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string
primaryPurpose
class label
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healthyVolunteers
bool
sex
class label
oversightHasDmc
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briefSummary
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string
conditions
string
conditionsKeywords
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numArms
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nctid
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[ 4 ]
185
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative hospitalized adult orthopedic patients every 6 hours for at least 24 hours is to determine the efficacy of Caldolor (IV ibuprofen) compared to placebo for the treatment of post-operative pain by patients self-assessment of pai...
null
Pain
null
2
arm 1: 250 milliliters normal saline as a placebo comparator was administered every 6 hours for a total of five doses over the first 24 hours. Those patients who received the initial five doses could continue to receive additional doses as needed every 6 hours through the 120-hour treatment period. arm 2: 800 mg of int...
[ 2, 0 ]
2
[ 0, 10 ]
intervention 1: 800 milligrams intravenous intervention 2: Placebo comparator
intervention 1: Caldolor intervention 2: Normal Saline
9
Mobile | Alabama | United States | -88.04305 | 30.69436 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Arcadia | California | United States | -118.03534 | 34.13973 Atlanta | Georgia | United States | -84.38798 | 33.749 Houston | Texas | United States | -95.36327 | 29.76328 Houston | Texas | United States...
0
NCT00470600
[ 3 ]
1
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine what dose of bortezomib in combination with tositumomab I-131 is tolerable whether bortezomib and Tositumomab I-131 are effective in the treatment of relapsed or refractory non-hodgkin's lymphoma (NHL). Both agents are effective in treating relapsed and refractory NHL. Administ...
null
Follicular Lymphoma
Non-Hodgkin's Lymphoma Follicular Non-Hodgkin's Lymphoma Lymphoma
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: Bortezomib and Tositumomab I-131
1
Chicago | Illinois | United States | -87.65005 | 41.85003
0
NCT00479167
[ 0 ]
136
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
1FEMALE
false
Epidural chloroprocaine is often used in obstetrical anesthesia because of its fast onset and short duration. These properties make it an ideal drug to use for epidural anesthesia in patients undergoing postpartum tubal ligation. When epidural morphine is given after chloroprocaine, there is a decreased efficacy of ana...
Women undergoing post partum tubal ligation with an epidural in-situ will be randomly double blindedly selected into one of three groups for pain control. The groups are epidural 1) epidural morphine-chloroprocaine 2) epidural chloroprocaine-morphine 3) epidural morphine-lidocaine. Groups 1 and 3 will receive morphine ...
Labor Analgesia, Epidural
analgesia tubal ligation chloroprocaine
null
3
arm 1: morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision arm 2: saline will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level;morphine will be administered at skin incision arm...
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 3mg of preservative free morphine will be administered epidurally 30 min prior to epidural anesthesia. Epidural 3% 2CP will be used to achieve a T4 dermatomal level for surgical anesthesia for PPTL. 6ml of epidural saline will be administered at skin incision intervention 2: 6ml of saline will be admini...
intervention 1: Morphine-CP-saline (MCS) intervention 2: saline-2CP-morphine (SCM) intervention 3: saline-lidocaine-morphine (SLM)
1
Chicago | Illinois | United States | -87.65005 | 41.85003
0
NCT00487084
[ 4 ]
442
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
null
Diabetes Mellitus Type 2
diabetes type 2
null
2
arm 1: Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks. arm 2: Detemir: Patient specific dose administered subcutaneously once or twice daily x 24 weeks.
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks. intervention 2: Patient specific dose administered subcutaneously once or twice daily x 24 weeks.
intervention 1: Insulin Lispro Protamine Suspension intervention 2: Detemir
56
Hueytown | Alabama | United States | -86.99666 | 33.45122 Litchfield Park | Arizona | United States | -112.35794 | 33.49337 Phoenix | Arizona | United States | -112.07404 | 33.44838 Buena Park | California | United States | -117.99812 | 33.86751 Fountain Valley | California | United States | -117.95367 | 33.70918 Los A...
0
NCT00494013
[ 3 ]
43
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
2MALE
false
To assess the viral load response, safety, tolerability and pharmacokinetics of multiple oral doses of PF 00232798 in HIV-positive patient volunteers.
null
HIV
Treatment Experienced Treatment Naive
null
6
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
[ 1, 1, 1, 1, 1, 1 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: Solution, 20 mg. once daily, 10 days intervention 2: Solution, 150 mg. once daily, 10 days intervention 3: Solution, 5 mg. once daily, 10 days intervention 4: Solution, 40 mg. once daily, 10 days intervention 5: Solution, 300 mg. once daily, 10 days intervention 6: Solution, 400 mg. once daily, 10 days
intervention 1: PF-00232798 intervention 2: PF-00232798 intervention 3: PF-00232798 intervention 4: PF-00232798 intervention 5: PF-00232798 intervention 6: PF-00232798
2
Cologne | N/A | Germany | 6.95 | 50.93333 Frankfurt am Main | N/A | Germany | 8.68417 | 50.11552
0
NCT00495677
[ 3 ]
86
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
2MALE
false
The purpose of this study is to determine whether treatment with Zactima (vandetanib) in combination with Docetaxel and Prednisolone is more effective than the standard Docetaxel and Prednisolone alone for prostate cancer, in patients with Hormone refractory prostate cancer who have not previously received chemotherapy...
null
Prostate Cancer Metastatic Hormone Refractory
prostate cancer zactima vandetanib metastatic
null
0
null
null
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: Zactima (vandetanib) intervention 2: Docetaxel intervention 3: Prednisolone
11
Rio de Janeiro | N/A | Brazil | -43.18223 | -22.90642 São Paulo | N/A | Brazil | -46.63611 | -23.5475 Hamburg | N/A | Germany | 9.99302 | 53.55073 Hanover | N/A | Germany | 9.73322 | 52.37052 Kassel | N/A | Germany | 9.5 | 51.31667 Tübingen | N/A | Germany | 9.05222 | 48.52266 Budapest | N/A | Hungary | 19.04045 | 47.4...
0
NCT00498797
[ 4 ]
155
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The primary objective of this study is to assess the immunogenic potential of the liquid formulation of omalizumab administered over a period of 6 months in moderate to severe persistent allergic asthma patients 12 years of age or older, with no previous exposure to the drug (omalizumab naïve patients). The secondary o...
null
Asthma
Asthma omalizumab safety allergic asthma adolescents
null
0
null
null
1
[ 0 ]
intervention 1: The liquid formulation of omalizumab was packaged in a pre-filled safety syringe containing either 75 mg (0.5ml) or 150 mg (1.0 ml) of drug. The syringes were clearly marked so that the health care provider could differentiate between the 75 mg or 150 mg syringe.
intervention 1: omalizumab
31
Scottsdale | Arizona | United States | -111.89903 | 33.50921 Palmdale | California | United States | -118.11646 | 34.57943 San Diego | California | United States | -117.16472 | 32.71571 Stockton | California | United States | -121.29078 | 37.9577 Centennial | Colorado | United States | -104.87692 | 39.57916 Largo | Flo...
0
NCT00500539
[ 0 ]
2
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Primary Objective: 1\. To determine whether rhG-CSF treatment will increase the frequency of donor-derived cells contributing to repair of damaged epithelial/endothelial or solid organ-specific tissue caused by graft-versus-host disease (GVHD) in patients who underwent sex-mismatched stem cell transplantation. Second...
It has been found that cells circulating in the blood are capable of forming cells lining the oral cavity, skin cells, and/or cells of various organs. RhG-CSF is used to support cell recovery after stem cell transplantation and is commercially available. Before treatment starts, participants will have at least one (an...
Graft-Versus-Host Disease
Graft-Versus-Host Disease Stem Cell Transplantation Tissue Repair Organ-Specific Tissue Damage Filgrastim RhG-CSF
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 5 mg/kg ID Once Daily x 1 Week
intervention 1: Filgrastim
1
Houston | Texas | United States | -95.36327 | 29.76328
0
NCT00501228
[ 3 ]
80
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
true
0ALL
false
This study was intended to assess the safety, efficacy, and response to treatment using the American College of Rheumatology (ACR) criteria of 20% improvement in symptoms (ACR20) and to investigate a potential biomarker profile in adult patients with established rheumatoid arthritis
null
Rheumatoid Arthritis
Rheumatoid Arthritis
null
2
arm 1: Healthy Volunteers: Single administration of 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1. Rheumatoid Arthritis (RA) Patients: Dose of 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43. arm 2: Healthy Volunteers: Single administration of 600 mg of Placebo Intravenous (IV) ...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: The ACZ885 was supplied in 6 mL colorless glass vials each containing nominally 150 mg ACZ885 (with 20% overfill). The vials were kept at 2-8°C. At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered. intervention 2: Matching placebo of ACZ885 was ...
intervention 1: ACZ885 (investigational) intervention 2: Placebo
4
Moscow | N/A | Russia | 37.61556 | 55.75222 Barcelona | N/A | Spain | 2.15899 | 41.38879 Bern | N/A | Switzerland | 7.44744 | 46.94809 Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384
0
NCT00504595
[ 3 ]
520
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
1FEMALE
null
This is a Phase 2, interventional, prospective, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in infertile women who are undergoing an assisted reproductive technology (ART) procedure (In vitro fertilizati...
Infertile women who are candidates for ART will be prospectively screened for enrollment at 24 clinical trial sites in the United States and Argentina. Enrolled subjects will start treatment using oral contraceptives (OCP) and will then receive a Gonadotropin releasing hormone (GnRH)-agonist (leuprolide acetate) for pi...
Infertility
Assisted reproductive technology, follicle stimulating hormone
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 0, 0, 1 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 50 mcg will be administered subcutaneously on Stimulation Day 1 (S1). Duration of treatment cycle will be up to adequate follicular response or maximum of 21 days. intervention 2: Single ...
intervention 1: AS900672-Enriched 50 microgram (mcg) intervention 2: AS900672-Enriched 100 mcg intervention 3: AS900672-Enriched 150 mcg intervention 4: Follitropin alfa 150 international unit (IU) intervention 5: Recombinant human chorionic gonadotropin (r-hCG)
1
Rockland | Massachusetts | United States | -70.91616 | 42.13066
0
NCT00505752
[ 2 ]
4
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
Primary Objective: To evaluate the impact of postoperative exogenous nocturnal melatonin supplementation on the early regulation of the sleep-wake cycle and its clinical impact (subjective improvement of the quality of sleep and reduction of cardiopulmonary events) during the first postoperative week following anesthe...
Melatonin is produced by a small gland in the brain called the pineal gland. During times of stress, use of certain medications, and increasing age, melatonin production may be disrupted or weakened. This may cause sleep disturbance. Many of the drugs used for pain, anesthesia, or cancer treatment may affect the body's...
