/A | France | 4.39 | 45.43389 Soyaux | N/A | France | 0.19752 | 45.64052 Strasbourg | N/A | France | 7.74553 | 48.58392 Bad Mergentheim | N/A | Germany | 9.77361 | 49.4925 Erlangen | N/A | Germany | 11.00783 | 49.59099 Frankfurt | N/A | Germany | 10.53333 | 49.68333 Garmisch-Partenkirchen | N/A | Germany | 11.09576 | 47.49209 Halle | N/A | Germany | 11.97947 | 51.48158 Markgröningen | N/A | Germany | 9.08059 | 48.90493 Rheinfelden | N/A | Germany | 7.78715 | 47.56013 Sommerfeld | N/A | Germany | 13.0014 | 54.36652 Wiesbaden | N/A | Germany | 8.24932 | 50.08258 Békéscsaba | N/A | Hungary | 21.1 | 46.68333 Budapest | N/A | Hungary | 19.04045 | 47.49835 Gyula | N/A | Hungary | 21.28333 | 46.65 Kecskemét | N/A | Hungary | 19.69128 | 46.90618 Szeged | N/A | Hungary | 20.14824 | 46.253 Székesfehérvár | N/A | Hungary | 18.41034 | 47.18995 Bologna | N/A | Italy | 11.33875 | 44.49381 Parma | N/A | Italy | 10.32618 | 44.79935 Pavia | N/A | Italy | 9.15917 | 45.19205 Piacenza | N/A | Italy | 9.69342 | 45.05242 Reggio Emilia | N/A | Italy | 10.63125 | 44.69825 Treviso | N/A | Italy | 12.2416 | 45.66673 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Hilversum | N/A | Netherlands | 5.17639 | 52.22333 Hoofddorp | N/A | Netherlands | 4.68889 | 52.3025 Nijmegen | N/A | Netherlands | 5.85278 | 51.8425 Sittard | N/A | Netherlands | 5.86944 | 50.99833 Zwolle | N/A | Netherlands | 6.09444 | 52.5125 Kielce | N/A | Poland | 20.62752 | 50.87033 Krakow | N/A | Poland | 19.93658 | 50.06143 Krakow | N/A | Poland | 19.93658 | 50.06143 Warsaw | N/A | Poland | 21.01178 | 52.22977 Bryanston | N/A | South Africa | 28.02805 | -26.05211 Randburg | N/A | South Africa | 28.00123 | -26.0941 Sandton | N/A | South Africa | 28.054 | -26.104 Alcorcón (Madrid) | N/A | Spain | -3.82487 | 40.34582 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Hospitalet (Barcelona) | N/A | Spain | N/A | N/A Jaén | N/A | Spain | -3.79028 | 37.76922 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Móstoles (Madrid) | N/A | Spain | -3.86496 | 40.32234 Valencia | N/A | Spain | -0.37966 | 39.47391 Falköping | N/A | Sweden | 13.55068 | 58.17347 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Halmstad | N/A | Sweden | 12.85676 | 56.67446 Kungälv | N/A | Sweden | 11.98054 | 57.87096 Lidköping | N/A | Sweden | 13.15765 | 58.50517 Linköping | N/A | Sweden | 15.62157 | 58.41086 Mölndal | N/A | Sweden | 12.01378 | 57.6554 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Varberg | N/A | Sweden | 12.25078 | 57.10557

0

NCT00168805

[ 5 ]

308

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

null

This study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment. The anticipated time on study treatment is 6 months, and the target sample size is 360 individuals.

null

Post Menopausal Osteoporosis

null

2

arm 1: Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 1 will receive a physician consultation after 4 months of treatment to review bone turnover test results. arm 2: Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 2 will not receive a physician consultation.

[ 0, 0 ]

1

[ 0 ]

intervention 1: Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.

intervention 1: Ibandronate

53

1

NCT02598934

[ 3 ]

35

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether the effectiveness of celecoxib in treating glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and undergoing radiation therapy. PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who are receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed glioblastoma multiforme.

OBJECTIVES: Primary * Determine the effects of hepatic enzyme-inducing drugs, such as anticonvulsants, on the pharmacokinetics of celecoxib in patients with newly diagnosed glioblastoma multiforme undergoing radiotherapy. * Determine the effects of steroids on the pharmacokinetics of celecoxib in these patients. Secondary * Determine the safety of celecoxib in these patients. * Determine the duration of survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups based on anticonvulsant therapy. * Group A: Patients treated with any of the following anticonvulsant drugs that induce hepatic metabolic enzymes: * Phenytoin * Carbamazepine * Phenobarbital * Primidone * Oxcarbazepine * Group B: Patients treated with any of the following anticonvulsant drugs that cause modest or no induction of hepatic metabolic enzymes OR no anticonvulsant drug: * Gabapentin * Lamotrigine * Valproic acid * Levetiracetam * Tiagabine * Topiramate * Zonisamide * Felbamate * Induction therapy: Patients in both groups receive oral celecoxib twice\* daily on weeks 1-11 and undergo radiotherapy 5 days a week on weeks 2-7. * Maintenance therapy: Patients receive oral celecoxib twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. NOTE: \*Patients receive only 1 dose on the first day of celecoxib administration. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 44 patients (22 per group) will be accrued for this study within approximately 8 months.

