phases list | enrollmentCount int64 | allocation string | interventionModel string | primaryPurpose class label | masking class label | healthyVolunteers bool | sex class label | oversightHasDmc bool | briefSummary string | detailedDescription string | conditions string | conditionsKeywords string | protocolPdfText string | numArms int64 | armDescriptions string | armGroupTypes list | numInterventions int64 | interventionTypes list | interventionDescriptions string | interventionNames string | numLocations int64 | locationDetails string | target int64 | nctid string |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
2
] | 80 | RANDOMIZED | CROSSOVER | 9OTHER | 0NONE | true | 0ALL | false | The objective of this study is to compare the rate and extent of absorption of losartan 100 mg tablets (test) versus Cozaar® (reference), administered as 1 \* 100 mg tablet under fed conditions. | Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA Bioequivalence Statistical Methods | Healthy | Bioequivalence Healthy Subjects | null | 2 | arm 1: Losartan 100 mg Tablets arm 2: Cozaar® 100 mg Tablets | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 100 mg Tablets intervention 2: 100 mg Tablets | intervention 1: Losartan intervention 2: Cozaar® | 1 | Sainte-Foy | Quebec | Canada | -71.29217 | 46.78139 | 0 | NCT01124175 |
[
5
] | 188 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | This study will compare mometasone nasal spray to placebo in treating the nasal and asthma symptoms experienced by participants with seasonal allergic rhinitis (SAR) and concomitant asthma. | null | Rhinitis, Allergic, Seasonal Asthma | Seasonal Allergic Rhinitis Asthma | null | 2 | arm 1: Mometasone nasal spray 200 mcg, administered once daily (QD) for 4 weeks arm 2: Matching placebo nasal spray, administered QD for 4 weeks | [
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Mometasone nasal spray 200 mcg/day administered as 2 sprays (50 mcg/spray) in each nostril. intervention 2: Matching placebo nasal spray, administered QD as 2 sprays in each nostril. intervention 3: Albuterol/salbutamol metered dose inhaler (90 mcg/puff) used as needed as asthma rescue medication. | intervention 1: Mometasone intervention 2: Placebo intervention 3: Albuterol/Salbutamol | 0 | null | 0 | NCT00070707 |
[
3
] | 206 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the Central Nervous System (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the... | null | Multiple Sclerosis | Walking Ability Muscle strength Spasticity | null | 4 | arm 1: Placebo control, twice a day (b.i.d.) arm 2: 10 milligram (mg) fampridine b.i.d. arm 3: 15 mg fampridine b.i.d. arm 4: 20 mg fampridine b.i.d. | [
2,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Placebo for 15 weeks intervention 2: 2 week up titration (10 mg)
12 weeks stable dose (10 mg)
1 week down titration (10 mg) intervention 3: 10 mg twice daily for 1 week
15 mg twice daily for 14 weeks
2 week up titration (10 mg x 1 week, 15 mg x 1 week)
12 weeks stable dose (15 mg)
1 week down titr... | intervention 1: Placebo intervention 2: 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP) intervention 3: 15 mg fampridine-SR (4-aminopyridine, 4-AP) intervention 4: 20 mg fampridine-SR (4-aminopyridine, 4-AP) | 25 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Los Angeles | California | United States | -118.24368 | 34.05223
New Haven | Connecticut | United States | -72.92816 | 41.30815
Atlanta | Georgia | United States | -84.38798 | 33.749
Chicago | Illinois | United States | -87.65005 | 41.85003
Baltimore | Maryland ... | 0 | NCT00053417 |
[
0
] | 572 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 1FEMALE | false | The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg(Test Product) and Terconazole Vaginal Suppositories, 80 mg(Reference Product) in the treatment of subjects with vulvovaginal candidiasis in order to establish bioequivalence. | null | Vulvovaginal Candidiasis | Vulvovaginal Candidiasis Terconazole | null | 2 | arm 1: Terconazole Vaginal Suppository arm 2: Terazol Vaginal Suppository | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days intervention 2: Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days | intervention 1: Terconazole Vaginal Suppository intervention 2: Terazol Vaginal Suppository | 0 | null | 0 | NCT00803738 |
[
2
] | 12 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 0ALL | false | To investigate the steady-state pharmacokinetics of once-daily and twice-daily regimens of BIA 2-093 and twice-daily regimen of Oxcarbazepine (Trileptal®) in healthy subjects and to assess the tolerability of such regimens in healthy subjects. | Single centre, open-label, randomised, three-way crossover study in 12 healthy volunteers. The study consisted of three 8-day treatment periods separated by washout periods of 10-15 days. On each of the treatment periods the volunteers received either a daily oral dose of BIA 2-093 900 mg once-daily (od), BIA 2-093 450... | Epilepsy | Epilepsy Oxcarbazepine Eslicarbazepine Acetate BIA 2-093 | null | 3 | arm 1: BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period
BIA 2-093 450 mg od - BIA 2-093 450 mg bid - OXC 900 mg bid arm 2: BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 ... | [
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: BIA 2-093 intervention 2: Oxcarbazepine | 1 | S. Mamede Do Coronado | Trofa | Portugal | N/A | N/A | 0 | NCT01679002 |
[
3
] | 905 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate the effects of a drug known as CS-747 (also known as prasugrel) on subjects having a procedure called a percutaneous coronary intervention (also referred to as PCI) in which a doctor will attempt to open a blocked vessel (or vessels) in the heart using a catheter (a long thin tu... | null | Cardiovascular Diseases Heart Diseases | null | 4 | arm 1: Prasugrel (CS-747) 40 mg oral loading dose (LD) at time of percutaneous coronary intervention (PCI) followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days arm 2: Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 d... | [
0,
0,
0,
1
] | 2 | [
0,
0
] | intervention 1: Administered orally intervention 2: Administered orally | intervention 1: Prasugrel (CS-747) intervention 2: Clopidogrel | 2 | Boston | Massachusetts | United States | -71.05977 | 42.35843
Victoria | British Columbia | Canada | -123.35155 | 48.4359 | 0 | NCT00059215 | |
[
3
] | 169 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. One of the ways to deal with this problem is to develop new drugs that can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control infections and whether this drug can be safely... | null | Infections, Gram-Positive Bacterial Abscess Burns Cellulitis Ulcer Wound Infections | null | 2 | arm 1: None arm 2: cSSSI - complicated skin and skin structure infections | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Telavancin 7.5 mg/kg/day IV (intravenously) for up to 14 days intervention 2: Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days. | intervention 1: Telavancin intervention 2: Vancomycin or antistaphylococcal penicillin | 1 | Chula Vista | California | United States | -117.0842 | 32.64005 | 0 | NCT00061633 | |
[
3
] | 61 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to see whether the combination of a muscle relaxant and anti-inflammatory drug is more effective at relieving pain in patients with neck strains or whiplash than either of the two medications alone. | Muscle relaxants have been used extensively for neck and back pain since muscle spasm is thought to play a role in the cycle of pain and spasm. However, prior studies have conflicting results regarding their additive effect when given in addition to analgesics such as the NSAIDs. Because they have the potential to lead... | Cervical Strain | Cervical strain whiplash ibuprofen cyclobenzaprine | null | 3 | arm 1: None arm 2: None arm 3: None | [
1,
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: 5 mg orally every 8 hours as needed intervention 2: Ibuprofen 400 mg every 8 hours as needed intervention 3: Ibuprofen 400 mg plus cyclobenzaprine 5 mg every 8 hours as needed | intervention 1: Cyclobenzaprine intervention 2: Ibuprofen intervention 3: Ibuprofen plus Cyclobenzaprine | 1 | Stony Brook | New York | United States | -73.14094 | 40.92565 | 0 | NCT00790270 |
[
2
] | 244 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 0ALL | false | This study will evaluate the bioequivalence of alendronate in combination with vitamin D (cholecalciferol) compared to alendronate alone and the bioequivalence of vitamin D in combination with alendronate compared to vitamin D alone. | null | Osteoporosis | null | 4 | arm 1: alendronate/vitamin D combination then alendronate arm 2: alendronate then alendronate/vitamin D combination arm 3: alendronate/vitamin D combination then vitamin D arm 4: vitamin D then alendronate/vitamin D combination | [
0,
0,
0,
0
] | 3 | [
0,
0,
7
] | intervention 1: A single dose tablet of 70 mg alendronate/2800 IU (international unit) vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period. intervention 2: A single dose table of 70 mg alendronate in one treatment period of each sequence. There will be a 12 ... | intervention 1: alendronate sodium (+) cholecalciferol intervention 2: Comparator: alendronate intervention 3: Comparator: cholecalciferol (Vitamin D) | 0 | null | 0 | NCT00806416 | |
[
2
] | 12 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 0ALL | false | This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a U.S. and non-U.S. marketed formulation of ondansetron. | null | Chemotherapy-Induced Nausea and Vomiting | null | 6 | arm 1: Treatment Sequence A-B-C arm 2: Treatment Sequence B-C-A arm 3: Treatment Sequence C-A-B arm 4: Treatment Sequence A-C-B arm 5: Treatment Sequence B-A-C arm 6: Treatment Sequence C-B-A | [
0,
0,
0,
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO) intervention 2: a single 8 mg tablet of Zofran marketed in the U.K., taken PO intervention 3: a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO | intervention 1: Comparator: Treatment A (Zofran, ondansetron) intervention 2: Comparator: Treatment B (Zofran, ondansetron) intervention 3: Comparator: Treatment C (Zofran, ondansetron) | 0 | null | 0 | NCT00971633 | |
[
2
] | 50 | RANDOMIZED | CROSSOVER | null | 0NONE | true | 0ALL | null | The object of this study is to compare the relative bioavailability of lansoprazole 30 mg delayed-release capsules (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of PREVACID® capsules (TAP Pharmaceuticals, Inc.) in healthy, adult, subjects under fasting cond... | Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA Bioequivalence Statistical Methods | Healthy | Bioequivalence Healthy Subjects | null | 2 | arm 1: Lansoprazole 30 mg Delayed-Release Capsule arm 2: Prevacid® 30 mg Delayed-Release Capsule | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 30 mg Delayed-Release Capsules intervention 2: 30 mg Delayed-Release Capsule | intervention 1: Lansoprazole intervention 2: Prevacid® | 1 | Saint Charles | Missouri | United States | -90.48123 | 38.78394 | 0 | NCT01046253 |
[
4
] | 204 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with spinal cord injury, some fibers may be destroyed at the site of injury, while others remain connected but do not work correctly to carry electrical impulses. As a res... | null | Spinal Cord Injury Muscle Spasticity | spinal cord injury muscle spasticity | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 25mg bid (twice daily) intervention 2: Placebo | intervention 1: Fampridine-SR intervention 2: Placebo | 30 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Long Beach | California | United States | -118.18923 | 33.76696
Sacramento | California | United States | -121.4944 | 38.58157
San Jose | California | United States | -121.89496 | 37.33939
Englewood | Colorado | United States | -104.98776 | 39.64777
New Britai... | 1 | NCT01683838 |
[
3
] | 395 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | Matrix metalloproteinases (MMPs) have been implicated in the cartilage degradation. PG-530742 inhibits some MMPs, potentially limiting cartilage degradation and disease progression. This study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate knee osteoarthritis. | Matrix metalloproteinases have been implicated in the cartilage degradation that occurs in osteoarthritis. PG-530742 inhibits some of these matrix metalloproteinases, thus potentially limiting cartilage degradation and disease progression. This study will test the efficacy and safety of PG-530742 in the treatment of mi... | Osteoarthritis, Knee | Primary Disease: Knee Primary Osteoarthritis | null | 5 | arm 1: Placebo tablet arm 2: 25 mg PG-530742 arm 3: 50 mg PG-530742 arm 4: 100 mg PG-530742 arm 5: 200 mg PG-530742 | [
2,
0,
0,
0,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: One 25 mg PG-530742 tablet, twice daily for for one year intervention 2: One placebo tablet, twice daily for for one year intervention 3: One 50 mg PG-530742 tablet, twice daily for for one year intervention 4: 100 mg PG-530742 tablet, twice a day for one year intervention 5: 200 mg PG-530742 tablet, tw... | intervention 1: PG-530742 intervention 2: Placebo intervention 3: 50 mg PG-530742 intervention 4: 100 mg PG-530742 intervention 5: 200 mg PG-530742 | 23 | Visegrád | Gizella Telep | Hungary | 18.9709 | 47.78526
Győr | Hid Utica 2 | Hungary | 17.63512 | 47.68333
Budapest | N/A | Hungary | 19.04045 | 47.49835
Budapest | N/A | Hungary | 19.04045 | 47.49835
Budapest | N/A | Hungary | 19.04045 | 47.49835
Budapest | N/A | Hungary | 19.04045 | 47.49835
Miskolc | N/A | Hungary |... | 0 | NCT00041756 |
[
4
] | 760 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to evaluate the safety and efficacy of febuxostat, once daily (QD), versus allopurinol in subjects with gout. | This was a randomized, controlled, double-blind study of 52 weeks duration. Subjects receiving prior urate-lowering therapy underwent a 2-week washout period prior to randomization. Subjects were then randomized to one of three treatment groups: febuxostat 80 milligram (mg), febuxostat 120 mg, or allopurinol 300 mg. Na... | Gout | uric Acid xanthine oxidase tophi Drug Therapy | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Febuxostat 80 mg, orally, once daily for up to 52 weeks. intervention 2: Febuxostat 120 mg, orally, once daily for up to 52 weeks. intervention 3: Allopurinol 300 mg, capsules, orally, once daily for up to 52 weeks. | intervention 1: Febuxostat intervention 2: Febuxostat intervention 3: Allopurinol | 0 | null | 0 | NCT00102440 |
[
2
] | 20 | RANDOMIZED | CROSSOVER | null | 0NONE | true | 0ALL | false | The object of this study was to compare the relative bioavailability (rate and extent of absorption) of 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets manufactured by Teva Pharmaceutical Industries Ltd. and distributed by Teva Pharmaceuticals USA with that of Hyzaar® 100/25 mg Tablets distributed by Merck \& ... | Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA Bioequivalence Statistical Methods | Healthy | Bioequivalence Healthy Subjects | null | 2 | arm 1: Losartan potassium/Hydrochlorothiazide 100/25 mg Tablets arm 2: Hyzaar® 100/25 mg Tablets | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 100/25 mg Tablets intervention 2: 100/25 mg Tablets | intervention 1: Losartan potassium/Hydrochlorothiazide intervention 2: Hyzaar® | 1 | Fargo | North Dakota | United States | -96.7898 | 46.87719 | 0 | NCT01149486 |
[
3
] | 6 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The primary objective of this study is to evaluate the safety and tolerability of 4 doses of lomitapide (AEGR-733; BMS-201038) given as an initial low dose and then escalated through an additional 3 dose levels over a 16-week period.