Breast Cancer
Breast Cancer Sleep Melatonin Placebo Survey Postoperative Srejic Sleep SAT Survey
null
2
arm 1: 0.15 mg/kg capsules by mouth daily arm 2: Starch capsules by mouth daily
[ 0, 2 ]
3
[ 0, 0, 5 ]
intervention 1: 0.15 mg/kg by mouth (PO) Daily intervention 2: Two, three, or four starch tablet or capsules before bed intervention 3: Sleep study surveys, two per day completed each evening, lasting 10 minutes
intervention 1: Melatonin intervention 2: Placebo intervention 3: Questionnaire
1
Houston | Texas | United States | -95.36327 | 29.76328
0
NCT00506064
[ 4 ]
40
null
PARALLEL
0TREATMENT
null
false
0ALL
null
The objective of this study is to compare the efficacy and safety of Tipranavir/ritonavir (TPV/r, 500mg/200mg twice daily) to the safety and efficacy of Darunavir/ritonavir (DRV/r 600 mg /100 mg twice daily) in combination with investigator selected optimised background regimens in patients who are three-class (Nucleos...
null
HIV Infections
null
0
null
null
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: Tipranavir intervention 2: Darunavir intervention 3: Ritonavir
54
Beverly Hills | California | United States | -118.40036 | 34.07362 Fort Lauderdale | Florida | United States | -80.14338 | 26.12231 Miami | Florida | United States | -80.19366 | 25.77427 Miami | Florida | United States | -80.19366 | 25.77427 Tampa | Florida | United States | -82.45843 | 27.94752 Charlotte | North Carol...
0
NCT00517192
[ 2 ]
40
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to investigate the effectiveness, safety, and tolerability of MK7009 in patients infected with Hepatitis C
null
Hepatitis C
null
8
arm 1: 25 mg b.i.d. MK7009 arm 2: 75 mg b.i.d. MK7009 arm 3: 250 mg b.i.d. MK7009 arm 4: 500 mg b.i.d. MK7009 arm 5: 700 mg b.i.d. MK7009 arm 6: 125 mg q.d. MK7009 arm 7: 600 mg q.d. MK7009 arm 8: Placebo
[ 0, 0, 0, 0, 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8. intervention 2: MK7009 Placebo
intervention 1: Comparator: MK7009 intervention 2: Comparator: Placebo
0
null
0
NCT00518622
[ 3 ]
37
RANDOMIZED
FACTORIAL
4SUPPORTIVE_CARE
0NONE
false
0ALL
true
Cachexia is a presentation of a chronic manifestation of acute metabolic stress, a hypercatabolic nutritional state in which the normal fat and protein sparing mechanisms are not functioning and increased nutrition is not utilized. To switch the nutritional system from a hypercatabolic to a normal nutritional state, t...
The objective of this trial is to evaluate the safety and dose tolerability of VT-122 regimen and to evaluate the efficacy of VT-122 regimen This trial is to be conducted on patients who have a diagnosis of Stage IV NSCLC, are not on chemotherapy, have lost 5% of their body weight in the previous 2 months and are deem...
Cachexia
NSCLC anorexia cachexia grip strength lean body mass
null
3
arm 1: Supportive care only arm 2: VT-122 (dose of etodolac: 400 mg/day) + supportive care arm 3: VT-122 (dose of etodolac: 800 mg/day) + supportive care
[ 4, 1, 1 ]
2
[ 0, 0 ]
intervention 1: VT-122 low dose, dose escalated intervention 2: VT-122 high dose, dose escalated
intervention 1: VT-122 low dose intervention 2: VT-122 high dose
8
Waco | Texas | United States | -97.14667 | 31.54933 Bangalore | N/A | India | 77.59369 | 12.97194 Hyderabaad | N/A | India | N/A | N/A Kolkata | N/A | India | 88.36304 | 22.56263 Nashik | N/A | India | 73.79096 | 19.99727 New Delhi | N/A | India | 77.2148 | 28.62137 New Delhi | N/A | India | 77.2148 | 28.62137 Pune | N...
0
NCT00527319
[ 3 ]
1
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Primary Objectives: 1. To examine the effect of celecoxib treatment on histological response, markers of proliferation (Ki-67), and apoptosis. Secondary endpoints include time to second primary or recurrence and survival. 2. To examine the toxicity associated with celecoxib administration in patients with previously t...
In order to enroll in this trial, you must also be enrolled in Protocol 2003-0424. The study procedures and tests that are part of this study are the same procedures and tests that are part of Protocol 2003-0424. Even though a procedure or test is described in both this consent and the consent for Protocol 2003-0424, y...
Head and Neck Cancer Lung Cancer
Head and Neck Cancer Lung Cancer Non-Small Cell Lung Cancer Celecoxib Celebrex
null
2
arm 1: 600 mg orally (PO) daily arm 2: None
[ 0, 4 ]
1
[ 0 ]
intervention 1: 600 mg by mouth daily for a total of 12 months.
intervention 1: Celecoxib
1
Houston | Texas | United States | -95.36327 | 29.76328
0
NCT00527982
[ 3 ]
72
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition. Whether duloxetine once daily orally is tolerated and safe, in children (aged 7 through 11 years) and adolescents (aged 12 through 17 years) with Major Depressi...
null
Major Depressive Disorder
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is \>40 kg, initial dose is 30 mg, then titrated up.
intervention 1: duloxetine
22
Dothan | Alabama | United States | -85.39049 | 31.22323 Chandler | Arizona | United States | -111.84125 | 33.30616 El Centro | California | United States | -115.56305 | 32.792 Gainesville | Florida | United States | -82.32483 | 29.65163 Miami | Florida | United States | -80.19366 | 25.77427 South Miami | Florida | Unit...
0
NCT00529789
[ 3 ]
66
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to determine whether PF-03654746 is effective in the treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD). This will be a randomized, double-blind, crossover study in which adults with ADHD will receive 3 weeks of treatment with PF-03654746, either a low dose (1 mg), or flexib...
null
Attention Deficit Hyperactivity Disorder
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 2, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Dosage Form: 0.5 mg capsules of PF-03654746 Dosage: 0.5 mg QD for Days 1-7, then 1.0 mg QD Days 8-14, then 2.0 mg QD Days 15-21 intervention 2: Dosage Form: matching placebo capsules Dosage: Subjects will take two placebo capsules each morning throughout the 3 week double-blind treatment placebo treatme...
intervention 1: PF-03654746 intervention 2: Placebo capsules intervention 3: PF-03654746
7
Lafayette | California | United States | -122.11802 | 37.88576 Los Alamitos | California | United States | -118.07256 | 33.80307 Newport Beach | California | United States | -117.92895 | 33.61891 Chicago | Illinois | United States | -87.65005 | 41.85003 Cambridge | Massachusetts | United States | -71.10561 | 42.3751 Ne...
0
NCT00531752
[ 4 ]
409
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
This study is being carried out to see if extended release quetiapine fumarate (Seroquel®XL) when added to standard selective serotonin reuptake inhibitor (SSRI) / serotonin-norepinephrine reuptake inhibitor (SNRI) therapy is effective and safe for the treatment of Generalized Anxiety Disorder in patients with partial ...
null
Anxiety Anxiety Disorders Anxiety Neuroses Anxiety States
Generalized anxiety disorders anxiety adjunct treatment in anxiety anxiety disorder partial or non-responder in anxiety
null
2
arm 1: Adjunctive Placebo Seroquel XR to anxiety treatment arm 2: Adjunctive Seroquel XR to anxiety treatment
[ 5, 0 ]
2
[ 0, 0 ]
intervention 1: oral intervention 2: oral
intervention 1: Placebo intervention 2: quetiapine fumarate XR
53
Birmingham | Alabama | United States | -86.80249 | 33.52066 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Beverly Hills | California | United States | -118.40036 | 34.07362 Encino | California | United States | -118.50119 | 34.15917 Fresno | California | United States | -119.77237 | 36.74773 La Mesa | C...
0
NCT00534599
[ 5 ]
106
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
This study will evaluate hyperemia and ocular surface tolerability in patients on prostaglandin analogues
null
Open Angle Glaucoma Ocular Hypertension
null
3
arm 1: bimatoprost 0.03% arm 2: travoprost 0.004% arm 3: latanoprost 0.005%
[ 0, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: bimatoprost 0.03%, 1 drop nightly for 3 months intervention 2: travoprost 0.004% eye drops, 1 drop nightly for 3 months intervention 3: latanoprost 0.005%, 1 drop nightly for 3 months
intervention 1: Bimatoprost 0.03% intervention 2: travoprost 0.004% intervention 3: latanoprost 0.005% eye drops
1
San Diego | California | United States | -117.16472 | 32.71571
0
NCT00539526
[ 4 ]
531
null
PARALLEL
0TREATMENT
null
false
0ALL
null
To demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to amlodipine 5 mg alone in patients with essential hypertension and inadequately controlled with amlodipine 5 mg monotherapy.
null
Hypertension
null
0
null
null
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: telmisartan+amlodipine intervention 2: amlodipine
41
Azumino, Nagano | N/A | Japan | N/A | N/A Higashiosaka, Osaka | N/A | Japan | N/A | N/A Itabashi-ku, Tokyo | N/A | Japan | 139.69171 | 35.6895 Kashihara, Osaka | N/A | Japan | N/A | N/A Kitaazumi-gun, Nagano | N/A | Japan | 138.18333 | 36.65 Kiyose, Tokyo | N/A | Japan | N/A | N/A Kobe, Hyogo | N/A | Japan | N/A | N/A ...
0
NCT00558064
[ 4 ]
1,098
null
PARALLEL
0TREATMENT
null
false
0ALL
null
The primary objectives of this trial are (a) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is superior in reducing blood pressure at eight weeks compared with A5 (b) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is not inferior in...
null
Hypertension
null
0
null
null
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: fixed dose combination of telmisartan+amlodipine intervention 2: amlodipine
129
Aywaille | N/A | Belgium | 5.67684 | 50.47411 Brussels | N/A | Belgium | 4.34878 | 50.85045 Gozée | N/A | Belgium | 4.35273 | 50.33461 Linkebeek | N/A | Belgium | 4.33688 | 50.76781 Mol | N/A | Belgium | 5.11662 | 51.19188 Natoye | N/A | Belgium | 5.058 | 50.34294 Tavier | N/A | Belgium | 5.47063 | 50.49634 Tienen-Kumt...
0
NCT00558428
[ 4 ]
756
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The objective of this study is to evaluate the safety and efficacy of various doses of VI-0521 compared to both placebo, and the single-agent components that comprise each combination dose. This study will provide confirmatory data to demonstrate that doses of VI-0521 have efficacy that is greater than placebo and each...
null
Obesity
null
7
arm 1: VI-0521; high dose phentermine/topiramate arm 2: VI-0521; mid dose phentermine/topiramate arm 3: mid dose topiramate arm 4: high dose topiramate arm 5: mid dose phentermine arm 6: high dose phentermine arm 7: None
[ 0, 0, 1, 1, 1, 1, 2 ]
7
[ 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: phentermine 15 mg and topiramate 92 mg, po once daily intervention 2: phentermine 7.5 mg and topiramate 46 mg, po once daily intervention 3: topiramate 46 mg, po once daily intervention 4: topiramate 92 mg, po once daily intervention 5: phentermine 7.5 mg, po once daily intervention 6: phentermine 15 mg...
intervention 1: VI-0521 intervention 2: VI-0521 intervention 3: topiramate intervention 4: topiramate intervention 5: phentermine intervention 6: phentermine intervention 7: VI-0521
2
Durham | North Carolina | United States | -78.89862 | 35.99403 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
0
NCT00563368
[ 4 ]
244
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
0ALL
false
This research study will look at the pain relieving ability and safety of using repeated doses of intravenous (into the vein \[IV\]) acetaminophen in the treatment of moderate postoperative pain after planned or elective abdominal laparoscopic surgery, such as a laparoscopic abdominal hysterectomy or laparoscopic chole...
To assess the analgesic efficacy of repeated doses of intravenous acetaminophen (IV APAP) versus Placebo in the treatment of moderate postoperative pain after abdominal laparoscopic surgery.