Brain and Central Nervous System Tumors

adult glioblastoma adult giant cell glioblastoma adult gliosarcoma

null

2

arm 1: on p450 inhibitor (Patients taking anttiseizure drugs that are known to induce the hepatic drug-metabolizing enzymes - including phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine) celecoxib and radiation therapy will be adminstered with this arm arm 2: not on p450 inhibitor (Patients either NOT taking anti-seizure drugs or ones that are known to not significantly influence the hepatic drug-metabolizing enzymes - including gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine,topiramate, zonisamide and filbamate. celecoxib and radiation therapy will be adminstered with this arm

[ 1, 1 ]

2

[ 4, 0 ]

intervention 1: Radiation is standard treatment 6000cGy in 30 fractions. Patients will receive celecoxib 400 mg bid during RT treatment intervention 2: Celecoxib will begin 1 week prior to RT at 400mg bid orally. One day 1 only 1 dose will be administered. Starting on day 2 and throughout treatment until progression, 2 doses will be administered at least 12 hours apart. Celecoxib will continue throughout the 6 week course of RT.

intervention 1: radiation therapy intervention 2: Celecoxib

7

0

NCT00068770

[ 4 ]

462

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

2MALE

false

A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.

This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia. the following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the Internation Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.

Benign Prostatic Hyperplasia

Benign prostatic hyperplasia, alpha blocker

null

2

arm 1: Silodosin 8 mg/Day with food arm 2: Matching placebo capsule once daily with food

[ 0, 2 ]

2

[ 0, 10 ]

intervention 1: 8 mg daily for 12 weeks intervention 2: One capsule daily for 12 weeks

intervention 1: Silodosin intervention 2: Placebo

42

0

NCT00224120

[ 3 ]

420

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this study is to investigate the efficacy and safety of an MK 0974 for migraine headache and to identify an appropriate dose range for further study.

null

Migraine

null

9

arm 1: Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache. arm 2: MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. arm 3: MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. arm 4: MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. arm 5: MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. arm 6: MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. arm 7: MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. arm 8: MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. arm 9: Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

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

9

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

intervention 1: Placebo to match assigned treatment arm; one orally-administered dose intervention 2: MK0974 25 mg; one orally-administered dose intervention 3: MK0974 50 mg; one orally-administered dose intervention 4: MK0974 100 mg; one orally-administered dose intervention 5: MK0974 200 mg; one orally-administered dose intervention 6: MK0974 300 mg; one orally-administered dose intervention 7: MK0974 400 mg; one orally-administered dose intervention 8: MK0974 600 mg; one orally-administered dose intervention 9: Rizatriptan 10 mg; one orally-administered dose

intervention 1: Comparator: Placebo intervention 2: MK0974 intervention 3: MK0974 intervention 4: MK0974 intervention 5: MK0974 intervention 6: MK0974 intervention 7: MK0974 intervention 8: MK0974 intervention 9: Rizatriptan

0

null

0

NCT00246337

[ 5 ]

36

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This is a randomized, double-blind, double-dummy, placebo-controlled, parallel-group, single center study in subjects with positive histamine skin prick test and a positive RadioAllergoSorbent Test (RAST) (class \> 2) to one of the tested standardized allergenic extracts: tree pollen, cat dander, house dust mite, or a mixture of five grass pollens. Subjects will be randomized to desloratadine 5 mg once daily, levocetirizine 5mg once daily, or placebo once daily for 8 days of treatment followed by 11 days of skin testing after discontinuation of the antihistamine treatment phase. The duration of the suppressive effects of desloratadine on cutaneous allergen-induced wheal and flare responses after discontinuation of a one-week treatment will be established.

null

Hypersensitivity

Histamine H1 Antagonists Anti-Allergic Agents

null

3

arm 1: Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). arm 2: Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). arm 3: Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).

[ 0, 1, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 5 mg tablet once daily intervention 2: 5 mg capsule once daily intervention 3: once daily intervention 4: once daily

intervention 1: desloratadine intervention 2: levocetirizine intervention 3: Desloratadine placebo tablet intervention 4: Levocetirizine placebo capsule

0

null

0

NCT00359138

[ 4 ]

466

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

Korean double-blind non-inferiority study to asses the efficacy (as measured by the responder rate of pruritus severity score by the patient at visit 4 or end-of-treatment visit over the 2 weeks treatment period) and safety of Xyzal® to Zyrtec® in subjects suffering from dermatitis and eczema with pruritus symptoms

null

Dermatitis Eczema

Dermatitis Eczema Pruritus Xyzal Zyrtec Levocetirizine Cetirizine

null

2

arm 1: Levocetirizine + Cetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days arm 2: Cetirizine + Levocetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days

[ 0, 1 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: 1 Levocetirizine 5mg tablet per day before bedtime for 14 days intervention 2: 1 Cetirizine 10mg tablet per day before bedtime for 14 days. intervention 3: 1 Placebo-Levocetirizine tablet per day before bedtime for 14 days intervention 4: 1 Placebo-Cetirizine tablet per day before bedtime for 14 days intervention 5: 1% hydrocortisone ointment, applied 2-3 times a day to all affected areas

intervention 1: Levocetirizine intervention 2: Cetirizine intervention 3: Placebo-Levocetirizine intervention 4: Placebo-Cetirizine intervention 5: Standard topical steroid (1% hydrocortisone) ointment