The secondary objectives of this study included the evaluation of the pharmacodynamic... | This is a single center, open-label, Phase 2 clinical trial designed to evaluate the safety, tolerability, and pharmacodynamics of lomitapide in the treatment of patients with homozygous familial hypercholesterolemia (HoFH).
Patients are required to stop all lipid-lowering therapies, including apheresis, within 4 week... | Homozygous Familial Hypercholesterolemia | null | 1 | arm 1: This is an open label trial where all patients receive lomitapide (AEGR733/BMS-201038)at escalating doses | [
0
] | 1 | [
0
] | intervention 1: Oral administration with escalating doses administered once daily | intervention 1: Lomitapide | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT01556906 | |
[
3
] | 3 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Current therapies for adults with meningioma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with meningioma.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antin... | OBJECTIVES:
* To determine the efficacy of Antineoplaston therapy in adults with meningima as measured by an objective response to therapy (complete response, partial response) or stable disease.
* To determine the safety and tolerance of Antineoplaston therapy in adults with meningima.
OVERVIEW: This is a single arm... | Meningioma | adult meningioma recurrent adult meningioma | null | 1 | arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. | [
0
] | 1 | [
0
] | intervention 1: Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal). | intervention 1: Antineoplaston therapy (Atengenal + Astugenal) | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00003483 |
[
4
] | 39 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of the study is to evaluate the ability of rhASB versus placebo to enhance endurance in patients with Mucopolysaccharidosis VI (MPS VI), as evidenced by an increase in the number of meters walked in the 12 minute walk test at Week 24 compared with baseline. | null | Mucopolysaccharidosis VI | null | 2 | arm 1: None arm 2: None | [
2,
1
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Placebo intervention 2: N-acetylgalactosamine 4-sulfatase | 1 | Novato | California | United States | -122.5697 | 38.10742 | 0 | NCT00067470 | |
[
4
] | 177 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine whether Sativex® and GW-2000-02 are effective in the management of subjects with intractable cancer-related pain. | This is a two week (two days baseline and two weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex® and GW-2000-02 in subjects with cancer-related pain. Subjects are screened to determine eligibility and completed a two-day baseline... | Palliative Care Pain Cancer | Palliative Care Pain Cancer | null | 3 | arm 1: Placebo control arm 2: Active treatment arm 3: Active treatment | [
2,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Containing colourants and excipients. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations in 24 hours. intervention 2: Containing D9 tetrahydrocannabinol (THC), 27 mg/m... | intervention 1: Placebo intervention 2: Sativex® intervention 3: THC Alone | 1 | Shrewsbury | N/A | United Kingdom | -2.75208 | 52.71009 | 0 | NCT00674609 |
[
2
] | 32 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a single oral dose administered under fasting conditions. | The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a single oral dose administered under fasting conditions. Thirty-two non-smoking, non-obese, healthy male and female volunteers betwee... | Therapeutic Equivalency | null | 2 | arm 1: A single dose of cilostazol (1 x 100 mg tablet) administered after an overnight fast of at least 10 hours. arm 2: A single dose of cilostazol (Pletal® 1 x 100 mg tablet) administered after an overnight fast of at least 10 hours. | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Cilostazol (1 x 100 mg tablet) administered after an overnight fast of at least 10 hours intervention 2: Cilostazol (Pletal® 1 x 100mg tablet) administered after an overnight fast of at least 10 hours. | intervention 1: Cilostazol 100 mg Tablets intervention 2: Cilostazol (Pletal®) 100 mg Tablets | 0 | null | 0 | NCT00684762 | |
[
4
] | 189 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy, safety and tolerability of Sativex® in subjects diagnosed with MS and spasticity. | This was an eight week (two weeks baseline, six weeks treatment), multicentre, double blind, randomised, placebo controlled parallel group study to evaluate the efficacy, safety and tolerability of Sativex® in subjects diagnosed with MS and spasticity. Subjects were screened to determine eligibility and completed a two... | Spasticity Multiple Sclerosis | Spasticity Multiple Sclerosis | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: containing THC (27 mg/ml):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: containing peppermint oil, 0.05% (v/... | intervention 1: Sativex® intervention 2: Placebo | 1 | Reading | Oxfordshire | United Kingdom | -0.97113 | 51.45625 | 0 | NCT00711646 |
[
4
] | 125 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in relieving peripheral neuropathic pain associated with allodynia. | This was a six week, multicentre, double blind, randomised, placebo controlled parallel group study to evaluate the efficacy of Sativex®. Subjects with peripheral neuropathic pain characterised by allodynia, were screened to determine eligibility and entered a seven day baseline period. Subjects then returned to the ce... | Pain Peripheral Neuropathy | Pain Peripheral Neuropathy | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: containing THC (27 mg/ml):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: containing peppermint oil, 0.05% (v/... | intervention 1: Sativex® intervention 2: Placebo | 1 | Fazakerley | Liverpool | United Kingdom | -2.92863 | 53.4614 | 0 | NCT00711880 |
[
2
] | 27 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 2DOUBLE | true | 0ALL | false | The purpose of this study is to evaluate and compare the relative bioavailability of Quinine Sulfate 324 mg capsules, manufactured by the Mutual Pharmaceutical Company, to Quinine Sulphate 300 mg tablets, manufactured by the Government Pharmaceutical Organization, Bangkok Metropolis, Thailand, after single oral dose ad... | The purpose of this study is to evaluate and compare the relative bioavailability of Quinine Sulfate 324 mg capsules, manufactured by the Mutual Pharmaceutical Company, to Quinine Sulphate 300 mg tablets, manufactured by the Government Pharmaceutical Organization, Bangkok Metropolis, Thailand, after single oral dose ad... | Healthy | Bioavailability | null | 3 | arm 1: A single dose of quinine sulfate 324 mg administered with 240 mL of room temperature water after an overnight fast of at least 10 hours. arm 2: A single dose of quinine sulphate 300 mg administered with 240 mL of room temperature water after an overnight fast of at least 10 hours. arm 3: A single dose of quinine... | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: One 324 mg capsule administered after an overnight fast of at least 10 hours. intervention 2: One 300 mg tablet administered after an overnight fast of at least 10 hours. intervention 3: One 324 mg capsule administered thirty minutes after the initiation of a standardized, high-fat breakfast. | intervention 1: Quinine Sulfate Capsules 324 mg intervention 2: Quinine Sulphate Tablets 300 mg intervention 3: Quinine Sulfate Capsules 324 mg | 1 | Fargo | North Dakota | United States | -96.7898 | 46.87719 | 0 | NCT00727272 |
[
2
] | 26 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 0ALL | null | The main purpose of this study is to compare the pharmacokinetic profile to establish the better controlled liberation of the test product (Tramadol HCL OAD tablets of 200 mg, Labopharm) and its bioavailability in relation with the commercialised reference (Zytram® tablets of 200 mg, Zambon), single dose administered. | null | Pain | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 1 Tramadol Contramid OAD 200 mg tablet as a single dose intervention 2: 1 Zytram 200 mg tablet as a single dose | intervention 1: Tramadol Contramid OAD intervention 2: Zytram | 0 | null | 0 | NCT00911742 | |
[
2
] | 24 | NON_RANDOMIZED | PARALLEL | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | A study to evaluate the pharmacokinetics of CP-690,550 in subjects with mild, moderate or severe renal impairment, who do not require hemodialysis, compared to healthy controls. | null | Renal Impairment | CP-690 550 pharmacokinetics renal impairment | null | 4 | arm 1: Healthy volunteers arm 2: patients with mild (\>50 and ≤80 mL/min) renal impairment arm 3: patients with moderate (≥30 and ≤50 mL/min) renal impairment arm 4: patients with severe (\<30 mL/min) renal impairment | [
5,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: 10 mg (2 x 5 mg tablets), single dose intervention 2: 10 mg (2 x 5 mg tablets), single dose intervention 3: 10 mg (2 x 5 mg tablets), single dose intervention 4: 10 mg (2 x 5 mg tablets), single dose | intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: CP-690,550 | 4 | Orlando | Florida | United States | -81.37924 | 28.53834
New Orleans | Louisiana | United States | -90.07507 | 29.95465
New Orleans | Louisiana | United States | -90.07507 | 29.95465
Minneapolis | Minnesota | United States | -93.26384 | 44.97997 | 0 | NCT01740362 |
[
2
] | 18 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 0ALL | false | Single centre, open-label, randomised, three-way crossover study in 18 healthy subjects (9 males and 9 females). The study consisted of three consecutive single-dose treatment periods separated by a washout period of 7 days or more. On each treatment period, the volunteers received a single dose of BIA 2-093 800 mg, or... | Sample size (planned and analyzed): It was planned to have at least 16 healthy subjects completed and evaluable. Taking into account the potential occurrence of dropouts, two additional subjects were to be recruited and entered the study. Therefore, a total of 18 subjects were enrolled.