Pain
Abdominal Laparoscopic Surgery
null
4
arm 1: IV Placebo 100 ml dosed every every 6 hours for 24 hours (4 doses total). arm 2: IV Placebo 65 ml dosed every every 4 hours for 24 hours (6 doses total). arm 3: IV Acetaminophen 1 gm dosed every every 6 hours for 24 hours (4 doses total). arm 4: IV Acetaminophen 650 mg dosed every every 4 hours for 24 hours (6 d...
[ 2, 2, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: IV, every 6 hours for 24 hours (4 doses total) intervention 2: IV, every 4 hours for 24 hours (6 doses total) intervention 3: IV, every 6 hours for 24 hours (4 doses total) intervention 4: IV, every 4 hours for 24 hours (6 doses total)
intervention 1: IV Placebo intervention 2: IV Placebo intervention 3: IV Acetaminophen intervention 4: IV Acetaminophen
17
Sheffield | Alabama | United States | -87.69864 | 34.76509 Phoenix | Arizona | United States | -112.07404 | 33.44838 Arcadia | California | United States | -118.03534 | 34.13973 Glendale | California | United States | -118.25508 | 34.14251 Laguna Hills | California | United States | -117.71283 | 33.61252 Pasadena | Cal...
0
NCT00564486
[ 3 ]
8
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
false
This 7 week, open-label pilot clinical trial will examine the safety and tolerability of modafinil up to 400mg/day as a potential treatment to reduce methamphetamine use in methamphetamine-dependent volunteers.
null
Methamphetamine Dependence
null
0
null
null
1
[ 0 ]
intervention 1: subjects attend clinic for the first week in order to receive meds; oral, 200mg/day doses for three days for initiation doses; increased to oral 400mg/day for the remainder of the trial (weeks 2-6); washout period during week 7
intervention 1: Modafinil
1
Little Rock | Arkansas | United States | -92.28959 | 34.74648
0
NCT00569374
[ 3 ]
154
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
null
This study will evaluate the safety and efficacy of QVA149 in patients with moderate to severe COPD.
null
Chronic Obstructive Pulmonary Disease (COPD)
QVA, Indacaterol, Glycopyrrolate, Concept1, COPD, cross over study, safety and efficacy, trough FEV1
null
4
arm 1: One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days. arm 2: Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days. arm 3: One capsule indacaterol 300 μg + one placebo capsule inhaled o...
[ 0, 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Inhalation capsule indacaterol/glycopyrrolate 300/50 μg inhaled once daily via a single dose dry powder inhaler for 7 days. intervention 2: Inhalation capsule indacaterol supplied as 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days. intervention 3: Placebo inhalation ca...
intervention 1: indacaterol/glycopyrrolate intervention 2: indacaterol intervention 3: placebo
22
St Louis | Missouri | United States | -90.19789 | 38.62727 Charlotte | North Carolina | United States | -80.84313 | 35.22709 Raleigh | North Carolina | United States | -78.63861 | 35.7721 Antwerp | N/A | Belgium | 4.40026 | 51.22047 Ghent | N/A | Belgium | 3.71667 | 51.05 Jambes | N/A | Belgium | 4.87166 | 50.45636 San...
0
NCT00570778
[ 5 ]
11
NA
SINGLE_GROUP
null
0NONE
false
0ALL
false
The goals of the study are to evaluate the feasibility of using daptomycin as a prophylactic antimicrobial agent in patients undergoing cardiac surgery, to determine the rates of surgical site infection, and to evaluate the occurrence of adverse events.
null
Antimicrobial Prophylaxis
MRSA Increased risk for infection
null
1
arm 1: Daptomycin as a single preoperative dose within 30 minutes prior to surgery Dosage: if creatinine clearance ≥ 30 ml/min: 6 mg/kg IV
[ 0 ]
1
[ 0 ]
intervention 1: daptomycin 6 mg/kg IV given during induction phase as a one-time prophylactic dose for patients undergoing cardiac valve replacement and coronary artery bypass grafting (CABG) who are at increased risk for infection due to methicillin-resistant Staphylococcus aureus (MRSA)
intervention 1: daptomycin 6 mg/kg IV
1
Durham | North Carolina | United States | -78.89862 | 35.99403
0
NCT00572260
[ 3 ]
6
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
true
The purpose of this study is to find out what effects, good and bad, the combination of docetaxel with CG1940/CG8711 (immunotherapy drugs) have on destroying prostate cancer before removal the prostate (prostatectomy).
null
Prostate Cancer
null
0
null
null
2
[ 0, 2 ]
intervention 1: Docetaxel 75mg/m2 will be given intravenously every 3 weeks for four cycles. intervention 2: Immunotherapy allogeneic GM-CSF secreting cellular vaccine
intervention 1: Docetaxel intervention 2: CG1940/CG8711
1
Seattle | Washington | United States | -122.33207 | 47.60621
0
NCT00577356
[ 3 ]
12
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This study is being done to see if we can improve the response of Interleukin-2 by adding Zoledronic acid. The effectiveness of the combination of drugs in kidney cancer is unknown and will be investigated in this study. In particular, this study will evaluate the effect of this combination on kidney cancer and will al...
The purpose of this research is to evaluate the antitumor response of low-dose Interleukin-2 in combination with Zoledronic acid on subjects with previously untreated, unresectable metastatic renal cell carcinoma. Also, the study will assess the tolerability, safety, pharmacodynamic effects, and immunologic effects of ...
Kidney Cancer
Renal Cell Cancer Metastatic
null
1
arm 1: Interleukin-2 subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles in combination with Zoledronic acid IV on day 1 of every 4 week (28 days) cycle.
[ 0 ]
2
[ 0, 0 ]
intervention 1: Interleukin-2 will be given at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles. intervention 2: Zoledronic acid will be given on day 1 intravenously over 15 or 30 minutes starting at 400mcg. If no significant increase in gamma delta-...
intervention 1: IL2 intervention 2: Zoledronic acid
1
Madison | Wisconsin | United States | -89.40123 | 43.07305
0
NCT00582790
[ 3 ]
64
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
true
0ALL
false
This study will compare the effect of prochlorperazine and ondansetron for the treatment of nausea and vomiting in the emergency department.
Nausea and vomiting can be common symptoms in the emergency department (ED). Antiemetics, agents to treat nausea and vomiting, include phenothiazine derivatives, prokinetic agents, and 5-HT3 antagonists. There have been limited studies on the use of these agents in the ED, and no direct comparisons to 5-HT3 antagonists...
Nausea and Vomiting
null
2
arm 1: Patients receiving Prochlorperazine 10mg IV arm 2: Patient receiving Ondansetron 4mg IV
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Patients receiving Prochlorperazine intervention 2: Patients receiving Ondansetron
intervention 1: Prochlorperazine intervention 2: Ondansetron
2
Atlanta | Georgia | United States | -84.38798 | 33.749 Atlanta | Georgia | United States | -84.38798 | 33.749
0
NCT00590317
[ 3 ]
150
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
This multicenter study will be divided into 2 phases. The first phase will be an open label, dose-escalation phase, while the second will be a blinded, randomized, vehicle-controlled, parallel-group, dose-response phase. The second phase will only start if the first phase succeeds in establishing well tolerated dose(s)...
For the second part: All patients will receive 4 PDT sessions 2 weeks apart using a light dose of 37 J/cm2. One treatment group will receive vehicle cream, while the other 2 groups will receive MAL cream with a concentration of 40 mg/g and 80 mg/g, respectively. The MAL and vehicle cream will be applied in a thin layer...
Acne Vulgaris
null
3
arm 1: PDT using MAL concentration A arm 2: PDT using MAL concentration B arm 3: PDT using Placebo cream
[ 0, 0, 2 ]
1
[ 0 ]
intervention 1: Cream application followed by illumination with red light
intervention 1: Methyl aminolevulinate (MAL) PDT
14
San Diego | California | United States | -117.16472 | 32.71571 Vallejo | California | United States | -122.25664 | 38.10409 Naperville | Illinois | United States | -88.14729 | 41.78586 Clinton Twp | Michigan | United States | N/A | N/A Albuquerque | New Mexico | United States | -106.65114 | 35.08449 Rochester | New Yor...
0
NCT00594425
[ 4 ]
20
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
This randomized, double-blind, parallel-group, controlled, multi-center clinical trial of 6 months duration is designed to assess the efficacy, tolerability and safety of PN400 versus diclofenac/misoprostol in subjects at high risk for developing NSAID-associated gastric ulcers. Approximately 100 sites will participate...
To determine the incidence of gastric ulcers following administration of PN 400 in a high risk population over six months. Diclofenac/misoprostol will be used as a positive control. Secondary: * To determine the incidence of duodenal ulcers during treatment with PN 400 and diclofenac/misoprostol in a high risk popula...
Gastric Ulcer
NSAID Gastric Ulcer High risk Arthrotec Vimovo
null
2
arm 1: PN 400 (esomeprazole/naproxen) dosed twice daily arm 2: diclofenac 75mg/misoprostol 200 mcg dosed twice daily
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: PN400 tablet (500 mg delayed-release naproxen/20 mg immediate-release esomeprazole) given by mouth twice daily (bid). intervention 2: Over-encapsulated ARTHROTEC® 75 (75 mg diclofenac sodium/200 mcg misoprostol) capsules given by mouth bid.
intervention 1: PN400 (VIMOVO) intervention 2: Diclofenac/Misoprostol
1
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
0
NCT00594854
[ 3 ]
1
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The primary purpose of this study is to evaluate the safety and effectiveness of Ammonul® in subjects who become hospitalized with Grade 3 or 4 hepatic encephalopathy (HE).
Hepatic encephalopathy (HE) is a reversible neuropsychiatric syndrome seen in patients with liver disease. The pathogenesis of HE is incompletely understood, but several pieces of evidence identify ammonia as a key factor in the development of HE. The liver normally detoxifies ammonia produced in the gastrointestinal t...
Hepatic Encephalopathy
Ammonul® sodium phenylacetate and sodium benzoate hepatic encephalopathy Grade 3 or 4 Hepatic Encephalopathy
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours) intervention 2: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the ...
intervention 1: sodium phenylacetate and sodium benzoate injection 10% / 10% intervention 2: sodium phenylacetate and sodium benzoate injection 10% / 10% intervention 3: placebo solution (10% dextrose)
3
Fresno | California | United States | -119.77237 | 36.74773 Loma Linda | California | United States | -117.26115 | 34.04835 Odessa | Texas | United States | -102.36764 | 31.84568
0
NCT00597909
[ 3 ]
614
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This study is designed to determine if the investigational drug is effective and safe in individuals with asthma
null
Asthma
dose ranging placebo asthma safety efficacy pharmacokinetics
null
2
arm 1: Placebo Multi dose dry powder inhlaer arm 2: GW642444M
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: GW642444M intervention 2: Placebo mulit-dose dry powder inhaler
intervention 1: GW642444M intervention 2: Placebo
89
Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Fresno | California | United States | -119.77237 | 36.74773 Huntington Beach | California | United States | -117.99923 | 33.6603 Long Beach | California | United States | -118.18923 | 33.76696 Long Beach ...