3

Gyeunggi-do | N/A | South Korea | N/A | N/A Kyeonggi-Do | N/A | South Korea | N/A | N/A Seoul | N/A | South Korea | 126.9784 | 37.566

0

NCT00375713

[ 2 ]

16

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

true

0ALL

false

The purpose of this study is to evaluate the tolerability and pharmacokinetics of three doses of MAP0010 (Unit Dose Budesonide) compared with Pulmicort Respules® (Budesonide) in healthy volunteers.

null

Asthma

Pediatric asthma

null

4

arm 1: Treatment visits were separated by a 48-72 hour washout period. Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 2; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 3; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 4; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 5 arm 2: Treatment visits were separated by a 48-72 hour washout period. Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 2; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 3; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 4; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 5 arm 3: Treatment visits were separated by a 48-72 hour washout period. Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 2; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 3; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 4; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 5 arm 4: Treatment visits were separated by a 48-72 hour washout period. Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 2; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 3; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 4; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 5

[ 0, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Treatment A = a single dose of Pulmicort Respules® (budesonide inhalation suspension) delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol. intervention 2: Treatment B = a single dose of MAP0010 (unit dose budesonide) low dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol. intervention 3: Treatment C = a single dose of MAP0010 (unit dose budesonide) intermediate dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol. intervention 4: Treatment D = a single dose of MAP0010 (unit dose budesonide) high dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.

intervention 1: Budesonide Inhalation Suspension intervention 2: MAP0010 low dose intervention 3: MAP0010 intermediate dose intervention 4: MAP0010 high dose

1

Brisbane | Queensland | Australia | 153.02809 | -27.46794

0

NCT00627679

[ 3 ]

292

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This 4 arm study will evaluate the efficacy and safety of RO4607381 when co-administered with pravastatin in patients with low or relatively low HDL-C levels. Patients will be randomised to one of 4 groups to receive either RO4607381 300mg, 600mg or 900mg po daily, or placebo po daily, for 12 weeks.All patients will also receive pravastatin 40mg po daily for 12 weeks.The anticipated time on study treatment is 3 months and the target sample size is 100-500 individuals.

null

Dyslipidemia

null

4

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

[ 0, 0, 0, 2 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: po daily for 12 weeks intervention 2: 40mg po daily for 12 weeks intervention 3: 300mg po daily for 12 weeks intervention 4: 600mg po daily for 12 weeks intervention 5: 900mg po daily for 12 weeks

intervention 1: Placebo intervention 2: Pravastatin intervention 3: Dalcetrapib intervention 4: Dalcetrapib intervention 5: Dalcetrapib

33

0

NCT00697203

[ 4 ]

594

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

false

The objective of this study is to evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia

Evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia

Anemia

null

2

arm 1: Day 0: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously. Day 7: for weight \>33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously. arm 2: Day 0: for weight \>33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously. Day 7: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously intervention 2: for weight \>33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously

intervention 1: VIT-45 intervention 2: Placebo

1

Norristown | Pennsylvania | United States | -75.3399 | 40.1215

0

NCT00740246

[ 2 ]

26

RANDOMIZED

CROSSOVER

null

1SINGLE

true

0ALL

false

This study investigated the relative bioavailability (rate and extent of absorption) of Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg by Teva Pharmaceuticals, USA with that of Aricept® Orally Disintegrating Tablets, Manufactured and Marketed by Eisai Inc., following a single oral dose (1 x 10 mg orally disintegrating tablet) in healthy adult subjects administered under fasting conditions.

null

Healthy

Bioequivalence Healthy Subjects

null

2

arm 1: Donepezil Hydrochloride 10 mg Orally Disintegrating Tablets arm 2: Aricept® 10 mg Orally Disintegrating Tablets

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 10 mg Orally Disintegrating Tablet intervention 2: 10 mg Orally Disintegrating Tablet

intervention 1: Donepezil Hydrochloride intervention 2: Aricept®

1

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

0

NCT01260922

[ 2 ]

26

RANDOMIZED

CROSSOVER

null

0NONE

true

0ALL

false

This study investigated the relative bioavailability (rate and extend of absorption) of Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg by Teva Pharmaceuticals, USA with that of Aricept® Orally Disintegrating Tablets, Manufactured and Marketed by Eisai Inc., following a single oral dose (1 x 10 mg orally disintegrating tablet) in healthy adult subjects administered under non-fasting conditions.

null

Healthy

Bioequivalence Healthy Subjects

null

2

arm 1: Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg arm 2: Aricept® Orally Disintegrating Tablets, 10 mg

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 10 mg Orally Disintegrating Tablet intervention 2: 10 mg Orally Disintegrating Tablet

intervention 1: Donepezil Hydrochloride intervention 2: Aricept®

1

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

0

NCT01260948

[ 3 ]