Diagnosis and main selection cr... | Epilepsy | null | 3 | arm 1: 1. st period - 16 mL oral suspension 50 mg/mL
2. nd period - Four 200 mg tablets
3. rd period - One 800 mg tablet arm 2: 1. st period - One 800 mg tablet
2. nd period - 16 mL oral suspension 50 mg/mL
3. rd period - Four 200 mg tablets arm 3: 1. st period - Four 200 mg tablets
2. nd period - One 800 mg tablet
3. ... | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: oral suspension 50 mg/mL intervention 2: 200 mg tablet intervention 3: 800 mg tablet | intervention 1: BIA 2-093 intervention 2: BIA 2-093 intervention 3: BIA 2-093 | 1 | Azinhaga de Santa Comba - Celas | Coimbra District | Portugal | N/A | N/A | 0 | NCT02279667 | |
[
4
] | 1,987 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in combination with leucovorin, in patients who have undergone surgery for colon cancer. Patients will be randomized to receive either Xeloda 1250mg/m2 po bid on days 1-14 every 21 days, or leucovorin 20mg/m2 iv + 5-fluorouracil 425... | null | Colorectal Cancer | null | 2 | arm 1: Participants received capecitabine 1250 milligram per square meter (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks). arm 2: Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil... | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: 425mg/m2 iv daily from day 1 to day 5 every 28 days. intervention 2: 20mg/m2 iv daily from day 1 to day 5 every 28 days. intervention 3: 1250mg/m2 po bid on days 1-14 every 21 days. | intervention 1: 5-Fluorouracil intervention 2: Leucovorin intervention 3: Capecitabine [Xeloda] | 133 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Fountain Valley | California | United States | -117.95367 | 33.70918
Los Angeles | California | United States | -118.24368 | 34.05223
Hartford | Connecticut | United States | -72.68509 | 41.76371
Miami ... | 0 | NCT00009737 | |
[
4
] | 1,072 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD), in subjects with gout. | A Phase 3 Study comparing 80 mg, 120 mg or 240 mg of febuxostat, allopurinol (300 mg for those with normal renal function and 100 mg for those with impaired renal function) and placebo administered once daily in subjects with gout.
Subjects will receive treatment for 28 weeks. | Gout | Uric Acid, gout, xanthine oxidase, febuxostat, tophi | null | 5 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None | [
0,
0,
0,
1,
2
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Febuxostat 80 mg, orally, once daily for up to 28 weeks. intervention 2: Febuxostat 120 mg, orally, once daily for up to 28 weeks. intervention 3: Febuxostat 240 mg, orally, once daily for up to 28 weeks. intervention 4: Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received wa... | intervention 1: Febuxostat intervention 2: Febuxostat intervention 3: Febuxostat intervention 4: Allopurinol intervention 5: Placebo | 0 | null | 0 | NCT00174915 |
[
2
] | 14 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 0ALL | null | This study will determine definitive bioequivalence of the United States (U.S.) and United Kingdom (UK) formulations of fenofibrate following administration of single doses in healthy adult subjects. | null | Dyslipidemia | null | 2 | arm 1: Fenofibrate U.S. Formulation arm 2: Fenofibrate UK Formulation | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Single dose of 160 mg fenofibrate U.S. formulation (Tricor®) in one of two treatment periods. intervention 2: Single dose of 160 mg fenofibrate UK formulation (Supralip®) in one of two treatment periods. | intervention 1: fenofibrate (U.S. formulation) intervention 2: fenofibrate (UK formulation) | 0 | null | 0 | NCT00928694 | |
[
2
] | 80 | RANDOMIZED | CROSSOVER | 9OTHER | 0NONE | true | 0ALL | false | The objective of this study is to compare the relative bioavailability of Losartan potassium/Hydrochlorothiazide 100/25 mg tablets (manufactured by Teva Pharmaceutical Industries, Ltd. and distributed by Teva Pharmaceuticals USA) with that of Hyzaar® 100/25 mg tablets (Merck) in healthy, adult, non-smoking subjects und... | Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA Bioequivalence Statistical Methods | Healthy | Bioequivalence Healthy Subjects | null | 2 | arm 1: Losartan potassium/Hydrochlorothiazide 100/25 mg Tablets arm 2: Hyzaar® 100/25 mg Tablets | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 100/25 mg Tablets intervention 2: 100/25 mg Tablets | intervention 1: Losartan potassium/Hydrochlorothiazide intervention 2: Losartan potassium/Hydrochlorothiazide | 1 | Fargo | North Dakota | United States | -96.7898 | 46.87719 | 0 | NCT01149473 |
[
2
] | 59 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study was conducted in subjects with psoriasis to evaluate drug activity in this patient population by analysis of changes in psoriatic lesion biopsy characteristics. This subject population was selected to evaluate potentially relevant biological activity of CP-690,550 as well as assessing safety and pharmacokine... | null | Psoriasis Immunomodulation | Psoriasis PASI plaques skin biopsy immunomodulation | null | 6 | arm 1: 5 mg BID for 13 days and once on Day 14 arm 2: 10 mg BID for13 days and once on Day 14\* arm 3: 20 mg BID for 13 days and once on Day 14 arm 4: 30 mg BID for 13 days and once on Day 14 arm 5: 60 mg QD for 14 days arm 6: 50 mg BID x 13 days and once on day 14 | [
0,
0,
0,
0,
0,
0
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: 5 mg BID For 13 days and once on Day 14 intervention 2: 10 mg BID for 13 days and once on Day 14\* intervention 3: 20 mg BID for 13 days and once on Day 14 intervention 4: 30 mg BID for 13 days and once on Day 14 intervention 5: 60 mg tablet once a day (QD) for 14 days intervention 6: 50 mg tablets two ... | intervention 1: tofacitinib intervention 2: tofacitinib intervention 3: tofacitinib intervention 4: tofacitinib intervention 5: tofacitinib intervention 6: tofacitinib | 1 | Little Rock | Arkansas | United States | -92.28959 | 34.74648 | 0 | NCT01736696 |
[
3
] | 28 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 2MALE | false | Testosterone has traditionally been regarded as a risk factor for heart disease due to the fact that males have a higher incidence of this disease than women, at least until the menopause. However recent studies have shown that men with low levels of testosterone may be at an increased risk of developing coronary heart... | The main purpose of this project is to determine whether testosterone treatment over a number of weeks can beneficially affect myocardial perfusion, vascular reactivity, metabolic risk factors and quality of life in men with documented coronary heart disease. Men with documented significant coronary artery disease and ... | Coronary Heart Disease | null | 2 | arm 1: oral testosterone undecanoate, 80mg twice daily (Andriol Testocaps, Organon, The Netherlands) for 8 weeks arm 2: identical to active medication, taken in an identical way to the active arm | [
0,
2
] | 1 | [
0
] | intervention 1: Licensed for androgen deficiency | intervention 1: Testosterone undecanoate | 1 | London | N/A | United Kingdom | -0.12574 | 51.50853 | 0 | NCT00239590 | |
[
4
] | 213 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with spinal cord injury, some fibers may be destroyed at the site of injury, while others remain connected but do not work correctly to carry electrical impulses. As a res... | null | Spinal Cord Injury Muscle Spasticity | spinal cord injury muscle spasticity | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
10
] | intervention 1: 25mg bid (twice daily) intervention 2: Placebo | intervention 1: Fampridine-SR intervention 2: Placebo | 45 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Palo Alto | California | United States | -122.14302 | 37.44188
Pasadena | California | United States | -118.14452 | 34.14778
Wilmington | De... | 0 | NCT00041717 |
[
4
] | 1,992 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine the effect of an approved medication on the symptoms of perennial allergic rhinitis (an inflammation of the mucous membrane of the nose similar to that found in hay fever except that symptoms persist throughout the year), in patients who have a history of perennial allergic rhi... | null | Rhinitis, Allergic, Perennial | null | 2 | arm 1: Montelukast arm 2: Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: one 10 mg tablet, taken once daily at bed time for 6 weeks intervention 2: one placebo tablet, taken once daily at bed time for 6 weeks | intervention 1: Montelukast intervention 2: Comparator: Placebo | 0 | null | 0 | NCT00092118 | |
[
2
] | 38 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available Ambien® (zolpidem tartrate tablets)in adult subjects under fed conditions. | The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available Ambien® (zolpidem tartrate tablets)in adult subjects under fed conditions.
Thirty-eight healthy, non-smoking, non-obese male and female volunteers at le... | Healthy Therapeutic Equivalency | null | 2 | arm 1: A single dose of zolpidem tartrate 10 mg administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast. arm 2: A single dose of Ambien® 10 mg administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 10 mg tablet administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast. intervention 2: 10 mg tablet administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast. | intervention 1: Zolpidem Tartrate 10 mg tablet intervention 2: Zolpidem Tartrate 10 mg tablet (Ambien®) | 0 | null | 0 | NCT00658541 | |
[
2
] | 38 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available reference drug product Ambien® (zolpidem tartrate tablets) in adult subjects under fasted conditions. | The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available reference drug product Ambien® (zolpidem tartrate tablets) in adult subjects under fasted conditions.
Thirty-eight healthy, non-smoking, non-obese male ... | Healthy | equivalency Therapeutic equivalency | null | 2 | arm 1: A single dose of zolpidem tartrate 10 mg administered after an overnight fast of at least 10 hours. arm 2: A single dose of Ambien® 10 mg administered after an overnight fast of at least 10 hours. | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 10 mg tablet administered after an overnight fast of at least 10 hours intervention 2: 10 mg tablet administered after an overnight fast of at least 10 hours | intervention 1: Zolpidem Tartrate 10 mg tablet intervention 2: Zolpidem Tartrate 10 mg tablet (Ambien®) | 0 | null | 0 | NCT00684814 |
[
3
] | 423 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | To evaluate the positive efficacy trend among doses of saxagliptin (BMS-477118) in subjects with Type 2 diabetes mellitus by assessing the change from baseline in HbA1c following 12 weeks of double-blind treatment. | null | Type 2 Diabetes Mellitus | null | 7 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None | [
0,
0,
0,
0,
0,
0,
2
] | 7 | [
0,
0,
0,
0,
0,
0,
0
] | intervention 1: Tablets, Oral, 2.5 mg, once daily, 12 weeks intervention 2: Tablets, Oral, 5 mg, once daily, 12 weeks intervention 3: Tablets, Oral, 10 mg, once daily, 12 weeks intervention 4: Tablets, Oral, 20 mg, once daily, 12 weeks intervention 5: Tablets, Oral, 40 mg, once daily, 12 weeks intervention 6: Tablets, ... | intervention 1: Saxagliptin intervention 2: Saxagliptin intervention 3: Saxagliptin intervention 4: Saxagliptin intervention 5: Saxagliptin intervention 6: Saxagliptin intervention 7: Placebo | 0 | null | 0 | NCT00950599 | |
[
4
] | 19 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The primary objective of this study was to determine the efficacy of etanercept in pediatric patients with systemically active system onset juvenile rheumatoid arthritis (SOJRA). | Participants were to receive etanercept at a dose of 0.4 mg/kg twice weekly in Part 1A. Participants who had a partial response (not able to reduce prednisone dose by 50% of the baseline dose in 5 months) while on 0.4 mg/kg twice weekly etanercept in Part 1A were to enter Part 1B for up to 4 months and were to have the... | Juvenile Rheumatoid Arthritis | Systemic Onset Juvenile Rheumatoid Arthritis SOJRA Fever Rash Joint Pain | null | 4 | arm 1: Participants received 0.4 mg/kg etanercept administered subcutaneously twice a week for up to 6 months in Part 1A.