0
NCT00600171
[ 3 ]
140
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to determine the effectiveness and safety, over 3 months, of 4 dose regimens of CP-690,550, combined with methotrexate, for the treatment with active rheumatoid arthritis.
null
Arthritis, Rheumatoid
Phase II MTX add-on study in Japan
null
5
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
[ 2, 0, 0, 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: 0 mg BID, 3 blinded tablets administered BID for 12 weeks intervention 2: 10 mg BID, 3 blinded tablets administered BID for 12 weeks intervention 3: 1 mg BID, 3 blinded tablets administered BID for 12 weeks intervention 4: 3 mg BID, 3 blinded tablets administered BID for 12 weeks intervention 5: 5 mg BI...
intervention 1: Placebo intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: CP-690,550 intervention 5: CP-690,550
18
Chiba | Chiba | Japan | 140.11667 | 35.6 Fukuoka | Fukuoka | Japan | 130.41667 | 33.6 Hitachi-shi | Ibaraki | Japan | N/A | N/A Sagamihara | Kanagawa | Japan | 139.24167 | 35.56707 Yahatanishi-ku | Kitakyusyu | Japan | N/A | N/A Koushi | Kumamoto | Japan | N/A | N/A Sendai | Miyagi | Japan | 140.86667 | 38.26667 Niigat...
0
NCT00603512
[ 5 ]
83
RANDOMIZED
PARALLEL
6HEALTH_SERVICES_RESEARCH
2DOUBLE
true
1FEMALE
false
This study will evaluate the effect of antidepressants on sex hormone levels in women and if the potential changes in sex hormone levels are related to sexual side effects.
Depression is a leading cause of disability in women, with women being two times more likely than men to develop depression. Depression affects a person's body, thoughts, mood, and behavior, often making normal day-to-day functioning difficult. Fortunately, depression is a condition that is highly treatable with one or...
Healthy
Gonadal Steroid Hormones Healthy Volunteers Antidepressant Side Effects Fluoxetine Bupropion Prolactin Testosterone Estradiol Progesterone Sexual Function Serotonin Reuptake Inhibitors 17-OH Pregnenolone
null
2
arm 1: Participants will receive treatment with fluoxetine for 2 months arm 2: Participants will receive treatment with bupropion for 2 months
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Participants will begin taking 10 mg of fluoxetine, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 20 mg of fluoxetine once a day after 7 days, to be maintained until the luteal phase (start of ovulation) of menstrual cycle 3. If side ...
intervention 1: Fluoxetine intervention 2: Bupropion
0
null
0
NCT00611975
[ 3 ]
6
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this research study is to see if HIV that persists despite current antiviral therapy can be targeted by new treatments. We will see if adding Raltegravir (MK-0518) and Valproic acid (VPA) to current ART can decrease the amount of latent HIV.
The purpose of this research study is to see if HIV that persists despite current antiviral therapy can be targeted by new treatments. Eradicating this hidden, persistent virus (which we will call "latent HIV") may some day allow HIV to be eliminated from an infected person. Recently it has been discovered that a class...
HIV Infections
latent HIV resting CD4+ T cell valproic acid (VPA) Raltegravir (MK-0518) intensification HIV replication treatment experienced
null
1
arm 1: raltegravir 400mg po BID; valproic acid 1000mg - 2000mg daily
[ 0 ]
1
[ 0 ]
intervention 1: raltegravir 400mg po BID; valproic acid 1000mg - 2000mg daily
intervention 1: Raltegravir; valproic acid
1
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
0
NCT00614458
[ 0 ]
115
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
true
0ALL
true
Chronic abdominal pain (CAP) is an extremely pervasive childhood condition and, like IBS in adults, it is one of the functional bowel disorders without a clear framework of understanding or an effective treatment. However, new research suggests that small intestinal bacterial overgrowth (SIBO) may be the unifying patho...
null
Chronic Abdominal Pain Small Intestinal Bacterial Overgrowth
null
3
arm 1: Healthy controls arm 2: 2/3 Patients with CAP arm 3: 1/3 patients with CAP
[ 1, 1, 2 ]
4
[ 3, 0, 0, 3 ]
intervention 1: Healthy controls will receive one lactulose breath test to assess for SIBO intervention 2: xifaxan 550mg TID x10days intervention 3: placebo TID x 10days intervention 4: Children with CAP will receive one lactulose breath test to assess for SIBO and one after receiving either Rifaximin or Placebo
intervention 1: Lactulose Breath Test intervention 2: xifaxan intervention 3: placebo intervention 4: Lactulose Breath Test
1
Los Angeles | California | United States | -118.24368 | 34.05223
0
NCT00619970
[ 3 ]
17
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Patients with chronic kidney disease (CKD) and albuminuria are at increased risk of developing cardiovascular disease (CVD) which is often associated with hypertension, left ventricular hypertrophy, endothelial dysfunction and increased generation of reactive oxygen species (ROS). These patients also manifest a decreas...
ABSTRACT Background: Chronic kidney disease (CKD) is characterized by a high propensity to cardiovascular disease (CVD); therefore treatments that impact both CKD and CVD are needed. CKD is accompanied by endothelial dysfunction and nitric oxide (NO) deficiency. Tetrahydrobiopterin (BH4), an important co-factor for end...
Kidney Disease Albuminuria
Kidney Disease Albuminuria Glomerular filtration rate
null
1
arm 1: Subjects will receive 6R-BH4 400mg bid for 6 weeks, sequentially followed by 6R-BH4 plus Vitamin C 500mg bid for another 6 weeks. Patients will have scheduled visits at Weeks 0,3,6,9 and 12, with an exit-visit at week 16. Albuminuria will be assessed in 24-hour urine collections as well as early morning spot uri...
[ 0 ]
2
[ 0, 7 ]
intervention 1: 400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks in all arms intervention 2: 500 mg Vitamin C oral BID for another 6 weeks
intervention 1: 6R BH4 intervention 2: Vitamin C
1
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
0
NCT00625820
[ 3 ]
46
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to evaluate the effectiveness of ADL5859 in relieving pain associated with rheumatoid arthritis (RA) compared with placebo and naproxen (similar to Aleve®). A second objective is to see whether the effect of ADL5859 differs after a single dose compared with multiple doses.
This Phase 2a study was conducted in 2 parts. Part A was a randomized, single-dose, double-blind, placebo- and active-controlled, 3-way crossover phase during which participants were administered study medication in the clinical facility. Part B was a 14-day, randomized, double-blind, placebo-controlled, parallel-group...
Rheumatoid Arthritis
Rheumatoid arthritis arthritis
null
5
arm 1: ADL5859: 200 milligrams (mg), capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study arm 2: Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study arm 3: Matching placebo, capsules, administered orally...
[ 0, 1, 2, 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: ADL5859 intervention 2: Naproxen intervention 3: Placebo intervention 4: ADL5859 intervention 5: Placebo
8
Trumbull | Connecticut | United States | -73.20067 | 41.24287 Daytona Beach | Florida | United States | -81.02283 | 29.21081 Wheaton | Maryland | United States | -77.05526 | 39.03983 Omaha | Nebraska | United States | -95.94043 | 41.25626 Las Vegas | Nevada | United States | -115.13722 | 36.17497 Mineola | New York | U...
0
NCT00626275
[ 4 ]
69
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
To determine the safety of levocetirizine in children ages 6-11 months with symptoms of allergic rhinitis or chronic idiopathic urticaria.
null
Allergic Rhinitis Chronic Urticaria
Xyzal Levocetirizine Allergy Children Seasonal Allergies
null
2
arm 1: None arm 2: None
[ 2, 0 ]
2
[ 0, 10 ]
intervention 1: Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed once a day for 2 weeks intervention 2: Placebo oral liquid once a day for two weeks
intervention 1: Levocetirizine 1.25 mg intervention 2: Placebo
26
Birmingham | Alabama | United States | -86.80249 | 33.52066 Hot Springs | Arkansas | United States | -93.05518 | 34.5037 Jonesboro | Arkansas | United States | -90.70428 | 35.8423 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Bakersfield | California | United States | -119.01871 | 35.37329 Crescent City...
0
NCT00628108
[ 4 ]
430
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adult patients with persistent asthma.
A secondary objective is to collect safety data for treatment wtih Symbicort Single inhaler Therapy in adult patients with persistent asthma.
Asthma
Symbicort Turbuhaler Persistent Asthma
null
2
arm 1: Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed) arm 2: Conventional Best Practice for Treatment of Asthma
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed) intervention 2: Salbulin inh. 200-400 dosage 100 microgram (mcg)/dosage Salbutamol Sustained Release(SR)capsule 4 mg/8 mg Salbutol tablet (tb) 2 mg Salbutol forte syrup 2 mg/5 ml Ventolin tb, syrup, intravenou...
intervention 1: Symbicort TBH - Turbuhaler intervention 2: beta-II-agonist, inhale steroid
15
Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987 Antalya | N/A | Turkey (Türkiye) | 30.69556 | 36.90812 Bursa | N/A | Turkey (Türkiye) | 29.06013 | 40.19559 Denizli | N/A | Turkey (Türkiye) | 29.0875 | 37.77417 Diyarbakır | N/A | Turkey (Türkiye) | 40.21721 | 37.91363 Edirne | N/A | Turkey (Türkiye) | 26.55597 | 4...
0
NCT00628758
[ 0 ]
1
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
3TRIPLE
false
2MALE
null
RATIONALE: Testosterone gel may be effective in preventing or lessening muscle weakness caused by steroid therapy in men receiving glucocorticoids for newly diagnosed high-grade glioma. PURPOSE: This randomized clinical trial is studying how well testosterone gel works in preventing weakness caused by steroid therapy ...
OBJECTIVES: Primary * To determine if daily administration of testosterone gel can prevent the development or reduce the severity of muscle weakness in men receiving glucocorticoids for newly diagnosed high-grade glioma. Secondary * To compare the difference in percent change from baseline timed functional tests (T...
Brain and Central Nervous System Tumors Musculoskeletal Complications
musculoskeletal complications adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult giant cell glioblastoma adult glioblastoma adult gliosarcoma
null
2
arm 1: whey protein powder arm 2: Testosterone Gel (10g pouch/day) applied to skin
[ 2, 1 ]
2
[ 0, 7 ]
intervention 1: Application of testosterone gel intervention 2: None
intervention 1: testosterone gel applied to skin intervention 2: whey powder protein
1
Baltimore | Maryland | United States | -76.61219 | 39.29038
0
NCT00631137
[ 5 ]
93
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Randomized, multi-center, open label, active-comparator study to compare the efficacy and tolerability of Doryx Delayed Release Tablets to doxycycline hyclate in patients with moderate to severe acne vulgaris.
Efficacy of Doryx Delayed Release Tablets to doxycycline hyclate will be assessed using an Investigator's Global Assessment (IGA) score and the absolute change from baseline to 12 weeks in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline...
Acne Vulgaris
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 150mg/day, oral, delayed release tablets intervention 2: 100 mg/day, oral, tablets, immediate release
intervention 1: Doxycycline hyclate (Doryx) intervention 2: Doxycycline hyclate
4
Vista | California | United States | -117.24254 | 33.20004 Miami | Florida | United States | -80.19366 | 25.77427 Louisville | Kentucky | United States | -85.75941 | 38.25424 Rochester | New York | United States | -77.61556 | 43.15478
0
NCT00635609
[ 3 ]
38
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active opioid dependence. The primary outcome measure is the severity of withdrawal symptoms meas...
Buprenorphine sublingual and buccal soluble films are being developed to be used for the same indication and over the same buprenorphine dose range as Subutex and Suboxone sublingual tablets in the treatment of opioid dependence. However, only films administered by the sublingual route were evaluated in this study. Th...