232

RANDOMIZED

PARALLEL

2DIAGNOSTIC

3TRIPLE

false

0ALL

false

The object of this study is to compare four different dosages of Gadavist 1.0 in cardiac Magnetic Resonance Tomography (MRT) imaging with the imaging results of a cardiac SPECT examination in terms of diagnostic quality. For this purpose Gadavist dosages of 0.01 mmol/kg, 0.025 mmol/kg, 0.05 mmol/kg or 0.1mmol/kg body weight are administered. A study participant receives the respective dose twice i.e. at rest and at stress using Adenosine (which puts circulation into a state of stress similar to that of physical exercise). The time between both injections is 10-15 min. The total imaging time is about 45 min.

null

Myocardial Perfusion Imaging Magnetic Resonance Imaging

Cardiac MRI gadobutrol

null

4

arm 1: Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg body weight (BW) (0.01mL/kg) for stress magnetic resonance imaging (MRI) via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI. arm 2: Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI. arm 3: Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI. arm 4: Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.

[ 0, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 0.01 mmol/kg BW (0.01 mL/kg) for stress MRI and 0.01 mmol/kg BW (0.01 mL/kg) for rest MRI (total dose 0.02 mmol/kg) intervention 2: 0.025 mmol/kg BW (0.025 mL/kg) for stress MRI and 0.025 mmol/kg BW (0.025 mL/kg) for rest MRI (total dose 0.05 mmol/kg) intervention 3: 0.05 mmol/kg BW (0.05 mL/kg) for stress MRI and 0.05 mmol/kg BW (0.05 mL/kg) for rest MRI (total dose 0.1 mmol/kg) intervention 4: 0.1 mmol/kg BW (0.1 mL/kg) for stress MRI and 0.1 mmol/kg BW (0.1 mL/kg) for rest MRI (total dose 0.2 mmol/kg)

intervention 1: Gadobutrol (Gadavist,Gadovist, BAY86-4875) intervention 2: Gadobutrol (Gadavist,Gadovist, BAY86-4875) intervention 3: Gadobutrol (Gadavist,Gadovist, BAY86-4875) intervention 4: Gadobutrol (Gadavist,Gadovist, BAY86-4875)

14

0

NCT01490294

[ 3 ]

64

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The primary objective of this trial is to establish the maximum maintenance dose of SPM 962 in patients with Parkinson's disease in a multi-center, uncontrolled, open-label study by conducting safety evaluation of each patient following once-daily transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg. (The administration period will consist of a standard 8-week dose-titration period, 4-week dose-maintenance period, and a dose de-escalation period) Exploratory evaluation of each patient's maintenance dose will also be conducted with attention to patient safety. The relationship of pharmacokinetics, safety, and efficacy will also be examined.

null

Parkinson's Disease

SPM 962 rotigotine Parkinson's disease

null

1

arm 1: SPM 962 transdermal patch

[ 0 ]

1

[ 0 ]

intervention 1: SPM 962 transdermal patch once a daily up to 36.0 mg/day

intervention 1: SPM 962

5

Kanto Region | N/A | Japan | N/A | N/A Kinki Region | N/A | Japan | N/A | N/A Kyushu Region | N/A | Japan | N/A | N/A Shikoku Region | N/A | Japan | N/A | N/A Tohoku Region | N/A | Japan | N/A | N/A

0

NCT01634243

[ 3 ]

31

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This trial will evaluate the efficacy and safety of ucb 44212 as add on therapy in subjects with focal epilepsy.

null

Epilepsy, Partial

Epilepsy Partial onset seizures Seletracetam

null

1

arm 1: Escalating doses twice daily were to be administered.

[ 0 ]

1

[ 0 ]

intervention 1: * Pharmaceutical form: oral capsules * Concentration: 10 and 50 mg * Route of administration: oral administration

intervention 1: Seletracetam (ucb 44212)

7

0

NCT00152451

[ 3 ]

59

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This trial will evaluate the efficacy and safety of UCB44212 as add-on therapy in subjects with focal epilepsy.

null

Epilepsy, Partial

Epilepsy Partial Onset Seizures Seletracetam Levetiracetam

null

1

arm 1: Escalating doses twice daily were to be administered.

[ 0 ]

1

[ 0 ]

intervention 1: * Pharmaceutical form: oral capsules * Concentration: 2, 10 and 50 mg * Route of administration: oral administration

intervention 1: Seletracetam (UCB44212)

17

0

NCT00152503

[ 4 ]

224

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The primary purpose of the study is to determine the time-course of recovery to a T4/T1 ratio of 0.9 within 4 minutes after 4.0 mg.kg\^-1 Sugammadex is administered at least 15 minutes after the last administration of rocuronium in a wide range of surgical procedures and anesthetic regimens (routine use). Safety evaluation is part of the study.

null

Anesthesia, General

null

1

arm 1: Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered.