Participants who had a partial response entered Part 1B and received 0.8 mg/kg etanercept twice weekly for up to 4 months. arm 2: Participants who met response criteria in Part 1 were randomized to... | [
0,
2,
0,
0
] | 2 | [
0,
0
] | intervention 1: Administered by subcutaneous injection twice a week intervention 2: Administered by subcutaneous injection twice a week | intervention 1: Etanercept intervention 2: Placebo | 0 | null | 0 | NCT00078806 |
[
3
] | 175 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | Glutamate is fundamentally involved in learning and memory. Memory loss associated with mild cognitive impairment may be due to loss of glutamate receptors in the aging brain. There is evidence CX516 enhances brain activity by specifically targeting remaining glutamate receptors in the affected portions of the brain. T... | null | Mild Cognitive Impairment | Mild Cognitive Impairment Memory Loss Alzheimer's Disease Brain Aging Ampalex® CX516 | null | 2 | arm 1: CX516 - 900 mg arm 2: Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: CX516 intervention 2: Placebo | 8 | Peoria | Arizona | United States | -112.23738 | 33.5806
Irvine | California | United States | -117.82311 | 33.66946
Los Angeles | California | United States | -118.24368 | 34.05223
San Diego | California | United States | -117.16472 | 32.71571
New Haven | Connecticut | United States | -72.92816 | 41.30815
Tampa | Flori... | 0 | NCT00040443 |
[
4
] | 529 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind tre... | Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. | Osteoarthritis | Chronic pain opioid transdermal osteoarthritis | null | 2 | arm 1: Buprenorphine transdermal patch 5, 10 or 20 micrograms/hour (mcg/h) arm 2: Placebo to match BTDS 5, 10 or 20 mcg/h | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear. intervention 2: Placebo to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear. | intervention 1: Buprenorphine transdermal patch intervention 2: Placebo | 44 | Mesa | Arizona | United States | -111.82264 | 33.42227
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Bakersfield | California | United ... | 0 | NCT00313846 |
[
3
] | 72 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The objective of this trial is to determine the optimal region of the lung for depositing Prolastin (alpha-1 antitrypsin; AAT) by inhalation in order to treat cystic fibrosis (CF). The AKITA® nebulizer has settings which can be varied to target the inhaled drug to either the deep lung or to the upper airways in a one t... | The optimum deposition site (bronchial or peripheral) in CF patients for AAT will be investigated by measuring several parameters in induced sputum. The study will start with a 2 week run-in period in which the planned 60 patients inhale isotonic saline once daily. This period is followed by a 4 week treatment period w... | Cystic Fibrosis | null | 2 | arm 1: Bronchial Deposition Intervention: Alpha1-Proteinase Inhibitor (Human) Dosage: 25 mg in lungs, one inhalation per day over 4 weeks arm 2: Peripheral Deposition Intervention: Alpha1-Proteinase Inhibitor (Human) Dosage: 25 mg in lungs, one inhalation per day over 4 weeks | [
0,
0
] | 1 | [
0
] | intervention 1: 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks. | intervention 1: Alpha1-Proteinase Inhibitor (Human) | 0 | null | 0 | NCT00486837 | |
[
0
] | 10 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 0NONE | true | 2MALE | false | Sedation may be necessary in intensive care to facilitate diverse therapeutic interventions, but the use of sedative drugs may increase the risk of delirium and long-term cognitive impairment. Thus the implementation and monitoring of sedation remains difficult despite the use of sedation protocols and clinical sedatio... | Sedation may be necessary in intensive care to facilitate diverse therapeutic interventions, but the use of sedative drugs may increase the risk of delirium and long-term cognitive impairment. Thus the implementation and monitoring of sedation remains difficult despite the use of sedation protocols and clinical sedatio... | Conscious Sedation Deep Sedation Critical Care | dexmedetomidine midazolam remifentanil Electroencephalography Event related potentials BIS Bispectral Index Response Entropy State Entropy | null | 2 | arm 1: Sedation with dexmedetomidine and remifentanil followed by sedation with midazolam and remifentanil separated by one week arm 2: Sedation with midazolam and remifentanil followed by sedation with dexmedetomidine and remifentanil separated by one week | [
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: Infusion of dexmedetomidine intervention 2: Midazolam infusion intervention 3: Infusion of remifentanil | intervention 1: Dexmedetomidine intervention 2: Midazolam intervention 3: Remifentanil | 1 | Bern | N/A | Switzerland | 7.44744 | 46.94809 | 0 | NCT00641563 |
[
2
] | 22 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | The purpose of this study is to compare the bioequivalence of a test formulation of primidone tablets to an equivalent oral dose of the commercially available Mysoline®(primidone tablets) in adult subjects under fasting conditions. | The purpose of this study is to compare the bioequivalence of a test formulation of primidone tablets to an equivalent oral dose of the commercially available Mysoline® (primidone tablets) in adult subjects under fasting conditions.
Twenty-two healthy, non-smoking, non-obese male and female volunteers at least 18 year... | Therapeutic Equivalency | null | 2 | arm 1: A single dose of primidone 50 mg administered after an overnight fast of at least 10 hours. arm 2: A single dose of Mysoline® 50 mg administered after an overnight fast of at least 10 hours. | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 50 mg tablet administered after an overnight fast of at least 10 hours. intervention 2: 50 mg tablet administered after an overnight fast of at least 10 hours. | intervention 1: Primidone 50 mg Tablet intervention 2: Primidone (Mysoline®) 50 mg Tablet | 0 | null | 0 | NCT00685165 | |
[
2
] | 24 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 1SINGLE | true | 0ALL | false | The purpose of this study is to evaluate and compare the dose proportionality of 324 mg Quinine Sulfate capsules following a single oral dose (1 x 324 mg capsules versus 2 x 324 mg capsules) in healthy adult volunteers when administered under fasting conditions. | The purpose of this study is to evaluate and compare the dose proportionality of 324 mg Quinine Sulfate capsules following a single oral dose (1 x 324 mg capsules versus 2 x 324 mg capsules) in healthy adult volunteers when administered under fasting conditions.
Twenty-four healthy, non-smoking, non-obese, male and fe... | Healthy | Bioavailability | null | 2 | arm 1: Quinine Sulfate 1 x 324 mg capsule dose. arm 2: Quinine Sulfate 2 x 324 mg capsules dose. | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 1 x 324 mg capsule intervention 2: 2 x 324 mg capsules | intervention 1: Quinine Sulfate Capsules 324 mg intervention 2: Quinine Sulfate Capsules 324 mg | 0 | null | 0 | NCT00726895 |
[
5
] | 24 | RANDOMIZED | PARALLEL | 7BASIC_SCIENCE | 0NONE | false | 1FEMALE | false | An open-label, randomized, parallel group trial in healthy female subjects to compare the pharmacokinetics of ethinyl estradiol (EE) of NuvaRing®, a contraceptive patch (EVRA(TM)) and an oral contraceptive (Microgynon® 30). | null | Contraception | null | 3 | arm 1: Microgynon(R), 1 tablet every day for 21 days; each tablet contains 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE). arm 2: Evra(TM), One patch applied on lower abdomen for 7 days for 3 consecutive weeks, 3 patches in total. Each patch contains 6 mg norelgestromin and 0.750 mg EE releasing 0.150... | [
1,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: LNG/EE oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days. intervention 2: A contraceptive patch (EVRA ™), one patch for 7 days for three consecutive weeks, 3 patches in total, applied on the... | intervention 1: Levonorgestrel (LNG)/Ethinylestradiol (EE) oral contraceptive tablets intervention 2: norelgestrominum and ethinylestradiol patch oral contraceptive patch intervention 3: Nuvaring ™ (etonorgestrel/ethinylestradiol) | 0 | null | 0 | NCT01044056 | |
[
3
] | 45 | RANDOMIZED | SEQUENTIAL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The primary objective of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with ITP. | null | Idiopathic Thrombocytopenic Purpura | Immune Thrombocytopenic Purpura Idiopathic Thrombocytopenic Purpura Thrombocytopenic Thrombocytopenia ITP | null | 10 | arm 1: Participants received 0.2 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. arm 2: Participants received 0.5 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. arm 3: Participants received 1.0 µg/kg romiplostim subcutaneously on day 1... | [
0,
0,
0,
0,
0,
0,
2,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: Administered by subcutaneous injection intervention 2: Administered by subcutaneous injection | intervention 1: Romiplostim intervention 2: Placebo | 0 | null | 0 | NCT00111475 |
[
3
] | 11 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Current therapies for children with low grade astrocytomas that have not responded to standard therapy provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with low grade astrocytomas that have not respo... | OBJECTIVES:
* To determine the efficacy of Antineoplaston therapy in children with low grade gliomas that has not responded to standard therapy, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in ... | Low Grade Astrocytomas | childhood low-grade astrocytoma recurrent childhood astrocytoma persistent childhood astrocytoma | null | 1 | arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. | [
0
] | 1 | [
0
] | intervention 1: Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal). | intervention 1: Antineoplaston therapy (Atengenal + Astugenal) | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00003468 |
[
3
] | 129 | null | null | 0TREATMENT | 0NONE | false | 1FEMALE | null | The purpose of this study is to determine if the study drug pertuzumab is effective in treating patients with advanced ovarian cancer that is refractory to, or has recurred following, prior chemotherapy. | null | Ovarian Cancer | Advanced, refractory, or recurrent ovarian cancer | null | 0 | null | null | 1 | [
0
] | intervention 1: None | intervention 1: Pertuzumab (rhuMAb 2C4) | 0 | null | 0 | NCT00058552 |
[
3
] | 12 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The study tests the safety and efficacy of axitinib in patients who have the hematologic disease of Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study tests patients who have poor prognosis before entering the study. | null | Acute Myeloid Leukemia (AML) Myelodysplastic Syndrome | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: patients were treated with axitinib at starting dose of 5 mg BID continuous dosing. | intervention 1: AG-013736 (Axitinib) | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00071006 | |
[
4
] | 204 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention duration is 2 weeks during which time suppl... | Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. | Osteoarthritis | Osteoarthritis, opioid, transdermal | null | 2 | arm 1: Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their doses adjusted to BTDS 20 (Level 2) on or after day 4. arm 2: Initial doses (Level 1) of BTDS 20. | [
0,
0
] | 1 | [
0
] | intervention 1: Buprenorphine transdermal patch applied for 7-day wear. | intervention 1: Buprenorphine transdermal patch | 36 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Tucson | Arizona | United States | -110.92648 | 32.22174
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Pine Bluff | Arkansas | Uni... | 0 | NCT00312572 |
[
2
] | 54 | RANDOMIZED | CROSSOVER | null | 1SINGLE | true | 2MALE | false | The purpose of this study is to evaluate and compare the relative bioavailability and therefore the bioequivalence of a test formulation of Lovastatin tablets to an equivalent dose of Mevacor® tablets after a single oral dose administered under fed conditions. | The purpose of this study is to evaluate and compare the relative bioavailability and therefore the bioequivalence of a test formulation of Lovastatin tablets to an equivalent dose of Mevacor® tablets after a single oral dose administered under fed conditions.