Opioid-related Disorders
Opioid dependence Opioid withdrawal symptoms
null
2
arm 1: Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours. Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours. arm 2: Day 1: Buprenorphine/nalo...
[ 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Buprenorphine soluble film strips administered sublingually with doses escalated from 12 mg per day up to 24 mg daily for 5 days of total treatment. intervention 2: Buprenorphine/naloxone soluble film strips administered sublingually with doses escalated from 12 mg buprenorphine/3 mg naloxone to 24 mg b...
intervention 1: Buprenorphine soluble film intervention 2: Buprenorphine/naloxone film strip intervention 3: Placebo
1
Baltimore | Maryland | United States | -76.61219 | 39.29038
0
NCT00637000
[ 4 ]
322
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
true
0ALL
true
To evaluate the safety and tolerability of raxibacumab in healthy subjects.
null
Healthy
healthy volunteers
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 0, 2, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 40 mg/kg intravenously, double dose (day 0 and 14), Group 3 intervention 2: 40 mg/kg intravenously, double dose (day 0 and 14), Group 1 intervention 3: 40 mg/kg placebo, single dose (day 0), Group 4 intervention 4: 40 mg/kg intravenously, single dose, day 0, Group 2
intervention 1: placebo intervention 2: raxibacumab intervention 3: placebo intervention 4: raxibacumab
0
null
0
NCT00639678
[ 0 ]
27
NA
SINGLE_GROUP
7BASIC_SCIENCE
0NONE
false
0ALL
false
This study will explore the effect of clopidogrel on coated-platelets in patients who are given a loading dose before diagnostic catheterization or percutaneous coronary intervention. We hypothesis that clopidogrel will reduce the percentage of platelets that are coated and therefore more hypercoagulable.
Platelet activity will be determined by light transmission aggregometry at baseline, after a 300 mg dose of clopidogrel and after the catheterization and/or angioplasty procedure. The change in the percentage of platelets that are coated platelets will be determined.
Coronary Artery Disease Chest Pain
Platelets, platelet aggregation inhibitors
null
0
null
null
1
[ 0 ]
intervention 1: All subjects will receive a 300 mg loading dose
intervention 1: Clopidogrel
1
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
0
NCT00644657
[ 3 ]
376
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to test the safety and effectiveness of JNJ-28431754 in promoting weight loss in patients who are overweight or obese and who do not have diabetes.
The prevalence of obesity is increasing worldwide. Obesity and being overweight are major risk factors for chronic cardiovascular disease, type 2 diabetes mellitus, hypertension and stroke, and certain types of cancers. JNJ-28431754 is being investigated in this study for its possible effectiveness in promoting weight ...
Obesity
Obesity Overweight Weight loss Anti-Obesity Agents Human
null
4
arm 1: Each patient will receive 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. arm 2: Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. arm 3: Each patient will receive 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. arm 4: Each patient will recei...
[ 0, 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: One 50 mg, 100 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks. intervention 2: One matching placebo capsule orally once daily for 12 weeks.
intervention 1: Canagliflozin (JNJ-28431754) intervention 2: Placebo
36
Hot Springs | Arkansas | United States | -93.05518 | 34.5037 Walnut Creek | California | United States | -122.06496 | 37.90631 Westlake Village | California | United States | -118.80565 | 34.14584 Destin | Florida | United States | -86.49578 | 30.39353 Jacksonville | Florida | United States | -81.65565 | 30.33218 Augus...
0
NCT00650806
[ 4 ]
100
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
The primary purpose of this study is to compare the incidence of residual neuromuscular blockade at the time of tracheal extubation after reversal of rocuronium bromide-induced neuromuscular blockade by 4 mg/kg sugammadex with that of 50 µg/kg neostigmine. Residual neuromuscular blockade is defined as the fourth twitc...
Undetected residual neuromuscular blockade is common in the post-anesthesia care unit (PACU). In fact, 16%-42% of patients receiving intermediate-acting muscle relaxants in the operating room have T4/T1 ratios \<0.7-0.8 in the PACU. Respiratory and pharyngeal muscle function can be adversely affected during minimal n...
Anesthesia
null
2
arm 1: 4 mg/kg sugammadex arm 2: 50 µg/kg neostigmine
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Participants received 4 mg/kg sugammadex at 1-2 Post Tetanic Counts (PTCs) or better after the last dose of rocuronium bromide. intervention 2: Participants received 50 µg/kg neostigmine combined with 10 µg/kg glycopyrrolate after the last dose of rocuronium bromide as per standard of care. intervention...
intervention 1: Sugammadex intervention 2: Neostigmine intervention 3: Rocuronium
0
null
0
NCT00675792
[ 2 ]
42
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
true
The primary objective of this study is to determine the bioequivalence of the combination of pyronaridine and artesunate (180:60mg) to-be-marketed tablet to the clinical trial reference tablet administered as a single total dose of 720:240 mg in healthy adults. The secondary objective is to assess the safety of the two...
This is a phase I, randomized, single dose, two-way cross-over study of two tablet formulations of the combination of pyronaridine and artesunate (180:60 mg). The study will include 42 healthy participants, comprising male and female adults. Participants will be randomized to receive either reference tablet formulatio...
Malaria
Malaria anti-malarial pyronaridine pyronaridine artesunate (Pyramax) artemisinin based combination therapy (ACT)
null
2
arm 1: Participants first received clinical trial reference 720:240 mg tablets on Day 0. After a washout period of 43 days, they then received to-be-marketed 720:240 mg tablets on Day 43, with a follow-up period of 42 days. arm 2: Participants first received to-be-marketed 720:240 mg tablets on Day 0. After a washout p...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Single total oral dose of 720:240 mg (4 tablets of 180:60 mg) intervention 2: Single total oral dose of 720:240 mg (4 tablets of 180:60 mg)
intervention 1: pyronaridine artesunate clinical trial reference tablets intervention 2: pyronaridine artesunate to-be-marketed tablets
1
Arzo | N/A | Switzerland | 8.94103 | 45.87606
0
NCT00682630
[ 5 ]
11
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
In this study, adult Indonesian subjects with human immunodeficiency virus (HIV) coinfected with chronic hepatitis C (CHC) will be given peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) combination therapy. The efficacy rate (sustained virologic response, end of treatment virologic response, and sustained biochemic...
null
Hepatitis C, Chronic Hepacivirus HIV Infections
HIV
null
1
arm 1: PEG-IFN + RBV therapy in previously untreated chronic HCV subjects coinfected with HIV
[ 0 ]
2
[ 2, 0 ]
intervention 1: Subjects will be given peginterferon alfa-2b (PEG-IFN) subcutaneously, at a dose of 1.5 ug/kg weekly. Treatment duration will be 48 weeks for subjects with Hepatitis C Virus (HCV) genotype 1 and 24 weeks for subjects with HCV genotype 2 or 3 and baseline Hepatitis C Virus-ribonucleic acid (HCV-RNA) belo...
intervention 1: Peginterferon alfa-2b (SCH 054031) intervention 2: Ribavirin (SCH 018908)
0
null
0
NCT00687544
[ 3 ]
44
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
true
0ALL
false
Evaluate the efficacy of combination therapy AEGR-733 plus atorvastatin 20 mg versus monotherapy on serum lipoproteins over 4 and 8 weeks of therapy. The primary efficacy parameter is percent change in LDL-C after 8 weeks of therapy.
Following a 35-day washout of current lipid-lowering medication (if any) and adherence to a low-fat diet, subjects will receive either atorvastatin 20 mg for 8 weeks, OR AEGR-733 2.5 mg + atorvastatin 20 mg for 4 weeks followed by AEGR-733 5 mg + atorvastatin 20 mg for 4 additional weeks. During the entire study, subje...
Hypercholesterolemia
Hyperlipidemia
null
2
arm 1: 2.5 mg AEGR 733 plus atorvastatin 20 mg weeks 1-4 followed by 5 mg AEGR 733 plus atorvastatin 20 mg weeks 5-8 arm 2: Following 35-day washout + diet run-in, subjects receive atorvastatin 20 mg for 8 wks.
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: atorvastatin 20 mg tablets, daily dosing, for 8 weeks. intervention 2: 2.5 mg AEGR-733 capsules, daily dosing, 4 weeks followed by 5 mg AEGR-733 capsules, daily dosing, 4 weeks
intervention 1: Atorvastatin intervention 2: AEGR-733
5
Pinellas Park | Florida | United States | -82.69954 | 27.8428 Edina | Minnesota | United States | -93.34995 | 44.88969 Mogadore | Ohio | United States | -81.39789 | 41.04645 Dallas | Texas | United States | -96.80667 | 32.78306 San Antonio | Texas | United States | -98.49363 | 29.42412
0
NCT00690443
[ 4 ]
100
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
false
0ALL
false
The purpose of the study is to determine whether a modified propofol preparation shows any effect on the incidence of injection pain in adults undergoing elective surgery under general anesthesia. Study hypothesis: The use of a modified propofol preparation will reduce the incidence of injection pain in the study grou...
Pain on injection is a most frequently reported side effect associated with the use of propofol for induction of anesthesia. Various measures have been taken to reduce the pain on injection, e.g. administration of lidocaine or fentanyl prior to propofol administration, mixture of lidocaine and propofol as well as cooli...
Anesthesia
Anesthesia Induction Pain
null
2
arm 1: Modified propofol (Propofol 0.5%) arm 2: Propofol 1%
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Propofol (drug), intravenous, induction of anesthesia intervention 2: Propofol (drug), intravenous, induction of anesthesia
intervention 1: Propofol intervention 2: Propofol 1%
1
Leverkusen | North Rhine-Westphalia | Germany | 6.98432 | 51.0303
0
NCT00690495
[ 5 ]
26
RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this research study is to better understand adherence to Locoid when people use it to treat atopic dermatitis.
An investigator-blinded prospective study of subjects with mild to moderate atopic dermatitis (\>5% Body Surface area and 2 or 3 on the Investigator Global Assessment (IGA) scale). The drug will be used within FDA-approved labeling. Subjects will be randomized to each of the following topical hydrocortisone 17-butyrate...
Atopic Dermatitis
null
3
arm 1: topical hydrocortisone 17-butyrate 0.1% Cream preparation applied twice daily to all lesions of atopic dermatitis arm 2: topical hydrocortisone 17-butyrate 0.1% Ointment preparation applied twice daily to all lesions of atopic dermatitis arm 3: topical hydrocortisone 17-butyrate 0.1% Lipocream preparation applie...
[ 1, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Apply medication twice a day to affected areas of atopic dermatitis intervention 2: Apply medication twice a day to affected areas of atopic dermatitis intervention 3: Apply medication twice a day to affected areas of atopic dermatitis
intervention 1: hydrocortisone 17-butyrate 0.1% Cream preparation intervention 2: hydrocortisone 17-butyrate 0.1% Ointment preparation intervention 3: hydrocortisone 17-butyrate 0.1% Lipocream preparation
1
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
0
NCT00693693
[ 3 ]
25
RANDOMIZED
SINGLE_GROUP
0TREATMENT
1SINGLE
true
0ALL
false
The objective of the study is to compare the healing of wounds induced by cryo-injury when treated with white petrolatum versus an ointment vehicle.
null
Wounds
White Petrolatum Xenaderm Vehicle Partial thickness wounds Healing Cryo-surgery
null
2
arm 1: Xenaderm Vehicle arm 2: Placebo Comparator
[ 5, 2 ]
2
[ 0, 10 ]
intervention 1: Ointment to be applied three times a day on cryo-surgery wound for 21 days. intervention 2: Ointment to be applied three times a day on cryo-surgery wound for 21 days.
intervention 1: Xenaderm Vehicle intervention 2: Placebo comparator
1
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
0
NCT00713349
[ 5 ]
51
RANDOMIZED
SINGLE_GROUP
0TREATMENT
1SINGLE
false
0ALL
false
Pliaglis® Cream versus compounded topical anesthetic for pain management during Restylane® injections for the correction of nasolabial folds.