[ 0 ]

2

[ 0, 0 ]

intervention 1: At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg Org 25969 was administered. intervention 2: Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was/were administered.

intervention 1: Sugammadex intervention 2: Rocuronium

0

null

0

NCT00298831

[ 5 ]

189

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

An open-label, multi-center study to establish psoriasis control of moderate to severe plaque psoriasis with Raptiva therapy administered subcutaneously for 24 weeks.

null

Candidates for Systemic Therapy for Psoriasis Psoriasis

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Subjects will receive a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.

intervention 1: Efalizumab

1

Geneva | N/A | Switzerland | 6.14569 | 46.20222

0

NCT00287118

[ 4 ]

2,615

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

false

0ALL

null

To determine the comparative efficacy and safety of two different doses (75mg day 1 followed by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of dabigatran administered orally (capsules), compared to enoxaparin 30 mg twice a day subcutaneous, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery

null

Arthroplasty, Replacement, Knee Thromboembolism

null

3

arm 1: low dose regimen taken once daily arm 2: high dose regimen taken once daily arm 3: 30 mg subcutaneously twice daily

[ 0, 0, 1 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: low dose regimen taken once daily intervention 2: low dose regimen taken once daily intervention 3: high dose regimen taken once daily intervention 4: high dose regimen taken once daily intervention 5: 30 mg subcutaneously twice daily

intervention 1: Dabigatran Dose 1 - day 2 to completion intervention 2: Dabigatran Dose 1 - day 1 intervention 3: Dabigatran Dose 2 - day 2 to completion intervention 4: Dabigatran Dose 2 - day 1 intervention 5: Enoxaparin

94

0

NCT00152971

[ 5 ]

418

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

An 8-week, open-label trial in 848 subjects at 212 sites to compare time to response in symptoms of anxiety in subjects treated with Niravam™ and a newly prescribed Selective Serotonin Reuptake Inhibitor (SSRI)or Serotonin and Norepinephrine Reuptake Inhibitor (SNRI) to that in subjects treated with a newly prescribed SSRI/SNRI alone. Subjects must be at least 18 years of age and positive for Generalized Anxiety Disorder (GAD)or Panic Disorder. Subjects will be randomized to receive concomitant Niravam™ and an SSRI/SNRI or an SSRI/SNRI alone during the study. Most symptom evaluations will be done using an automated phone interview system. There are 4 clinic visits.

null

Generalized Anxiety Disorder Panic Disorder

null

4

arm 1: Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI arm 2: Panic Disorder: Newly prescribed SSRI or SNRI alone arm 3: Generalized Anxiety Disorder: Niravam plus a newly prescribed SSRI or SNRI arm 4: Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

[ 0, 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: Selective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor

intervention 1: Niravam intervention 2: SSRI/SNRI

1

Milwaukee | Wisconsin | United States | -87.90647 | 43.0389

1

NCT00266409

[ 3 ]

5

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Cyclosporine and mycophenolate mofetil may prevent this from happening. PURPOSE: Phase II trial to study the effectiveness of chemotherapy and total-body irradiation followed by donor peripheral stem cell transplantation, cyclosporine, and mycophenolate mofetil in treating older patients who have acute myeloid leukemia.

Primary objective: * Determine whether allogeneic peripheral blood stem cell transplantation with pre-conditioning low dose total body irradiation and fludarabine followed by cyclosporine and mycophenolate mofetil, when given to elderly patients with acute myeloid leukemia in first complete remission, is sufficiently efficacious (in terms of survival 1 year after transplantation) to warrant a phase III investigation. Secondary objective: * Determine the frequency and severity of toxic effects of this regimen in these patients. Other objectives as funding permits: * Determine whether chimerism patterns in bone marrow and blood after transplantation are associated with relapse and/or graft-versus-host disease (GVHD) in these patients. * Determine whether cytogenic, immunophenotypic, and molecular biologic features detected in pre- and post-transplantation specimens are related to transplant outcomes and risk of relapse in these patients. OUTLINE: This is an open-label study. * Conditioning regimen: Patients receive fludarabine IV over 1 hour on days -4 to -2. Patients also undergo total body irradiation on day 0. * Peripheral blood stem cell infusion (PBSC): Patients receive unmodified filgrastim transplantation (G-CSF)-mobilized donor PBSC on day 0. * Post-transplantation immunosuppression: Patients receive oral cyclosporine on days -3 to 35 followed by a taper until day 180. Patients also receive oral mycophenolate mofetil on day 0 to 27 without tapering. * Donor lymphocyte infusions (DLI): Patients with relapsed disease receive DLI IV over 30 minutes for up to 2 infusions. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years. PROJECTED ACCRUAL: A total of 25-51 patients will be accrued for this study.

Leukemia

adult acute myeloid leukemia in remission adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with 11q23 (MLL) abnormalities

null

1

arm 1: patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - cyclosporine 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); mycophenolate mofetil 15mg/kg bid PO D0 to +27

[ 0 ]

6

[ 2, 0, 0, 0, 3, 4 ]

intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

intervention 1: therapeutic allogeneic lymphocytes intervention 2: cyclosporine intervention 3: fludarabine intervention 4: mycophenolate mofetil intervention 5: peripheral blood stem cell transplantation intervention 6: radiation therapy

83

0

NCT00053014

[ 3 ]

449

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease.

The purpose of this study is to evaluate the safety and efficacy of three different doses of belimumab (1 mg/kg, 4 mg/kg, and 10 mg/kg), administered in addition to standard therapy, compared to placebo plus standard therapy in patients with active SLE disease. Patients were randomly assigned, following stratification by the screening SELENA SLEDAI score (4 to 7 versus ≥ 8), to 1 of the 4 study arms (3 active arms and 1 placebo arm plus standard therapy for SLE). All patients were to be dosed on Days 0, 14, and 28, then every 28 days for the remainder of 52 weeks. Patients completing the 52-week period could enter a 24-week open-label extension; belimumab patients received the same dose or were switched to 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg.