Fifty-four healthy, light/non/or ex-smoking, non-obese, ma... | Healthy | Therapeutic Equivalency | null | 2 | arm 1: A single dose of Lovastatin 40 mg administered under fed conditions. arm 2: A single dose of Lovastatin (Mevacor®) 40 mg administered under fed conditions. | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 40 mg tablet administered 30 minutes following the start of a standardized high-fat, high-calorie breakfast intervention 2: 40 mg tablet administered 30 minutes following the start of a standardized high-fat, high-calorie breakfast | intervention 1: Lovastatin 40 mg Tablets intervention 2: Lovastatin (Mevacor®) 40 mg Tablets | 1 | Montreal | Quebec | Canada | -73.58781 | 45.50884 | 0 | NCT00684723 |
[
2
] | 32 | RANDOMIZED | CROSSOVER | null | 0NONE | true | 0ALL | false | The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a single oral dose administered under fasting conditions. | The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a single oral dose administered under fasting conditions. Thirty-two non-smoking, non-obese, healthy male and female volunteers betwee... | Therapeutic Equivalency, Healthy | null | 2 | arm 1: A single dose of cilostazol (2 x 50 mg tablets) administered after an overnight fast of at least 10 hours. arm 2: A single dose of Cilostazol (Pletal® tablets, 2 x 50 mg ) administered after an overnight fast of at least 10 hours. | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Cilostazol (2 x 50 mg tablets) administered after an overnight fast of at least 10 hours intervention 2: Cilostazol (Pletal® Tablets, 2 x 50mg) administered after an overnight fast of at least 10 hours. | intervention 1: Cilostazol 50 mg Tablets intervention 2: Cilostazol (Pletal®) 50 mg Tablets | 0 | null | 0 | NCT00685802 | |
[
4
] | 20 | NA | SINGLE_GROUP | 7BASIC_SCIENCE | 0NONE | false | 0ALL | false | A single center pilot study to determine the protective effects of RhuMAB-E25 on airway physiology and biology in allergic asthmatics that undergo bronchoprovocation with methacholine.
The primary study objective determines the protective impact of RhuMAB-E25 on airway inflammation as reflected in exhaled nitric oxide... | This is a single center prospective, open-label study. Eligible subjects will undergo two baseline measurements of exhaled Nitric Oxide (NO) before and after methacholine challenge testing at least one week apart. All subjects will receive treatment with RhuMAB-E25 in an open label fashion at day 0, weeks 4 and 8, and ... | Allergic Asthma | Asthma | null | 0 | null | null | 1 | [
0
] | intervention 1: three subcutaneous injections spaced 1 month apart; dose based on subject weight and baseline IgE level. | intervention 1: RhuMab-E25 | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 0 | NCT00829179 |
[
4
] | 392 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to collect information regarding the long-term (6 and 12 months) safety of Tramadol HCl Once-A-Day(OAD) 300 mg. | null | Osteoarthritis, Knee | Moderate to severe symptomatic osteoarthritis of the knee | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Tramadol Once A Day | 0 | null | 0 | NCT00833911 |
[
2
] | 56 | RANDOMIZED | CROSSOVER | null | 0NONE | true | 0ALL | null | The object of this study is to compare the relative bioavailability of lansoprazole 30 mg delayed-release capsules (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of PREVACID® capsules (TAP Pharmaceuticals, Inc.) in healthy, adult, subjects under fasting cond... | Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA Bioequivalence Statistical Methods | Healthy | Bioequivalence Healthy Subjects | null | 2 | arm 1: Lansoprazole 30 mg delayed-release Capsules arm 2: Prevacid® 30 mg delayed-release Capsules | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 30 mg delayed-release Capsule intervention 2: 30 mg delayed-release Capsule | intervention 1: Lansoprazole intervention 2: Prevacid® | 1 | Fargo | North Dakota | United States | -96.7898 | 46.87719 | 0 | NCT01045967 |
[
4
] | 290 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS). | Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. Transdermal systems may offer advantages over currently indicated oral products including ease an... | Osteoarthritis | Osteoarthritis Opioid Transdermal | null | 1 | arm 1: Buprenorphine transdermal patch | [
0
] | 3 | [
0,
0,
0
] | intervention 1: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear intervention 2: Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear intervention 3: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear | intervention 1: Buprenorphine transdermal patch intervention 2: Buprenorphine transdermal patch intervention 3: Buprenorphine transdermal patch | 42 | Mesa | Arizona | United States | -111.82264 | 33.42227
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Bakersfield | California | United ... | 0 | NCT01141283 |
[
2,
3
] | 16 | NA | SEQUENTIAL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to assess the safety and tolerability of AMG 531 (romiplostim), a novel thrombopoiesis-stimulating peptibody, and its effect on platelet counts in adults with immune thrombocytopenic purpura. | null | Thrombocytopenic Purpura | Immune Thrombocytopenic Purpura Idiopathic Thrombocytopenic Purpura ITP Thrombocytopenia | null | 1 | arm 1: Participants will receive a maximum of 2 administrations of romiplostim by subcutaneous injection, the first on day 1 of the study and the second on day 15 or 22 depending on the participant's platelet count. Romiplostim doses to be tested were 30, 100, 300, and 500 μg. | [
0
] | 1 | [
0
] | intervention 1: Administered subcutaneously on day 1 and on day 15 or 22 if the platelet count was ≤ 50 x 10⁹/L and not rising, peak platelet count was ≤ 450 x 10⁹/L and no serious adverse events related to treatment were observed. | intervention 1: Romiplostim | 0 | null | 0 | NCT00117143 |
[
3
] | 174 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The objective of this trial was to explore the dose-response relation of sugammadex (Org 25969; MK-8616) administered for the reversal of neuromuscular blockade (NMB) at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® (rocuronium) in participants receiving surgery, classified as American Soci... | In the United States, the highest dose recommended in the package insert of Zemuron® (i.e. the trade name for Esmeron® in the US) is 1.2 mg/kg whereas in Europe it is 1.0 mg/kg. For both doses, dose recommendations for reversal with sugammadex were to be found. Hence, the present trial was set up to explore the dose-re... | Anesthesia, General | null | 24 | arm 1: Placebo (single intravenous (IV) bolus) administered 3 minutes (min) after the bolus intubation dose of 1 mg/kg Esmeron®. arm 2: Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®. arm 3: Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the ... | [
2,
0,
0,
0,
0,
0,
2,
0,
0,
0,
0,
0,
2,
0,
0,
0,
0,
0,
2,
0,
0,
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight. intervention 2: 0.9% NaCl administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes... | intervention 1: Sugammadex intervention 2: Placebo intervention 3: Esmeron® | 0 | null | 0 | NCT00535743 | |
[
5
] | 674 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | false | The purpose of this research study is to:
1. compare the effectiveness of a nicotine patch and nicotine nasal spray for smoking cessation; and
2. identify predictors of response to these alternate forms of nicotine replacement therapy (NRT). | The ultimate objective is to obtain information necessary to match NRT to those smokers with the greatest need and likelihood of benefit. The investigators hypothesize that the nicotine nasal spray (NS) will result in significantly higher abstinence rates than transdermal nicotine (TN) for the following subgroups of sm... | Smoking | Nicotine nasal spray + counseling Transdermal nicotine + counseling | null | 2 | arm 1: None arm 2: None | [
1,
1
] | 2 | [
0,
0
] | intervention 1: The dosing schedule is as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours. Treatment lasted 8 weeks. intervention 2: 8 weeks of self-administered nicotine nasal spray at 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray d... | intervention 1: Nicoderm Transdermal Patch intervention 2: Nicotine Nasal Spray | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00326781 |
[
2
] | 36 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the study was to characterize the safety of investigational agent AG-013736, in patients with solid tumors in this First In Human trial. | null | Advanced Solid Tumors | null | 6 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None | [
0,
0,
0,
0,
0,
0
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: Axitinib continuous oral dosing (10 mg once a day, 10 mg twice a day, 20 mg twice a day or 30 mg twice day) in the fed state intervention 2: Axitinib continuous oral dosing (20 mg twice a day) in the fed state intervention 3: Axitinib continuous oral dosing (5 mg twice a day) in the fed state interventi... | intervention 1: AG-013736 intervention 2: AG-013736 intervention 3: AG-013736 intervention 4: AG-013736 intervention 5: AG-013736 intervention 6: AG-013736 | 3 | San Francisco | California | United States | -122.41942 | 37.77493
Houston | Texas | United States | -95.36327 | 29.76328
Madison | Wisconsin | United States | -89.40123 | 43.07305 | 0 | NCT01469052 | |
[
3
] | 201 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. This study will measure how well TD-6424 (Telavancin) can control infections and whether the drug is safe to give to patients. | null | Infections, Gram-positive Bacterial | Abscess Burns Cellulitis Ulcer Wound infections | null | 2 | arm 1: None arm 2: cSSSI - comlicated skin and skin structure infections | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Telavancin 7.5 mg/kg/day, amended to 10 mg/kg/day, IV (intravenously) for up to 14 days intervention 2: Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days. | intervention 1: Telavancin intervention 2: vancomycin or antistaphylococcal penicillin | 1 | National City | California | United States | -117.0992 | 32.67811 | 0 | NCT00077675 |
[
5
] | 89 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are not receiving erythropoietic agents (hormones that stimulate the bone marrow to make more red blood cells). | null | Anemia, Iron-Deficiency Kidney Failure, Chronic | Iron deficiency Anemia Chronic kidney disease Sodium Ferric Gluconate Anemia, Iron-Deficiency/drug therapy/etiology Kidney Failure, Chronic/blood/complications/therapy | null | 2 | arm 1: Sodium ferric gluconate arm 2: ferrous sulfate | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Sodium Ferric Gluconate Complex in Sucrose Injection (Ferrlecit®), 250 mg IV weekly for 4 weeks intervention 2: ferrous sulfate, 325 mg oral, three times daily for 6 weeks | intervention 1: Sodium Ferric Gluconate Complex in Sucrose Injection intervention 2: Ferrous sulfate tablets | 24 | Tucson | Arizona | United States | -110.92648 | 32.22174
Los Angeles | California | United States | -118.24368 | 34.05223
Palo Alto | California | United States | -122.14302 | 37.44188
San Diego | California | United States | -117.16472 | 32.71571
Hines | Illinois | United States | -87.8395 | 41.85364
Indianapolis | In... | 0 | NCT00224055 |
[
2
] | 36 | RANDOMIZED | CROSSOVER | 9OTHER | 0NONE | true | 0ALL | false | The objective of this study was to compare the rate and extent of absorption of Teva Pharmaceuticals USA valacyclovir and GlaxoSmithKline, USA (Valtrex) valacyclovir, administered as 1 x 1000 mg tablet under fed conditions. | null | Healthy | null | 2 | arm 1: Test 1000 mg Tablet arm 2: Reference Listed Valacyclovir 1000 mg Tablet | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Test 1000 mg Tablet intervention 2: Reference Listed Valacyclovir 1000 mg Tablet | intervention 1: Valacyclovir intervention 2: Valacyclovir | 1 | Sainte-Foy | Quebec | Canada | -71.29217 | 46.78139 | 0 | NCT01149460 | |
[
4
] | 332 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This was a Phase 3 multicenter extension of Alkermes' Study ALK21-003 (NCT01218958 \[the base study\]) that evaluated the safety of Medisorb® naltrexone (VIVITROL®) administered every 4 weeks for 48 weeks (13 injections) in alcohol-dependent adults who had completed Study ALK21-003. | All participants in this study received Medisorb naltrexone at double-blinded dose strengths (ie, 190 mg or 380 mg); no participant received placebo. Participants who had received Medisorb naltrexone in Study ALK21-003 (NCT01218958) continued to receive the same dose strength in this extension study. Those who had rece... | Alcohol Dependence | Alcohol Dependence | null | 2 | arm 1: Intramuscular (IM) injection administered once every 4 weeks for up to 48 weeks. arm 2: IM injection administered once every 4 weeks for up to 48 weeks. | [
0,
0
] | 2 | [
0,
0
] | intervention 1: naltrexone for extended-release injectable suspension intervention 2: naltrexone for extended-release injectable suspension | intervention 1: Medisorb naltrexone 190 mg intervention 2: Medisorb naltrexone 380 mg | 0 | null | 0 | NCT01218971 |
[
3
] | 42 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | null | The purpose of this study is to evaluate safety and efficacy of Omnitarg (Pertuzumab) on cancerous lesions in men with castration-resistant (hormone-refractory) prostate cancer. | null | Prostate Cancer | null | 0 | null | null | 1 | [