Open-label, randomized study designed to assess the effectiveness of a topical anesthetic (Pliaglis® Cream) versus a compounded topical anesthetic at needle stick, immediately after, one and three hours after Restylane® injections in the nasolabial folds.
Nasolabial Folds
Nasolabial folds wrinkles topical anesthetic
null
2
arm 1: tetracaine 4% / lidocaine 7% cream; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and a compounded topical anesthetic ointment was used on the other side of the face. Restylane® was injected into both sides of the face. arm 2: apply benzocaine / lidocaine / tetrac...
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Apply tetracaine/lidocaine cream once on one side of the face prior to Restylane® injections intervention 2: apply benzocaine / lidocaine / tetracaine ointment once on the other side of the face prior to Restylane® injections
intervention 1: tetracaine 7% / lidocaine 7% cream (Pliaglis® Cream) intervention 2: benzocaine 20% / lidocaine 6% / tetracaine 4% ointment
4
Aventura | Florida | United States | -80.13921 | 25.95648 West Palm Beach | Florida | United States | -80.05337 | 26.71534 New York | New York | United States | -74.00597 | 40.71427 Spokane | Washington | United States | -117.42908 | 47.65966
0
NCT00716443
[ 4 ]
328
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to evaluate the efficacy and safety of JNS013 with single oral dose administration in participants with pain after tooth-extraction of mandibular impacted wisdom tooth.
This is a multi-center (conducted in more than one center), double-blind (neither Physician nor participant knows the name of the assigned drug), randomized (study drug assigned by chance), parallel-group (each group of participant will be treated at the same time) and comparative study in participants having pain inte...
Pain Postoperative Pain
Pain Tooth extraction Oral surgery Postoperative pain JNS013 Tramadol hydrochloride Acetaminophen
null
3
arm 1: Tramadol hydrochloride and acetaminophen combination tablet will be administered as single oral dosing of two tablets at a dose of 75 and 650 milligram respectively, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater tha...
[ 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Tramadol hydrochloride two oral capsules will be administered once as 75 milligram (mg). intervention 2: Acetaminophen two oral capsules will be administered once as 650 mg. intervention 3: Two oral tablets or capsules of matching Placebo will be administered once along with Tramadol Hydrochloride and/o...
intervention 1: Tramadol Hydrochloride intervention 2: Acetaminophen intervention 3: Placebo intervention 4: Tramadol plus Acetaminophen
11
Isehara | N/A | Japan | 139.31019 | 35.39932 Kitakyushu | N/A | Japan | 130.85034 | 33.85181 Kumamoto | N/A | Japan | 130.69181 | 32.80589 Ohta-Ku | N/A | Japan | N/A | N/A Osaka | N/A | Japan | 135.50107 | 34.69379 Sapporo | N/A | Japan | 141.35 | 43.06667 Shimotsuga | N/A | Japan | N/A | N/A Shimotsuke | N/A | Japan ...
0
NCT00737048
[ 5 ]
45
RANDOMIZED
PARALLEL
2DIAGNOSTIC
2DOUBLE
true
0ALL
false
This investigation is designed to compare lubiprostone and placebo for cleansing and propulsion in preparation for capsule endoscopy.
Introduction of small bowel capsule endoscopy made available an unique technique for diagnostic evaluation of the gastrointestinal tract. After esophagogastroduodenoscopy and colonoscopy about 5% of bleeding cases remain unexplained and capsule endoscopy provides small bowel yield. Capsule endoscopy has special applica...
Inflammatory Bowel Disease
capsule endoscopy prokinetic lubiprostone Normal volunteers
null
2
arm 1: lubiprostone 24mcg single dose po prior to capsule endoscopy arm 2: Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 24 mcg oral administration intervention 2: Oral administration
intervention 1: Lubiprostone intervention 2: Placebo
1
Mobile | Alabama | United States | -88.04305 | 30.69436
0
NCT00746395
[ 0 ]
79
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
A study using characteristics on ultrasound to predict response to intraarticular steroid injections in patients with knee osteoarthritis. The hypothesis is that patients with inflammation on ultrasound will have a better response to corticosteroid injections compared to patients without inflammation.
null
Osteoarthritis
osteoarthritis knee corticosteroids ultrasound
null
2
arm 1: 40 mg of intraarticular triamcinolone acetonide arm 2: Intraarticular injection of 0.9% saline
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: single intraarticular injection of 40 mg of triamcinolone acetonide intervention 2: Single intraarticular injection of 1 ml of 0.9% saline
intervention 1: triamcinolone acetonide intervention 2: saline
2
La Jolla | California | United States | -117.2742 | 32.84727 La Jolla | California | United States | -117.2742 | 32.84727
0
NCT00746889
[ 0 ]
76
RANDOMIZED
CROSSOVER
4SUPPORTIVE_CARE
2DOUBLE
true
0ALL
false
The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format.
The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format by observing changes within the cornea and collecting subje...
Ametropia
comfort wetability protein deposit lipid deposit
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 1, 1, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover intervention 2: Marketed Multipurpose Disinfecting Care System intervention 3: Marketed Multipurpose Disinfecting Care Systems
intervention 1: Alcon Opti-Free® RepleniSH® with Supraclens® intervention 2: Alcon Opti-Free® RepleniSH® intervention 3: B&L ReNu MultiPlus™
1
Waterloo | Ontario | Canada | -80.51639 | 43.4668
0
NCT00754338
[ 4 ]
24
RANDOMIZED
CROSSOVER
0TREATMENT
1SINGLE
true
0ALL
false
To compare the antimicrobial efficacy of three dentifrices on oral bacteria
null
Oral Bacteria
null
3
arm 1: fluoride toothpaste arm 2: Stannous fluoride toothpaste arm 3: fluoride/triclosan/copolymer toothpaste
[ 2, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Brush twice a day for 14 days intervention 2: Brush twice daily for 14 days intervention 3: Brush twice daily for 14 days
intervention 1: Fluoride intervention 2: Fluoride, Triclosan intervention 3: Stannous Fluoride
1
Newark | New York | United States | -77.09525 | 43.04673
0
NCT00762177
[ 0 ]
39
RANDOMIZED
PARALLEL
6HEALTH_SERVICES_RESEARCH
0NONE
false
0ALL
true
The purpose of this study is to compare the effect on LDL cholesterol levels of converting patients who are receiving the cholesterol absorption inhibitor Zetia at a dose of 10 milligrams to 5 milligrams, when prescribed as a split 10 milligram tablet.
null
Hypercholesterolemia
Cholesterol Ezetimibe
null
2
arm 1: A whole ezetimibe 10 mg tablet arm 2: Ezetimibe 5 mg, "formulated" by splitting a 10 mg ezetimibe tablet in half
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: Ezetimibe 10 mg daily for 4 weeks intervention 2: Ezetimibe 5 mg daily for 4 weeks, "formulated" as a 10 mg tablet split in half
intervention 1: Ezetimibe 10 mg intervention 2: Ezetimibe 5 mg
1
The Bronx | New York | United States | -73.86641 | 40.84985
0
NCT00762229
[ 5 ]
13
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate in daily clinical practice the safety and efficacy of fentanyl Iontophoretic Transdermal (through the skin) System (ITS) for management of moderate (medium level of seriousness) to severe (very serious) acute (a quick and severe) pain in participants who have undergone elective ...
This is an open-label (participants and physicians are told which treatment the participants are receiving), multi-center (when more than one hospital or medical school team work on a medical research study), single-arm study of fentanyl ITS. The study will consist of 2 phases: screening phase and an open-label treatme...
Pain, Postoperative
IONSYS Fentanyl Iontophoretic Transdermal System Postoperative pain
null
1
arm 1: 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS). Total duration of treatment will be 72 hours.
[ 0 ]
1
[ 0 ]
intervention 1: 40 mcg per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an ITS. Total duration of treatment will be 72 hours.
intervention 1: Fentanyl ITS
3
Aalst | N/A | Belgium | 4.0355 | 50.93604 Brussels | N/A | Belgium | 4.34878 | 50.85045 Edegem | N/A | Belgium | 4.44504 | 51.15662
0
NCT00779038
[ 3 ]
80
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
true
1FEMALE
false
The purpose of this study is to determine the effectiveness of paracervical block for pain relief in office hysteroscopy - particularly with the placement of the Essure device. Subjects will be randomized to receive either paracervical block or saline, and will have pain assessments performed throughout the procedure. ...
null
Paracervical Block
Hysteroscopy Pain medication Lidocaine Office Procedures
null
2
arm 1: 5cc 1% lidocaine injection in each paracervical region arm 2: 5cc Normal Saline injection in each paracervical region
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 5cc 1% lidocaine injection in each paracervical region intervention 2: 5cc Normal Saline injection in each paracervical region
intervention 1: Lidocaine paracervical block intervention 2: Normal Saline
1
The Bronx | New York | United States | -73.86641 | 40.84985
0
NCT00811187
[ 5 ]
113
RANDOMIZED
PARALLEL
9OTHER
2DOUBLE
false
0ALL
false
It is hypothesized that treating insomnia in migraineurs, many of whom also have tension headaches, prolongs total sleep time to the extent that it decreases overall headache frequency. Chronic headache sufferers also feel more tired during the day, undoubtedly affecting daytime functioning, which is hypothesized to im...
The objective of the study is to determine the effect of prolonging total sleep time in migraineurs with insomnia on overall headache frequency, daytime alertness, fatigue, and functioning. The prolongation of total sleep time is accomplished by bedtime administration of 3 mg eszopiclone (Lunesta™), compared with place...
Insomnia Migraine
insomnia migraine eszopiclone insomnia in migraineurs
null
2
arm 1: Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with 3mg eszopiclone, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an e...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 3 mg tablet every night at bedtime intervention 2: 1 tablet every night at bedtime
intervention 1: eszopiclone intervention 2: placebo
0
null
0
NCT00812214
[ 0 ]
55
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study is to compare the effectiveness of using topical cream of Ping On Ointment and using Vaseline cream in the treatment of temporomandibular joint (TMJ) and masticatory muscle pain, in order to establish the true efficacy of Ping On Ointment. Both Ping On Ointment and Vaseline are considered inte...
Aims: To compare the effectiveness of using topical cream of Ping On Ointment and using Vaseline cream in the treatment of temporomandibular joint (TMJ) and masticatory muscle pain, in order to establish the true efficacy of Ping On Ointment. Methods: In this randomized, double-blinded, placebo-controlled trial, 55 sub...
Temporomandibular Disorders
null
2
arm 1: Ping On Ointment arm 2: Vaseline with minor trace of Ping On ointment to give medicinal smell
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Ping On Ointment intervention 2: Placebo
intervention 1: Ping On Ointment intervention 2: Vaseline
1
Hong Kong | Hong Kong | China | 114.17469 | 22.27832
0
NCT00812604
[ 4 ]
580
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to evaluate the efficacy and safety of two fixed doses (16mg/day and 24mg/day) of galantamine (a drug for treating dementia) versus placebo for the treatment of patients with Alzheimer's disease.