Lupus Erythematosus, Systemic

SLE

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 IV plus standard therapy (SOC) for SLE; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, placebo patients who opted to participate received belimumab 10 mg/kg IV plus SOC every 28 days for an additional 24 weeks. intervention 2: Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks. intervention 3: Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 4 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks. intervention 4: Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate continued on belimumab 10 mg/kg for an additional 24 weeks.

intervention 1: Placebo intervention 2: Belimumab 1 mg/kg intervention 3: Belimumab 4 mg/kg intervention 4: Belimumab 10 mg/kg

62

0

NCT00071487

[ 4 ]

862

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

Study 0017 compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.

null

Staphylococcal Skin Infection

staph MRSA cSSSI

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Telavancin 10 mg/kg/day, IV for up to 14 days. intervention 2: Vancomycin 1 Gm IV q 12 hrs for up to 14 days.

intervention 1: Telavancin intervention 2: Vancomycin

1

National City | California | United States | -117.0992 | 32.67811

0

NCT00091819

[ 5 ]

36

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

false

0ALL

false

The purpose of this study is to compare the vascular effects of two commonly used blood pressure medications, carvedilol and metoprolol in hypertensive patients with type 2 diabetes.

Carvedilol and metoprolol are two commonly used blood pressure medications that have both been shown to be effective in controlling hypertension. Although in the same drug class, preliminary data have shown that these medications may have different vascular effects. This study will assess which medication is better at improving artery health independent of their blood pressure lowering effects. Artery health will be assessed non-invasively by ultrasound. Certain markers of atherosclerosis found in the blood will also be measured.

Hypertension Type 2 Diabetes Mellitus

beta-blockers endothelial function

null

2

arm 1: Carvedilol, orally, 25 mg, twice daily for five months arm 2: Metoprolol, orally, 200 mg, twice daily for five months.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 25 mg twice daily for five months. intervention 2: 200 mg twice daily for five months.

intervention 1: Carvedilol intervention 2: Metoprolol

1

Saint Paul | Minnesota | United States | -93.09327 | 44.94441

0

NCT00123604

[ 3 ]

264

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The study's objective is to compare the efficacy of 3 dose levels of oral CP-690,550 monotherapy (5 mg, 15 mg, and 30 mg twice daily \[BID\]) versus placebo administered over 6 weeks for the treatment of the signs and symptoms of subjects with active rheumatoid arthritis (RA).

null

Rheumatoid Arthritis

oral JAK inhibitor clinical trial joint diseases anti-Inflammatory agents rheumatic diseases DMARD Antirheumatic Agents Autoimmune Diseases Immune System Diseases

null

4

arm 1: CP 690,550 5 mg BID arm 2: CP 690,550 15 mg BID arm 3: Oral tablets administered at a dose of 30 mg BID for 6 weeks arm 4: Placebo

[ 0, 0, 0, 2 ]

4

[ 0, 0, 0, 10 ]

intervention 1: Oral tablets administered at a dose of 5 mg BID for 6 weeks intervention 2: Oral tablets administered at a dose of 15 mg BID for 6 weeks intervention 3: 30 mg BID for 6 weeks intervention 4: Placebo tablets

intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: Placebo

60

0

NCT00147498

[ 3 ]

206

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This was a 22-week, prospective, randomized, double-blind, placebo-controlled, multicenter, parallel-group study that included a 4-week Baseline Phase at the beginning and a 4-week single-blind placebo Safety Phase at the end of the study.

null

Migraine Prophylaxis

null

2

arm 1: During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase). arm 2: During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).

[ 2, 0 ]

2

[ 0, 10 ]

intervention 1: None intervention 2: None

intervention 1: E2007 intervention 2: Placebo

9

0

NCT00154063

[ 5 ]

62

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

Comparison of clinical efficacy and safety of levocetirizine in PER continuous versus on demand, measured by evolution of individual symptom scores during 6 months.

null

Rhinitis, Allergic, Perennial

Persistent Allergic Rhinitis HDM Parietaria sneezing rhinorrhea ocular pruritus Rhinasthma inflammatory cells ICAM-1 ATAREAL Xyzal Levocetirizine

null

2

arm 1: 5 mg of Levocetirizine (LCTZ) was taken orally once a day. arm 2: 5 mg of Levocetirizine (LCTZ) was taken whenever needed.