0
] | intervention 1: None | intervention 1: rhuMAb 2C4 (pertuzumab) | 0 | null | 0 | NCT00058539 | |
[
4
] | 263 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with residual excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulnes... | null | Obstructive Sleep Apnea Sleep Hypopnea | Excessive Sleepiness Obstructive Sleep Apnea Obstructive Sleep Hypopnea nCPAP Cephalon Cephalon, Inc Nuvigil | null | 2 | arm 1: Armodafinil 150 mg/day arm 2: Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Armodafinil 150 mg once daily in the morning intervention 2: Matching placebo tablets once daily | intervention 1: Armodafinil 150 mg/day intervention 2: Placebo | 0 | null | 0 | NCT00079677 |
[
4
] | 62 | RANDOMIZED | CROSSOVER | 1PREVENTION | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine the effect of an approved medication being studied in support of a new approach in the prevention of exercise-induced asthma (a worsening of asthma caused by exercise, also known as exercise-induced bronchospasm), in patients who have a history of worsening asthma after exercis... | null | Asthma, Exercise-Induced | null | 2 | arm 1: Montelukast - Placebo arm 2: Placebo - Montelukast | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge intervention 2: Placebo tablet administered orally as a single witnessed dose before exercise challenge | intervention 1: Comparator: Montelukast intervention 2: Comparator: Placebo | 0 | null | 0 | NCT00090142 | |
[
4
] | 121 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis. | This is an open-label, prospective study comparing IV iron supplementation to standard care in anemic patients undergoing peritoneal dialysis. After successfully completing a 6 month enrollment period, qualifying patients were randomized to receive 1000mg of IV iron over a four week period, or no iron supplementation. ... | Anemia | iron peritoneal dialysis anemia | null | 2 | arm 1: Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29. arm 2: Stable erythropoietin (EPO) dose and no supplemental iron. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29. intervention 2: Stable erythropoietin (EPO) dose and no supplemental iron. | intervention 1: Venofer and stable erythropoietin (EPO) regimen intervention 2: stable erythropoietin (EPO) regimen | 0 | null | 0 | NCT00236938 |
[
4
] | 182 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin. | The intent of this study was to assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure patients receiving or not receiving erythropoietin. After an extensive enrollment period, patients were randomized to receive oral iron (ferrous sulfat... | Anemia | CKD iron anemia | null | 2 | arm 1: iron sucrose injection arm 2: oral iron | [
0,
1
] | 2 | [
0,
0
] | intervention 1: iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14. intervention 2: oral iron tablets; 325 mg three times a day orally for 56 days | intervention 1: Venofer intervention 2: Ferrous Sulfate | 1 | Valley Forge | Pennsylvania | United States | -76.70747 | 39.98454 | 0 | NCT00236977 |
[
2
] | 54 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 0ALL | false | The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of inhaled prochlorperazine | The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of a single, inhaled dose of prochlorperazine (PCZ), administered as 1 or 2 puffs in healthy young volunteers. | Migraine | Migraine, Prochlorperazine aerosol | null | 6 | arm 1: Prochlorperazine 0.5 mg IV over 5 sec crossover Inhaled prochlorperazine 0.625 mg arm 2: Inhaled Staccato prochlorperazine 1.25 mg arm 3: Inhaled Staccato prochlorperazine 2.5 mg arm 4: Inhaled Staccato prochlorperazine 5 mg arm 5: Inhaled Staccato prochlorperazine 10 mg arm 6: inhaled Staccato Placebo (0 mg) | [
0,
0,
0,
0,
0,
2
] | 8 | [
0,
0,
0,
0,
0,
0,
0,
0
] | intervention 1: IV Prochlorperazine for bioavailability intervention 2: Inhaled Staccato Prochlorperazine 0.625 mg intervention 3: Inhaled Staccato Prochlorperazine 1.25 mg intervention 4: Inhaled Staccato Prochlorperazine 2.5 mg intervention 5: InhaledStaccato Prochlorperazine 5 mg intervention 6: InhaledStaccato Proc... | intervention 1: Prochlorperazine 0.5 mg IV over 5 sec intervention 2: Inhaled prochlorperazine 0.625 mg intervention 3: Inhaled prochlorperazine 1.25 mg intervention 4: Inhaled prochlorperazine 2.5 mg intervention 5: Inhaled prochlorperazine 5 mg intervention 6: Inhaled prochlorperazine 10 mg intervention 7: Inhaled pl... | 1 | Austin | Texas | United States | -97.74306 | 30.26715 | 0 | NCT00610727 |
[
2
] | 54 | RANDOMIZED | CROSSOVER | null | 1SINGLE | true | 2MALE | false | The purpose of this study is to evaluate and compare the relative bioavailability and therefore the bioequivalence of a test formulation of lovastatin tablets to an equivalent dose of Mevacor® tablets after a single oral dose administered under fasting conditions. | The purpose of this study is to evaluate and compare the relative bioavailability and therefore the bioequivalence of a test formulation of lovastatin tablets to an equivalent dose of Mevacor® tablets after a single oral dose administered under fasting conditions.
Fifty-four healthy, light/non/or ex-smoking, non-obese... | Healthy | Therapeutic Equivalency | null | 2 | arm 1: A single dose of Lovastatin 40 mg administered after an overnight fast of at least 10 hours. arm 2: A single dose of Lovastatin (Mevacor®) 40 mg administered after an overnight fast of at least 10 hours. | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 40 mg tablet administered after an overnight fast of at least 10 hours intervention 2: 40 mg tablet administered after an overnight fast of at least 10 hours | intervention 1: Lovastatin 40 mg tablets intervention 2: Lovastatin (Mevacor®) 40 mg Tablets | 1 | Montreal | N/A | Canada | -73.58781 | 45.50884 | 0 | NCT00685685 |
[
4
] | 324 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study is to determine the efficacy of SPD503 compared to placebo in the treatment of children and adolescents aged 6-17 with ADHD. | null | Attention Deficit Disorder With Hyperactivity | null | 5 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None | [
0,
0,
0,
0,
2
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None | intervention 1: SPD503 (1 mg) intervention 2: SPD503 (2 mg) intervention 3: SPD503 (3 mg) intervention 4: SPD503 (4 mg) intervention 5: Placebo | 0 | null | 0 | NCT00150618 | |
[
4
] | 69 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | OBJECTIVES:
Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants. | PROTOCOL OUTLINE:
This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
Arm I: Patients receive lucinactant by bronchoalveolar lavage, into the right and left lung, followed by lung drainage. Treatment repeats when patient stabilizes or every 15 minutes for 2 courses.
Arm II:... | Meconium Aspiration | cardiovascular and respiratory diseases meconium aspiration syndrome rare disease | null | 2 | arm 1: Lucinactant via bronchoaveolar lavage arm 2: Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization | [
0,
5
] | 2 | [
0,
10
] | intervention 1: Lucinactant suspension was administered as 10 mg total phospholipid (TPL)/mL, by bronchoalveolar lavage within 90 minutes of randomization. The dose was determined based on the infant's body weight such that the total dose was 16 mL/kg for each of the 2 lavage procedures and 32 mL/kg overall. Infants re... | intervention 1: Lucinactant intervention 2: Standard Care | 1 | Warrington | Pennsylvania | United States | -75.13406 | 40.24927 | 0 | NCT00004500 |
[
3
] | 65 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals. | null | Anemia | null | 9 | arm 1: Eligible participants will be receiving RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) at a dose of 0.15 microgram per kilogram (mcg/kg) subcutaneously (SC) once every week to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants will be followed-up for one week post ... | [
0,
0,
0,
0,
0,
0,
0,
0,
0
] | 1 | [
0
] | intervention 1: Differing doses and frequencies of sc administration | intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera] | 15 | Birmingham | Alabama | United States | -86.80249 | 33.52066
San Diego | California | United States | -117.16472 | 32.71571
Detroit | Michigan | United States | -83.04575 | 42.33143
Detroit | Michigan | United States | -83.04575 | 42.33143
Las Vegas | Nevada | United States | -115.13722 | 36.17497
Portland | Oregon | Un... | 0 | NCT00048048 | |
[
4
] | 231 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be required to make 5 visits over up to 14 weeks to a participating expert physician practitioner for various sleep and narcolepsy eval... | null | Narcolepsy | Narcolepsy Daytime Sleepiness Daytime sleepiness in narcolepsy | null | 4 | arm 1: Xyrem + Modafinil Placebo arm 2: Xyrem Placebo + Modafinil Placebo arm 3: Xyrem Placebo + Modafinil at established dose arm 4: Xyrem + Modafinil at established dose | [
0,
2,
1,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Xyrem oral solution at 6 g/day for 4 weeks and 9 g/day for another 4 weeks. intervention 2: Xyrem Placebo oral solution 12 ml per day for 4 weeks and 18 ml per day for another 4 weeks. intervention 3: Modafinil oral capsules at 200 to 600 mg per day for 8 weeks. intervention 4: Modafinil Placebo oral ca... | intervention 1: Xyrem intervention 2: Xyrem Placebo intervention 3: Modafinil at established dose intervention 4: Modafinil (Placebo) | 40 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Fullerton | California | United States | -117.92534 | 33.87029
Los Angeles | California | United States | -118.24368 | 34.05223
Pasadena | California | United States | -118.14452 | 34.14778
San Diego | California | United States | -117.16472 | 32.71571
Stanford ... | 0 | NCT00066170 |
[
4
] | 395 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (M... | null | Obstructive Sleep Apnea Hypopnea | Excessive Sleepiness Obstructive Sleep Apnea Obstructive Sleep Hypopnea nCPAP Cephalon Cephalon, Inc NUVIGIL | null | 3 | arm 1: Armodafinil 250 mg/day arm 2: Armodafinil 150 mg/day arm 3: Placebo | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Armodafinil 250 mg once daily in the morning intervention 2: Armodafinil 150 mg once daily in the morning intervention 3: Matching placebo tablets once daily in the morning | intervention 1: Armodafinil 250 mg/day intervention 2: Armodafinil 150 mg/day intervention 3: Placebo | 0 | null | 0 | NCT00078325 |
[
4
] | 938 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | true | 1FEMALE | false | This is a comparative study. The primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding of norethindrone acetate/ethinyl estradiol (NETA/EE) administered for 24 days and NETA/E... | null | Prevention of Pregnancy | Contraception | null | 2 | arm 1: Norethindrone acetate 1 mg /ethinyl estradiol 20 mcg for 24 days of each 28 day cycle arm 2: Norethindrone acetate 1 mg/ethinyl estradiol 20 mcg for 21 days of each 28 day cycle | [
0,
1
] | 2 | [
0,
0
] | intervention 1: One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets intervention 2: One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets | intervention 1: Norethindrone Acetate/Ethinyl Estradiol 24 Days intervention 2: Norethindrone Acetate /Ethinyl Estradiol 21 Days | 34 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Chico | California | United States | -121.83748 | 39.72849
Los Angeles | California | United States | -118.24368 | 34.05223
San Diego | Californ... | 0 | NCT00932321 |
[
2
] | 12 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 0ALL | null | This study will establish that the MK0431 100 mg anhydrous formulation tablets are bioequivalent to the MK0431 100 mg monohydrate final market image (FMI) tablets. | null | Type 2 Diabetes Mellitus | null | 2 | arm 1: Sitagliptin anhydrous formulation arm 2: Sitagliptin monohydrate FMI formulation | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Single dose sitagliptin 100 mg tablets (anhydrous form) in one of two treatment periods. intervention 2: Single dose sitagliptin 100 mg tablets \[monohydrate Final Market Image (FMI) form\] in one of two treatment periods. | intervention 1: Sitagliptin phosphate anhydrous formulation intervention 2: Comparator: sitagliptin phosphate monohydrate form | 0 | null | 0 | NCT00944450 | |
[
2
] | 32 | RANDOMIZED | CROSSOVER | 9OTHER | 0NONE | true | 2MALE | false | The objective of this study is to evaluate the comparative bioavailability between tamsulosin hydrochloride 0.4 mg capsules (Manufactured by Teva Pharmaceutical Industries Ltd.; distributed by Teva Pharmaceuticals USA) and Flomax® (tamsulosin hydrochloride)0.4 mg capsules (Manufactured by Yamanouchi Pharmaceutical Co.,... | null | Healthy | null | 2 | arm 1: 0.4 mg Capsule arm 2: 0.4 mg Capsule | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Test 0.4 mg Capsule intervention 2: Reference Listed 0.4 Capsule | intervention 1: Tamsulosin intervention 2: Tamsulosin | 1 | Toronto | Ontario | Canada | -79.39864 | 43.70643 | 0 | NCT01149733 | |
[
3
] | 502 | RANDOMIZED | PARALLEL | 1PREVENTION | null | false | 0ALL | null | The purpose of this trial is to evaluate the safety of different doses of BIBR 1048, alone or in combination with acetylsalicylic acid (ASA), as determined by the rates of bleeding and other adverse events.