This is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient know the name of the study medication), placebo-controlled, parallel-group study to evaluate the efficacy and safety of two fixed doses of galantamine (16 and 24 milligrams per day \[mg/day\]) in patients with Alzh...
Alzheimer's Disease
Alzheimer's Disease Cognitive dysfunction Dementia Galantamine R113675
null
3
arm 1: None arm 2: None arm 3: None
[ 2, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Form= tablet, route= oral use. Corresponding placebo tablets confirmed to be indistinguishable from the galantamine tablets will be administered for 24 weeks. intervention 2: Type= exact number, number= 8, 16, unit= mg/day, form= tablet, route= oral use. Patients will receive 8 mg galantamine daily for ...
intervention 1: Placebo intervention 2: Galantamine 16 mg/day intervention 3: Galantamine 24 mg/day
1
Fukuoka | N/A | Japan | 130.41667 | 33.6
0
NCT00814801
[ 4 ]
12
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
false
This study will help determine if behavior modification performed in conjunction with oral Vesicare anticholinergic therapy is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.
Overactive bladder symptoms are commonly treated with oral anticholinergic medications that work by stopping muscles from tightening or behavioral modification. This study will help determine if behavior modification (fluid regulation, pelvic exercises, timed voiding) performed in conjunction wth oral Vesicare antichol...
Overactive Bladder
urinary incontinence overactive bladder urinary frequency
null
2
arm 1: Vesicare alone arm 2: Vesicare plus behavioral modification
[ 1, 1 ]
2
[ 0, 5 ]
intervention 1: 5mg po qd intervention 2: 5 mg dose po once daily plus behavioral modification
intervention 1: Vesicare (solifenacin) intervention 2: Vesicare (solifenacin) plus behavioral modification
1
Burlington | Massachusetts | United States | -71.19561 | 42.50482
0
NCT00821184
[ 3 ]
536
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
true
The primary objective of this study is to compare the incidence of hemorrhagic events in patients treated for non-valvular atrial fibrillation with DU-176b at each dose level versus warfarin potassium (warfarin). The secondary objective includes between-group comparisons with regard to incidence of thromboembolic event...
null
Atrial Fibrillation
Atrial fibrillation Factor Xa inhibition
null
4
arm 1: DU-176b low dose arm 2: DU-176b intermediate dose arm 3: DU-176b high dose arm 4: Warfarin
[ 0, 0, 0, 1 ]
2
[ 0, 0 ]
intervention 1: DU-176b tablets taken once daily for up to 12 weeks intervention 2: Warfarin potassium tablets taken once daily for up to 12 weeks
intervention 1: DU-176b tablets intervention 2: Warfarin potassium tablets
1
Tokyo | N/A | Japan | 139.69171 | 35.6895
0
NCT00829933
[ 5 ]
23
NA
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
false
The main purpose of this study is to determine whether treatment with acarbose attenuates post-prandial glycemic excursions in non-diabetic/pre-diabetic obese children as determined by continuous glucose monitoring systems (CGMS). To this effect the current pilot study involves a 6 week intervention with acarbose given...
We are particularly interested in examining whether acarbose lowered the percentage of glucose excursions ≥ 140 mg/dl in a real-life, home environment. At baseline, subjects underwent an oral glucose tolerance test (OGTT) and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg wit...
Pediatric Obesity Insulin Resistance Impaired Glucose Tolerance Cardiovascular Disease
Pediatric Obesity Insulin Resistance Glucose Tolerance Adolescents Acarbose Continuous Glucose Monitoring (CGMS) Endothelial Dysfunction
null
1
arm 1: At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study.
[ 0 ]
1
[ 0 ]
intervention 1: At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study.
intervention 1: Acarbose
1
New Haven | Connecticut | United States | -72.92816 | 41.30815
0
NCT00846521
[ 5 ]
137
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
true
1FEMALE
true
The purpose of this study is to compare the pain perception between lidocaine and plain aqueous gel during assessment of postvoid residual volume and the Q-tip test.
This study was approved by the institutional review board at Baystate Medical Center. The study pool consists of all women who present to a single urogynecologist's office for an initial consultation with a complaint of urinary incontinence and/or pelvic organ prolapse. Those patients who consent for the research will ...
Pain
female urethral catheterization Lidocaine lubricant Q-tip test Q tip test K-Y jelly pain perception straight catheterization
null
2
arm 1: 2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test. arm 2: Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test. intervention 2: Plain aqueous gel will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
intervention 1: 2% Lidocaine jelly intervention 2: Plain aqueous gel
1
Springfield | Massachusetts | United States | -72.58981 | 42.10148
0
NCT00883103
[ 5 ]
76
RANDOMIZED
CROSSOVER
9OTHER
0NONE
true
0ALL
false
To determine whether new 80 mg atorvastatin tablets are bioequivalent to 80 mg commercial atorvastatin tablets (Lipitor®).
null
Hypercholesterolemia
Bioqeuivalence, Pharmacokinetics, Atorvastatin
null
2
arm 1: 80 mg atorvastatin tablets arm 2: New 80 mg atorvastatin tablets
[ 5, 0 ]
2
[ 0, 6 ]
intervention 1: A single 80 mg dose of marketed 80 mg atorvastatin tablets intervention 2: A single dose of new formulation of 80 mg atorvastatin tablets
intervention 1: Atorvastatin intervention 2: Atorvastatin
1
Miami | Florida | United States | -80.19366 | 25.77427
0
NCT00917644
[ 2 ]
20
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
false
The primary objective was to investigate whether multiple-dose administration of eslicarbazepine acetate affects the pharmacokinetics of metformin.
null
Neuropathic Pain
eslicarbazepine acetate zebinix metformin
null
2
arm 1: Eslicarbazepine acetate + Metformin period followed by washout period followed by Metformin period arm 2: Metformin period followed by washout period followed by Eslicarbazepine acetate + Metformin period
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days intervention 2: None
intervention 1: Metformin intervention 2: Eslicarbazepine acetate
1
Mamede Do Coronado | N/A | Portugal | N/A | N/A
0
NCT00971295
[ 2 ]
46
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
To determine the long term safety and tolerability of dasatinib exposure in subjects previously treated in CA180-002.
null
Leukemia
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Tablets, Oral, The dosing ranges from 50mg to a total of 240mg daily with the following 3 schedules: * 5 days on, 2 days off * 6 days on, 1 day off * Continuous daily dosing Once Daily (QD) or Twice Daily (BID) dosing, Subjects will be treated until progression of disease despite escalation/reductions...
intervention 1: Dasatinib
0
null
0
NCT00978731
[ 0 ]
39
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
false
The objective of this study was to prove the bioequivalence of Imipramine Pamoate 75 mg Capsules under fasting conditions
null
Depression
null
2
arm 1: First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period) arm 2: First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)
[ 1, 1 ]
1
[ 0 ]
intervention 1: 75 mg capsule
intervention 1: Imipramine Pamoate
1
Houston | Texas | United States | -95.36327 | 29.76328
0
NCT01107353
[ 5 ]
506
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to measure the safety, efficacy and quality of life of lansoprazole in patients with reflux disease over a five year period.
Lansoprazole is currently approved in Germany for the treatment of erosive reflux esophagitis and active duodenal and gastric ulcer disease, and for long-term treatment including maintenance of healed reflux esophagitis and duodenal ulcer disease and treatment of pathological hypersecretory conditions such as Zollinger...
Gastroesophageal Reflux
GERD Gastroesophageal Reflux Disease Drug Therapy
null
1
arm 1: Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks. Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months.
[ 0 ]
1
[ 0 ]
intervention 1: Lansoprazole capsules
intervention 1: Lansoprazole
0
null
0
NCT01135368
[ 3 ]
47
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The main objectives of this study were to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of vedolizumab in patients with ulcerative colitis (UC).
At the end of the study, eligible participants could enroll and receive treatment and follow-up in Study C13004 (NCT00619489). Participants who did not proceed into Study C13004 were followed by telephone contact at 6-month intervals for 2 years after the last administration of study treatment to collect reports of adv...
Ulcerative Colitis
null
4
arm 1: Vedolizumab-matching placebo, intravenous (IV), infusion on Days 1, 15, 29 and 85. arm 2: Vedolizumab, 2 mg/kg, IV infusion on Days 1, 15, 29 and 85. arm 3: Vedolizumab 6 mg/kg, IV infusion on Days 1, 15, 29 and 85. arm 4: Vedolizumab 10 mg/kg, IV infusion on Days 1, 15, 29 and 85.
[ 2, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Vedolizumab for intravenous infusion intervention 2: Placebo intravenous infusion
intervention 1: Vedolizumab intervention 2: Placebo
0
null
0
NCT01177228
[ 3 ]
438
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study was to evaluate the long-term safety and efficacy of SYR-322, once daily (QD), to an α-glucosidase inhibitor, three times daily (TID), administered for 40 consecutive weeks in participants who completed a phase 2 dose-ranging study.
Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus. Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV)...
Type 2 Diabetes Mellitus
Diabetes Mellitus - Type 2 Diabetes Mellitus Drug Therapy
null
5
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
[ 0, 0, 0, 0, 1 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. intervention 2: Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. intervention 3: Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. intervention 4: Alogliptin 50 mg, tablets, orally, once daily for up t...
intervention 1: Alogliptin intervention 2: Alogliptin intervention 3: Alogliptin intervention 4: Alogliptin intervention 5: Voglibose
0
null
0
NCT01263496
[ 3 ]
45
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This study will evaluate the correlation between the pharmacokinetic and pharmacodynamic parameters of CellCept in patients undergoing primary kidney transplantation, in order to assess the impact on clinical outcome and the risks of acute rejection. All patients will receive oral CellCept, 1g twice daily, and pharmaco...
null
Kidney Transplantation
null
1
arm 1: Participants received an initial dose of mycophenolate mofetil (MMF), 1 gram (g), orally (PO), twice per day (BID), within 5 days of transplant for 24 weeks. Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
[ 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 1 g PO BID for 24 weeks intervention 2: According to manufacturer recommendation intervention 3: According to manufacturer recommendation intervention 4: According to manufacturer recommendation
intervention 1: mycophenolate mofetil intervention 2: antibody induction intervention 3: Cyclosporine intervention 4: corticosteroid
7
Bari | N/A | Italy | 16.86982 | 41.12066 Brescia | N/A | Italy | 10.21472 | 45.53558 Coppito | N/A | Italy | 13.34358 | 42.3673 Napoli | N/A | Italy | 14.5195 | 40.87618 Roma | N/A | Italy | 11.10642 | 44.99364 Torino | N/A | Italy | 11.99138 | 44.88856 Verona | N/A | Italy | 10.9938 | 45.43854
0
NCT01292226
[ 2 ]
36
RANDOMIZED
CROSSOVER
null
0NONE
true
1FEMALE
false
The purpose of this study was to evaluate the relative bioavailability of a test formulation of norethindrone/ethinyl estradiol 0.4 mg/0.035 mg chewable tablets (Teva Pharmaceuticals, USA) compared to the reference listed product, FEMCON® Fe (norethindrone/ethinyl estradiol and ferrous fumarate) 0.4 mg/0.035 mg Chewabl...
null
Healthy
Healthy Subjects Bioequivalence
null
2
arm 1: Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets (Teva) arm 2: FEMCON® Fe 0.4 mg/0.035 mg Chewable tablets (Warner Chilcott)
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 0.4 mg/0.035 mg Chewable Tablets intervention 2: 0.4 mg/0.035 mg Chewable Tablets
intervention 1: Norethindrone/Ethinyl Estradiol intervention 2: FEMCON® Fe
1
Houston | Texas | United States | -95.36327 | 29.76328
0
NCT01344369
[ 5 ]
174
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate the safety and tolerability of the fentanyl iontophoretic transdermal (through the skin) system (fentanyl-ITS) in daily clinical practice for management of acute (a quick and severe form of illness in its early stage) moderate to severe post-operative pain (pain after surgery) i...