[ 0, 0 ]

1

[ 0 ]

intervention 1: * Pharmaceutical form: Tablet * Concentration: 5 mg * Route of administration: Oral use

intervention 1: Levocetirizine

1

Genova | N/A | Italy | 11.87211 | 45.21604

0

NCT00160680

[ 0 ]

45

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

Subjects are scheduled to undergo a Greater Occipital Nerve Block (GONB) as treatment for your chronic daily headache (CDH). GONB has been used for many years in the treatment of headaches. The nerve block is done by injecting a liquid drug through the skin of the back of the head to the area of the greater occipital nerve. The nerve runs superficially in this area, therefore the drugs are injected just under the skin. The injected drugs block electrical transmission through the nerve, resulting in reduced head pain. There are treatment options for patients receiving a GONB, however, some clinicians use local anesthetics (lidocaine and /or bupivicaine) alone, and some use local anesthetics with local steroid injection. The purpose of this study is to evaluate whether or not there is an observed difference between these two treatment approaches for GONB. We expect to enroll 60 patients into this research study at Thomas Jefferson University only.

null

Migraine

null

2

arm 1: Adult patients with CDH, and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and trigger point injections in the cervical paraspinal and the trapezius muscles bilaterally. arm 2: Adult patients with CDH, and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and trigger point injections in the cervical paraspinal and the trapezius muscles bilaterally.

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: lidocaine, bupivicaine and saline-2 cc were injected to each GON and 0.5 cc to each trigger point. Total injected volume = 10 cc. intervention 2: lidocaine, bupivicaine and triamcinolone (steroid)-2 cc were injected to each GON and 0.5 cc to each trigger point. Total injected volume = 10 cc.

intervention 1: lidocaine, bupivicaine and saline intervention 2: lidocaine plus bupivicaine plus triamcinolone (steroid)

1

Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238

0

NCT00203294

[ 0 ]

3

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

null

Olanzapine (o-lan-zah-peen) is a medication that has been approved by the Food and Drug Administration (FDA) for the treatment of patients with schizophrenia and/ or bipolar disorder. The trade name for this drug is Zyprexa®. Olanzapine has not been approved by the FDA for the prevention of migraine and is experimental for the purposes of this research study. The Jefferson Headache Center at Thomas Jefferson University has developed this clinical study to evaluate the safety and effectiveness of Olanzapine in preventing migraine headaches.

null

Migraine

null

2

arm 1: Olazepam arm 2: None

[ 5, 5 ]

2

[ 0, 0 ]

intervention 1: Olanzapine (5-10 mg) daily during first intervention period, then placebo(matching)druing second intervention period (after a washout period) intervention 2: Placebo (matching) during first intervention period, then olanzapine (5-10 mg. daily) during the second intervention period (after a washout phase).

intervention 1: Olanzapine during first intervention period and placebo during second intervention period intervention 2: Placebo during first intervention period, then olanzapine during second intervention period

1

Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238

0

NCT00203307

[ 4 ]

117

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The intent of this study is to demonstrate the efficacy and safety of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in newly or previously diagnosed CIDP subjects. Eight courses of treatment with either placebo or IGIV-C will occur every 3 weeks. Neurological function will be measured by Inflammatory Neuropathy Cause and Treatment (INCAT) scores. Patients who deteriorate or show no improvement between day 16 and month 6 will receive the alternate study drug for an additional 6 months.

110 subjects, 55 per treatment group, with newly or previously diagnosed CIDP defined by INCAT neurophysiological diagnostic criteria will be enrolled into the trial. Patients will not be replaced if they discontinue prematurely.

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Immunoglobulin G

null

2

arm 1: IGIV-C arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 2 g/kg body weight ideally over 2-4 days . Thereafter, study drug infusion (IGIV-C) will be administered every 3 weeks at a dose of 1 g/kg bw, given over 1-2 days for a total of 7 additional infusions intervention 2: Albumin 25%, USP diluted with dextrose 5% to a final concentration of 0.1% as an intravenous infusion. Alternatively, it may be a bottled placebo of 0.1% Albumin (Human) in 0.2 M Glycine, 1.1 mm sodium caprylate, 0.25% sodium chloride. 2 g/kg body weight ideally over 2-4 days . Thereafter, infusion (placebo) will be administered every 3 weeks at a dose of 1 g/kg bw, given over 1-2 days for a total of 7 additional infusions

intervention 1: Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified intervention 2: Albumin (Human) 25%, United States Pharmacopeia (USP)

32

New Haven | Connecticut | United States | -72.92816 | 41.30815 St Louis | Missouri | United States | -90.19789 | 38.62727 New York | New York | United States | -74.00597 | 40.71427 Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 Cleveland | Ohio | United States | -81.69541 | 41.4995 Dallas | Texas | United States | -96.80667 | 32.78306 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Capital Federal | N/A | Argentina | N/A | N/A Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Brno | N/A | Czechia | 16.60796 | 49.19522 Ostrava-Poruba | N/A | Czechia | N/A | N/A Pardubice | N/A | Czechia | 15.77659 | 50.04075 Prague | N/A | Czechia | 14.42076 | 50.08804 Berlin | N/A | Germany | 13.41053 | 52.52437 Tel Aviv | N/A | Israel | 34.78057 | 32.08088 Tel Litwinsky | N/A | Israel | 34.84588 | 32.05096 Zrifin | N/A | Israel | N/A | N/A Chieti | N/A | Italy | 14.16494 | 42.34827 Genova | N/A | Italy | 11.87211 | 45.21604 Milan | N/A | Italy | 12.59836 | 42.78235 Guadalajara | Jalisco | Mexico | -103.34749 | 20.67738 Guadalajara | Jalisco | Mexico | -103.34749 | 20.67738 San Luis Potosí City | N/A | Mexico | -100.97135 | 22.15234 Gdansk | N/A | Poland | 18.64912 | 54.35227 Krakow | N/A | Poland | 19.93658 | 50.06143 Lodz | N/A | Poland | 19.47395 | 51.77058 Lubin | N/A | Poland | 16.20149 | 51.40089 Warsaw | N/A | Poland | 21.01178 | 52.22977 Zgierz | N/A | Poland | 19.40623 | 51.85561 Belgrade | N/A | Serbia | 20.46513 | 44.80401