A secondary objective of this trial is to evaluate the anticoagulant effect of different doses of BIBR 1048, bas... | null | Atrial Fibrillation | null | 10 | arm 1: Dabigatran: one capsule in the morning and 1 capsule in the evening. Twice daily (bis in die = bid). arm 2: Dabigatran: one capsule in the morning and 1 capsule in the evening. Acetylsalicylic acid (ASA) once daily (quaque dies = qd) in the morning. arm 3: Dabigatran: one capsule in the morning and 1 capsule in ... | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
1
] | 10 | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] | intervention 1: dose comparison in combination intervention 2: dose comparison in combination intervention 3: dose comparison in combination intervention 4: dose comparison in combination intervention 5: dose comparison in combination intervention 6: dose comparison in combination intervention 7: comparator interventio... | intervention 1: dabigatran with ASA intervention 2: dabigatran with ASA intervention 3: dabigatran with ASA intervention 4: dabigatran with ASA intervention 5: dabigatran with ASA intervention 6: dabigatran with ASA intervention 7: warfarin intervention 8: dabigatran without ASA intervention 9: dabigatran without ASA i... | 38 | Fayetteville | Arkansas | United States | -94.15743 | 36.06258
La Mesa | California | United States | -117.02308 | 32.76783
Pensacola | Florida | United States | -87.21691 | 30.42131
Port Charlotte | Florida | United States | -82.09064 | 26.97617
St. Petersburg | Florida | United States | -82.67927 | 27.77086
Baltimore... | 0 | NCT01227629 | |
[
4
] | 605 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This study will evaluate whether anemia prevention with NeoRecormon has an additional impact on reducing cardiovascular risk over conventional anemia treatment in patients mostly with stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is 2+ years and the target sample size is 500+... | null | Anemia | null | 2 | arm 1: Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months. arm 2: Participants received epoetin beta treatment starting at 2000 IU,... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Participants in the early treatment group immediately started epoetin beta treatment to reach a target Hb level of 13-15 g/dL at the end of the correction phase. intervention 2: Participants in the late treatment Group started epoetin beta treatment once a decline in Hb level to \<10.5 g/dL had occurred... | intervention 1: epoetin beta [NeoRecormon] intervention 2: epoetin beta [NeoRecormon] | 93 | Linz | N/A | Austria | 14.28611 | 48.30639
Sankt Pölten | N/A | Austria | 15.63333 | 48.2
Brussels | N/A | Belgium | 4.34878 | 50.85045
Brussels | N/A | Belgium | 4.34878 | 50.85045
Edegem | N/A | Belgium | 4.44504 | 51.15662
Brno | N/A | Czechia | 16.60796 | 49.19522
Havířov | N/A | Czechia | 18.43688 | 49.77984
Olomo... | 1 | NCT00321919 | |
[
3
] | 67 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | PURPOSE: Phase II trial to study the effectiveness of combining capecitabine and irinotecan in treating patients who have locally advanced, recurrent, or metastatic colorectal cancer. | OBJECTIVES:
Primary:
* Determine the overall objective response rate in patients with locally advanced, locally recurrent, or metastatic colorectal cancer treated with capecitabine and irinotecan.
Secondary:
* Determine the time to treatment failure, time to overall response, duration of overall response, duration ... | Colorectal Cancer | stage III colon cancer stage IV colon cancer stage III rectal cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum | null | 2 | arm 1: Participants will receive capecitabine (Xeloda) 1000 mg/m\^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m\^2 as a 90-minute intravenous (IV) infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment will be administered. At the discret... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Capecitabine intervention 2: Irinotecan | 17 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Loma Linda | California | United States | -117.26115 | 34.04835
Norwich | Connecticut | United States | -72.07591 | 41.52426
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Washington D.C. | District of Columbia | United States | ... | 0 | NCT00022698 |
[
3
] | 52 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study will evaluate T-20 in children. | Children are stratified by age group (3 through 11 years and 12 through 16 years). Samples for HIV-1 genotype and phenotype resistance testing are obtained at screening to aid in the selection of concomitant antiretrovirals. Simultaneous to initiating T-20, all patients begin a "new" optimized antiretroviral regimen ba... | HIV Infections | Anti-HIV Agents pentafuside | null | 0 | null | null | 1 | [
0
] | intervention 1: None | intervention 1: Enfuvirtide | 7 | Los Angeles | California | United States | -118.24368 | 34.05223
Gainesville | Florida | United States | -82.32483 | 29.65163
New York | New York | United States | -74.00597 | 40.71427
New York | New York | United States | -74.00597 | 40.71427
The Bronx | New York | United States | -73.86641 | 40.84985
The Bronx | New ... | 0 | NCT00022763 |
[
4
] | 1,609 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | null | This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individ... | null | Post Menopausal Osteoporosis | null | 4 | arm 1: Participants will receive 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly. Participants will also receive calcium 500 mg /day and vitamin D 400 international units (IU)/day . arm 2: Participants will receive 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg... | [
1,
0,
0,
0
] | 6 | [
0,
0,
0,
0,
7,
7
] | intervention 1: 2.5mg po daily intervention 2: 100mg po monthly on a single day intervention 3: 100mg po monthly over 2 consecutive days intervention 4: 150mg po monthly intervention 5: 500 mg/day intervention 6: 400 IU/day | intervention 1: Ibandronate [Bonviva/Boniva] intervention 2: Ibandronate [Bonviva/Boniva] intervention 3: Ibandronate [Bonviva/Boniva] intervention 4: Ibandronate [Bonviva/Boniva] intervention 5: Calcium intervention 6: Vitamin D | 68 | Irvine | California | United States | -117.82311 | 33.66946
Loma Linda | California | United States | -117.26115 | 34.04835
Los Angeles | California | United States | -118.24368 | 34.05223
Oakland | California | United States | -122.2708 | 37.80437
Rancho Mirage | California | United States | -116.41279 | 33.73974
Lake... | 0 | NCT00048061 | |
[
3
] | 253 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The main purpose of the study is to test whether a possible new drug (called PG-116800) can prevent some of the damage to heart muscle in patients who have had a heart attack. The study will also supply information regarding possible uses of this compound in cardiovascular disease. | Heart attacks cause damage to heart muscle that can weaken the heart and lead to changes in the shape and pumping ability of the heart. These changes can lead to heart failure. An enzyme called metalloproteinase (MMP) plays a role in this damage.
The main purpose of the study is to test whether a possible new drug (ca... | Myocardial Infarction Heart Failure Heart Enlargement | null | 2 | arm 1: PG-116800 tablet (200 mg) taken twice daily for 90 days arm 2: Placebo tablet taken twice daily for 90 days | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 200 mg tablet of PG-116800 (given as PG-530742)twice a day for 90 days intervention 2: placebo tablet, twice a day for 90 days | intervention 1: PG-116800 (given as PG-530742) intervention 2: Placebo tablet | 52 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Merced | California | United States | -120.48297 | 37.30216
Denver | Colorado | United States | -104.9847 | 39.73915
Farmington | Connecticut | United States | -72.83204 | 41.71982
Atlantis | Florida | United States | -80.10088 | 26.5909
Clearwater | Florida... | 0 | NCT00067236 | |
[
4
] | 254 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with chronic shift work sleep disorder (SWSD) by measuring mean sleep latency from the Multiple Sleep Latency Test (MSLT) (20 minu... | null | Excessive Sleepiness Shift Work Sleep Disorder | Excessive Sleepiness Chronic Shift Work Sleep Disorder Chronic SWSD Circadian Rhythm Disorder Shift Worker Cephalon Cephalon, Inc Nuvigil | null | 2 | arm 1: Armodafinil 150 mg/day arm 2: Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked. intervention 2: Matching placebo tablets once daily | intervention 1: Armodafinil 150 mg/day intervention 2: Placebo | 0 | null | 0 | NCT00080288 |
[
3
] | 180 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | A 6-week in-patient and out-patient study to test the effectiveness and safety of a new medication in the treatment of schizophrenia | Study will evaluate the efficacy of a new compound versus placebo in the treatment of patients with schizophrenia (diagnosed by DSM-IV criteria) as measured by reductions from baseline on the total score of the Brief Psychiatric Rating Scale (BPRS) as extracted from the Positive and Negative Syndrome Scale (PANSS). | Schizophrenia | Schizophrenia Latuda Lurasidone | null | 2 | arm 1: 80 mg AM dosing once daily arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 80 mg AM dosing once daily intervention 2: Matching Placebo to 40mg lurasidone tablets | intervention 1: Lurasidone intervention 2: Placebo | 22 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Cerritos | California | United States | -118.06479 | 33.85835
Garden Grove | California | United States | -117.94145 | 33.77391
La Mesa | California | United States | -117.02308 | 32.76783
San Diego... | 0 | NCT00088634 |
[
4
] | 596 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This study is a 24-week multicenter, randomized, double-blind control trial with ursodeoxycholic acid (UDCA) in patients with chronic hepatitis C in Japan. The primary objectives of this study are to verify the superiority of efficacy of UDCA 600 or 900mg/day to that of 150mg/day and the safety of UDCA treatment. | This study is a 24-week multicenter, randomized, double-blind control trial with ursodeoxycholic acid (UDCA) in patients with chronic hepatitis C in Japan. The primary objectives of this study are to verify the superiority of efficacy of UDCA 600 or 900mg/day to that of 150mg/day and the safety of UDCA treatment. The p... | Chronic Hepatitis C | Chronic hepatitis C, Ursodeoxycholic acid | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Ursodeoxycholic acid, 150mg/ day, three times a day at meals intervention 2: Ursodeoxycholic acid, 600mg/ day, three times a day at meals intervention 3: Ursodeoxycholic acid, 900mg/ day, three times a day at meals | intervention 1: Ursodeoxycholic acid 150mg / day intervention 2: Ursodeoxycholic acid 600mg / day intervention 3: Ursodeoxycholic acid 900mg / day | 1 | Hongo, Bunkyo-ku, Tokyo | N/A | Japan | N/A | N/A | 0 | NCT00200343 |
[
3
] | 110 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study will examine the efficacy of topical amethocaine gel (Ametop) in decreasing the pain response in term neonates subjected to intramuscular injection for administration of vitamin K.