0

NCT00220740

[ 3 ]

82

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The objective of this trial is to evaluate safety and efficacy of rotigotine nasal spray (SPM 952) in a single dose application scheme. Subjects will undergo a 2 - 28 days screening period in which eligibility criteria will be checked. Subjects will then be hospitalized for one night. In the morning of the next day, subjects will be randomly assigned either to rotigotine or placebo nasal spray and will then receive a single dose of trial medication. Safety assessments after application include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks. Efficacy will be assessed by application of motor examination scores. The first subject is planned to be enrolled in February 2006. The last subject is planned to be enrolled in May 2006. Last subject out is expected for August 2006.

The objective of this trial is to evaluate safety and efficacy of rotigotine nasal spray (SPM 952)in a single dose application scheme. Subjects will undergo a 2-28 days screening period in which eligibility criteria will be checked. Subjects will then be hospitalized for one night. In the morning of the next day, subjects will be randomly assigned either to rotigotine or placebo nasal spray and will then receive a single dose of trial medication. Safety assessments after application include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks. Efficacy will be assessed by application of motor examination scores.

Parkinson's Disease

Rotigotine Rotigotine nasal spray Efficacy, safety and tolerability Parkinson's disease

null

5

arm 1: Placebo nasal spray 1 - 4 puffs arm 2: Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine) arm 3: Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine) arm 4: Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine) arm 5: Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)

[ 2, 0, 0, 0, 0 ]

2

[ 0, 10 ]

intervention 1: Rotigotine- HCl 2.5mg/mL nasal spray, dosage per puff of 275µg per 110µg administered in up to 4 deliveries intervention 2: placebo nasal spray 1, 2 3, and 4 puffs

intervention 1: Rotigotine nasal spray intervention 2: Placebo

0

null

0

NCT00296192

[ 3 ]

49

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This study evaluates the safety and efficacy of plerixafor given in addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells (PBSCs) for autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM). Efficacy outcomes include evaluation of fold increase in circulating CD34+ cells from just before the first plerixafor injection to 10-11 hours post plerixafor (just before apheresis) and assessment of successful polymorphonuclear leukocyte (PMN) engraftment after transplantation. Data from this protocol will assist in the determination of the dosing schedule for future studies.

Participants with NHL and MM who have undergone prior cyto-reductive chemotherapy, are to be autologously transplanted, and meet the inclusion/exclusion criteria are eligible to enter the study. The only change to the standard of care is the addition of plerixafor to a granulocyte colony-stimulating factor (G-CSF) mobilization regimen on the day prior to apheresis. Participants will undergo mobilization with G-CSF (10 mcg/kg each day) and will receive plerixafor (240 mcg/kg) in the evening prior to apheresis. Participants will undergo apheresis for up to 5 consecutive days in order to collect the target number of CD34+ stem cells (≥ 5\*10\^6 CD34+ cells/kg for either single or tandem transplant). After apheresis, all participants will be treated with high-dose chemotherapy in preparation for transplantation. Participants will be transplanted with cells obtained from the G-CSF and plerixafor mobilization regimen. The increase in CD34+ cells in the peripheral blood from the time of the plerixafor dose to just prior to apheresis and the number of CD34+ cells in the apheresis product will be measured. The number of apheresis sessions required to obtain ≥ 5\*10\^6 CD34+ cells will also be measured. Success of the transplantation(s) will be evaluated by the time to engraftment of polymorphonuclear leukocytes (PMN) and platelets (PLT). Participants will be followed for durability of their transplant for 12 months following transplantation. This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Lymphoma, Non-Hodgkin Multiple Myeloma

Non-Hodgkin's Lymphoma Multiple Myeloma Stem cell mobilization

null

2

arm 1: Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected. arm 2: Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.

[ 0, 0 ]

1

[ 0 ]

intervention 1: Participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection each morning. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.

intervention 1: G-CSF Plus Plerixafor

8

0

NCT00322491

[ 4 ]

456

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

null

This study compares of the safety and efficacy of intravenous iron vs oral iron in the treatment of anemia secondary to heavy uterine bleeding

This is an open-label, randomized, Phase III, active-control, study of the efficacy and safety of IV iron vs oral iron in patients with anemia secondary to heavy uterine bleeding.

Anemia

anemia heavy uterine bleeding menorrhagia Anemia secondary to heavy uterine bleeding

null

2

arm 1: Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered arm 2: 325 mg tablets TID on Days 0 through Day 42

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered intervention 2: 325 mg tablets TID on Days 0 through Day 42

intervention 1: Ferric Carboxymaltose (FCM) intervention 2: Ferrous Sulfate tablets

1

Norristown | Pennsylvania | United States | -75.3399 | 40.1215

0

NCT00395993