Study Hypothesis: We believe that topical amethocaine gel will be superior to placebo in decreasing the pain from intramuscular... | This randomized controlled trial will assess the efficacy of topical amethocaine gel (Ametop) compared with placebo (Eucerin plus) in decreasing the pain response in term neonates subjected to intramuscular injection for administration of vitamin K. Neonatal pain response between groups will be assessed using the Neona... | Pain | Infant,newborn Topical anesthesia Intramuscular injection | null | 2 | arm 1: 1 g of topical amethocaine gel 4% arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 1g, single application intervention 2: 1 g, single application | intervention 1: Eucerin plus intervention 2: Amethocaine gel 4% | 1 | Toronto | Ontario | Canada | -79.39864 | 43.70643 | 0 | NCT00267111 |
[
0
] | 7 | NA | SINGLE_GROUP | 6HEALTH_SERVICES_RESEARCH | 0NONE | true | 0ALL | false | Megestrol Acetate (MA) is a progesterone-like hormone that has been utilized as a birth control agent, chemotherapeutic drug, and more recently, to induce appetite and weight gain in patients malnourished as a result of radiation therapy, chemotherapy, cystic fibrosis, AIDS, or dementia. The mechanism of MA-stimulated ... | null | Adrenal Insufficiency | megestrol acetate adrenal insufficiency adrenal suppression | null | 1 | arm 1: Study subjects will be given 600mg of MA for oral ingestion per day for duration of 8 weeks. They will be monitored every week clinically for the development of adrenal insufficiency by review of symptoms, physical exam, body weight, pulse, and blood pressure. Subjects also will undergo biochemical evaluation of... | [
0
] | 1 | [
0
] | intervention 1: 600 mg by mouth daily | intervention 1: megestrol acetate | 1 | Little Rock | Arkansas | United States | -92.28959 | 34.74648 | 0 | NCT00575029 |
[
3
] | 4 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The development of glucose-sparing strategies able to provide an efficacious ultrafiltration profile represents one of the modern goals of peritoneal dialysis therapy. The study hypothesis is to evaluate the possibility to formulate peritoneal dialysis solutions containing L-carnitine as an osmotic agent to partially r... | null | End-Stage Renal Disease | Peritoneal dialysis L-carnitine | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Instillation of glucose-based (1.5% weight/volume) peritoneal dialysis solution containing L-carnitine (0.25% weight/volume) for the nocturnal exchange. Patients were treated with the experimental peritoneal dialysis solution for 5 days. | intervention 1: L-carnitine | 1 | Chieti | N/A | Italy | 14.16494 | 42.34827 | 0 | NCT00922701 |
[
2
] | 132 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | false | The purpose of this study is to examine the effect of buprenorphine on QT interval corrected for heart rate (QTc) in healthy subjects. | Drugs in this opioid class have been associated with prolonging QT interval/QT interval corrected for heart rate (QTc). | Healthy Volunteers | Healthy subjects Opioid Transdermal | null | 3 | arm 1: Buprenorphine transdermal patches 5, 10, 20, and 2 \* 20 mcg/h. arm 2: Matching placebo transdermal patches 5, 10, 20 and 2 \* 20. arm 3: Moxifloxacin hydrochloride 400 mg tablets | [
0,
2,
1
] | 3 | [
0,
0,
0
] | intervention 1: Buprenorphine transdermal patch 5, 10, 20, and 2 \* 20 mcg/h. intervention 2: Placebo transdermal patch to match BTDS 5, 10, 20, and 2 \* 20. intervention 3: Moxifloxacin 400 mg tablet; 1 tablet taken orally on days 6 and 13 | intervention 1: Buprenorphine transdermal patch intervention 2: Matching placebo transdermal patch intervention 3: Avelox (moxifloxacin hydrochloride) tablet | 1 | Austin | Texas | United States | -97.74306 | 30.26715 | 0 | NCT01148537 |
[
4
] | 507 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Subjects who had previously received GW-1000-02 in a GW study who opted to continue using it in the long-term were monitored for ongoing tolerability and evidence of clinical benefit. | Subjects who had previously participated in a placebo controlled GW clinical study were screened and if eligible began dosing with GW-1000-02. Subjects were reviewed for tolerability and evidence of clinical benefit at weeks two and four and then every eight weeks. Subjects self-titrated to symptom resolution or maximu... | Multiple Sclerosis Spasticity Pain | null | 1 | arm 1: Active treatment | [
0
] | 1 | [
0
] | intervention 1: Contained delta-9-tetrahydrocannabinol (THC) (27 mg/ml) and cannabidiol (CBD) (25 mg/ml) as extract of Cannabis sativa L., with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each 100 μl actuation of the pump action spray delivered 2.7 mg THC and 2.5 mg CBD. A maximum daily ... | intervention 1: GW-1000-02 | 1 | Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 | 0 | NCT01606137 | |
[
2
] | 18 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 2MALE | false | Single centre, double-blind, randomised, placebo-controlled study of two dosage regimens of BIA 2-093 - 1800 mg (Group 1) and 2400 mg (Group 2) - in two groups of healthy male volunteers | Within each group (n=9) 3 volunteers were randomised to receive placebo and the remaining 6 volunteers to receive BIA 2-093. No volunteer was a member of more than one treatment group. In each group, the study consisted of a single-dose period (Phase A) followed by a 7-day multiple-dose period (Phase B). The multiple-d... | Epilepsy | Anticonvulsant | null | 3 | arm 1: 3 tablets of BIA 2-093 600 mg arm 2: 4 tablets of BIA 2-093 600 mg arm 3: placebo tablets | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 3 tablets of BIA 2-093 intervention 2: 4 tablets of BIA 2-093 600 mg intervention 3: placebo tablets | intervention 1: BIA 2-093 - 1800 mg (Group 1) intervention 2: BIA 2-093 - 2400 mg (Group 2) intervention 3: Placebo | 1 | Trofa | Coronado (S.Romão E S. Mamede) | Portugal | -8.5596 | 41.33729 | 0 | NCT01879345 |
[
3
] | 40 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Current therapies for Glioblastoma Multiforme provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of brain tumors.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineopl... | OVERVIEW: This is a single arm, open-label study in which adults (≥ 18 years of age) with newly diagnosed Glioblastoma Multiforme receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in th... | Glioblastoma Multiforme of Brain | adult glioblastoma | null | 1 | arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. | [
0
] | 1 | [
0
] | intervention 1: Adults with a newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).
The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of... | intervention 1: Antineoplaston therapy (Atengenal + Astugenal) | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00003456 |
[
2
] | 45 | RANDOMIZED | SEQUENTIAL | 0TREATMENT | 3TRIPLE | false | null | true | The primary objective was to evaluate the safety and tolerability of denosumab (AMG 162) after a single subcutaneous administration in Japanese postmenopausal women. | null | Osteoporosis | Postmenopausal Denosumab | null | 2 | arm 1: Participants received a single subcutaneous injection of placebo to denosumab on day 1. arm 2: Participants received a single subcutaneous dose of denosumab on day 1. Doses included 0.03, 0.1, 0.3, 1.0, and 3.0 mg/kg. | [
2,
0
] | 2 | [
0,
2
] | intervention 1: Administered by subcutaneous injection intervention 2: Administered by subcutaneous injection | intervention 1: Placebo intervention 2: Denosumab | 0 | null | 0 | NCT03822078 |
[
3
] | 75 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to assess the safety and tolerability of administering SPD503 (Guanfacine hydrochloride) with psychostimulants (amphetamine or methylphenidate) for treatment of ADHD in children and adolescents aged 6-17 | null | Attention Deficit Disorder With Hyperactivity | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Methylphenidate + SPD503 (Guanfacine hydrochloride) intervention 2: Amphetamine + SPD503 | 0 | null | 0 | NCT00151996 | |
[
4
] | 196 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with narcolepsy by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (20-minute version)(average of 4 na... | null | Narcolepsy | Narcolepsy Excessive Sleepiness Cataplexy Sleep Attacks Excessive Sleepiness associated with Narcolepsy Cephalon Cephalon, Inc Nuvigil | null | 3 | arm 1: Armodafinil 250 mg arm 2: Armodafinil 150 mg arm 3: Placebo | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Armodafinil 250 mg once daily in the morning intervention 2: Armodafinil 150 mg once daily in the morning intervention 3: Matching placebo tablets once daily | intervention 1: Armodafinil intervention 2: Armodafinil intervention 3: Placebo | 0 | null | 0 | NCT00078377 |
[
4
] | 116 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | A study to investigate the effects of sublingual cannabis based medicine extracts on neuropathic pain associated with spinal cord injury. | This was a multi-centre, double-blind, randomised, placebo-controlled, parallel-group study to evaluate the efficacy and tolerability of GW-1000-02 in central neuropathic pain associated with spinal cord injury. Patients were screened to determine eligibility and completed a seven to 21 day baseline period. Patients th... | Pain | null | 2 | arm 1: Active treatment. arm 2: Placebo control. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Contained delta-9-tetrahydrocannabinol (THC) (27 mg/ml):cannabidiol (CBD) (25 mg/ml) as extract of Cannabis sativa L., with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg). The maximum permitted dose of study medicat... | intervention 1: GW-1000-02 intervention 2: Placebo | 1 | Middlesex | N/A | United Kingdom | -0.26856 | 51.53174 | 0 | NCT01606202 | |
[
3
] | 9 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The study is planned to be conducted in 2 parts. The first part (open label, multi-center, non-controlled) of the study will estimate a dose that would provide a mycophenolic acid (MPA) exposure in pediatric participant that is comparable to that achieved in adult liver transplant participants receiving the approved do... | null | Pediatric Liver Transplantation | null | 1 | arm 1: Part 1: Participants will receive mycophenolate mofetil. Part 2: Participants will receive mycophenolate mofetil along with cyclosporine and corticosteroids. | [
0
] | 3 | [
0,
0,
0
] | intervention 1: Corticosteroids will be administered as per center practice. The choice of corticosteroid drug will also be based on center practice. intervention 2: Cyclosporine will be administered as per center practice. intervention 3: Part 1: Mycophenolate mofetil will be administered as per center practice. Part ... | intervention 1: Corticosteroids intervention 2: Cyclosporine intervention 3: mycophenolate mofetil | 2 | San Francisco | California | United States | -122.41942 | 37.77493
New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT02630563 |
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