This is an open label (all people know the identity of the intervention), single arm, and multi-center (when more than one hospital or medical school team work on a medical research study) study to evaluate safety and efficacy of the fentanyl-ITS for management of acute moderate to severe pain in post-operative partici...
Postoperative Pain
Postoperative Pain Fentanyl Hydrochloride IONSYS
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) will release fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment will be 72 hours.
intervention 1: Fentanyl-ITS
22
Augsburg | N/A | Germany | 10.89851 | 48.37154 Berlin | N/A | Germany | 13.41053 | 52.52437 Bremen | N/A | Germany | 8.80717 | 53.07582 Cologne | N/A | Germany | 6.95 | 50.93333 Detmold | N/A | Germany | 8.87318 | 51.93855 Dresden | N/A | Germany | 13.73832 | 51.05089 Erfurt | N/A | Germany | 11.03283 | 50.9787 Erlange...
0
NCT01804673
[ 3 ]
149
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
null
This study will evaluate the efficacy and safety of pertuzumab in combination with carboplatin-based standard chemotherapy in patients with platinum-sensitive recurrent ovarian cancer. The anticipated time on study treatment is 3-12 months.
null
Ovarian Cancer
null
2
arm 1: None arm 2: None
[ 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks intervention 2: 175 mg/m2 IV every 3 weeks for 6 cycles intervention 3: 1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles intervention 4: Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles
intervention 1: pertuzumab intervention 2: paclitaxel intervention 3: gemcitabine intervention 4: carboplatin
34
Brussels | N/A | Belgium | 4.34878 | 50.85045 Leuven | N/A | Belgium | 4.70093 | 50.87959 Wilrijk | N/A | Belgium | 4.39513 | 51.16734 Calgary | Alberta | Canada | -114.08529 | 51.05011 Kelowna | British Columbia | Canada | -119.48568 | 49.88307 Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Budapest | N...
0
NCT02004093
[ 2 ]
34
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
true
2MALE
false
The purpose of this study is to assess the tolerability of BIA 9-1067 after multiple rising dose regimens of BIA 9-1067.
Single centre, double-blind, randomised, placebo-controlled study of four dosage regimens of BIA 9-1067 in four groups of healthy male volunteers. In each group, the study will consist of an once-daily (o.d.) 8-day multiple-dose period. Progression to the next dose level will only occur if the previous dose level was c...
Parkinson's Disease (PD)
Parkinson's disease (PD) Opicapone Bial BIA 9-1067
null
5
arm 1: BIA 9-1067 (OPC, Opicapone) 5 mg arm 2: BIA 9-1067 (OPC, Opicapone) 10 mg arm 3: BIA 9-1067 (OPC, Opicapone) 20 mg arm 4: BIA 9-1067 (OPC, Opicapone) 30 mg arm 5: Placebo, PLC
[ 0, 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: BIA 9-1067 intervention 2: Placebo
1
Rueil | Malmaison | France | 1.87938 | 49.047
0
NCT02071810
[ 3 ]
220
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The primary objective of this study is to evaluate the analgesic efficacy of RN624 compared with placebo and compared with naproxen in the treatment of adult patients with chronic low back pain.
null
Low Back Pain
null
3
arm 1: None arm 2: None arm 3: None
[ 1, 2, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Oral naproxen 500 mg twice daily for Weeks 1-12. intervention 2: Single IV infusion of placebo on Day 1 and placebo for naproxen twice daily for Weeks 1-12. intervention 3: Single IV infusion of 200 micrograms/kg RN624 on Day 1
intervention 1: Naproxen intervention 2: Placebo intervention 3: PF-04383119 (RN624)
38
Anniston | Alabama | United States | -85.83163 | 33.65983 Birmingham | Alabama | United States | -86.80249 | 33.52066 Chandler | Arizona | United States | -111.84125 | 33.30616 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Anaheim | California | United States | -117.9145 | 33.83529 San Diego | California...
0
NCT00584870
[ 2, 3 ]
117
NON_RANDOMIZED
SEQUENTIAL
0TREATMENT
0NONE
false
0ALL
false
This trial was a Phase I/II, non-randomized, open label, multi-center study, following a sequential 2-part design.
The first part, Phase I, was designed to assess whether there is a pharmacokinetic interaction between Glivec/Gleevec (imatinib) and RAD001(everolimus) as well as to collect safety data when these two drugs are co-administered. The second part, (Phase II), was designed to assess the potential efficacy of the combinatio...
Gastrointestinal Stromal Tumors
RAD001 everolimusGIST everolimus mTOR Imatinib resistant Imatinib-refractory/resistant gastrointestinal stromal tumors Gastrointestinal Stromal Tumors(GIST) soft tissue sarcoma stomach tumor tumor of interstitial cells of Cajal (ICC) digestive system cancer
null
6
arm 1: RAD001 20 mg was given once a week. arm 2: RAD001 2.5 mg was given in combination with Glivec/Gleevec 600mg/day. arm 3: RAD001 5 mg was given in combination with Glivec/Gleevec 600mg/day. arm 4: RAD001 2.5 mg was given in combination with Glivec/Gleevec 800mg/day. arm 5: All first-line resistant/refractory patie...
[ 0, 0, 0, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: RAD001 was in tablets of 0.5 mg, 1.0 mg, 2.5 mg and 5.0 mg strength and was taken by mouth, once a week or once a day depending upon the treatment group the patient was enrolled into. intervention 2: Glivec/Gleevec was supplied as commercialized 100 mg and 400 mg tablets. Gleevec/Glivec was provided as ...
intervention 1: RAD001 intervention 2: Imatinib 600mg/day (Glevec is the brand name for imatinib) intervention 3: Imatinib 800mg/day (Glevec is the brand name for imatinib)
16
Boston | Massachusetts | United States | -71.05977 | 42.35843 New York | New York | United States | -74.00597 | 40.71427 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Edegem | Antwerpen | Belgium | 4.44504 | 51.15662 Leuven | N/A | Belgium | 4.70093 | 50.87959 Bordeaux | N/A | France | -0.5805 | 44...
0
NCT01275222
[ 4 ]
862
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
Rosiglitazone (RSG) has been tested and is approved as a treatment for type II diabetes mellitus, a disease that occurs when the body ineffectively uses glucose. RSG XR, the investigational drug, is an extended-release form of RSG. This study tests whether RSG XR safely provides benefit to people with mild to moderate ...
A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer's disease. (REFLECT-1)
Alzheimer's Disease
apolipoprotein E monotherapy cognition mild rosiglitazone Alzheimer's disease moderate
null
2
arm 1: XR (extended release) oral tablets arm 2: Placebo (Double-Dummy to Match)
[ 0, 5 ]
1
[ 0 ]
intervention 1: XR (extended release) oral tablets
intervention 1: Rosiglitazone
138
Phoenix | Arizona | United States | -112.07404 | 33.44838 Los Angeles | California | United States | -118.24368 | 34.05223 Newport Beach | California | United States | -117.92895 | 33.61891 Palo Alto | California | United States | -122.14302 | 37.44188 Reseda | California | United States | -118.53647 | 34.20112 San Die...
1
NCT00428090
[ 4 ]
668
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.
null
Macular Edema Retinal Vein Occlusion
null
3
arm 1: 700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180. arm 2: 350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. arm 3: Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
[ 0, 0, 3 ]
3
[ 0, 0, 10 ]
intervention 1: 700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180. intervention 2: 350 µg Dexamethasone intravitreal implant administered on Day 0. intervention 3: Sham injection on Day 0.
intervention 1: 700 µg Dexamethasone intervention 2: 350 µg Dexamethasone intervention 3: Sham Injection
13
Houston | Texas | United States | -95.36327 | 29.76328 São Paulo | N/A | Brazil | -46.63611 | -23.5475 Mississauga | Ontario | Canada | -79.6583 | 43.5789 Bogotá | N/A | Colombia | -74.08175 | 4.60971 Kowloon | N/A | Hong Kong | 114.18333 | 22.31667 Tamil Nadu | N/A | India | N/A | N/A Udine | N/A | Italy | 13.23715 | ...
0
NCT00168298
[ 3 ]
129
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of this study is to determine whether donepezil HCl is effective and safe in improving cognitive dysfunction exhibited by children and adolescents with Down syndrome (DS). Effectiveness will be measured by rating communication, daily living skills, and social skills and relationships in subjects aged 10 to ...
null
Down Syndrome
Down Syndrome trisomy 21
null
2
arm 1: None arm 2: None
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Blinded donepezil 2.5 milligram per day (mg/day) (2.5 milliliter per day \[mL/day\]) orally for participants with body weight (BW) 20 and less than (\<) 25 kilogram (kg), 5 mg/day (5 mL/day) orally for participants with BW 25 to \<50 kg, and 10 mg/day (10 mL/day) orally for participants with BW greater ...
intervention 1: Donepezil HCl intervention 2: Placebo
31
Phoenix | Arizona | United States | -112.07404 | 33.44838 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Los Angeles | California | United States | -118.24368 | 34.05223 Oakland | California | United States | -122.2708 | 37.80437 Orange | California | United States | -117.85311 | 33.78779 San Diego | Cal...
0
NCT00570128
[ 3 ]
54
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
1FEMALE
false
The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after abdominal hysterectomy surgery.
Hysterectomy is the second most common surgery among women in the United States (US). According to the National Center for Health Statistics, there were 617,000 hysterectomies performed in the US in 2004. Effective postoperative pain management after hysterectomy is important in ensuring that surgical subjects have a s...
Postoperative Pain
Post Operative Pain Hysterectomy
null
3
arm 1: A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure arm 2: A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure arm 3: The patient will recieve the standard of care, but no implant during surgery
[ 0, 2, 4 ]
2
[ 0, 0 ]
intervention 1: The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed bet...
intervention 1: Bupivacaine Collagen Sponge (CollaRx®) intervention 2: placebo
1
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
0
NCT00624910
[ 3 ]
183
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
Efficacy study of ecabet ophthalmic solution in dry eye disease
null
Dry Eye Disease
null
2
arm 1: ecabet ophthalmic solution arm 2: Placebo comparator
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: sterile ophthalmic solution intervention 2: sterile ophthalmic solution
intervention 1: ecabet ophthalmic solution intervention 2: placebo
1
Irvine | California | United States | -117.82311 | 33.66946
0
NCT00667004
[ 3 ]
5
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
RATIONALE: Giving chemotherapy before a donor bone marrow transplant or peripheral stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain stem cells from a donor are infused into the patient they may help the patient's bo...
OBJECTIVES: Primary * To determine the incidence of grade II-IV acute graft-versus-host disease in patients with hematologic cancer or other diseases treated with a myeloablative conditioning regimen comprising targeted (steady-state concentration of 800-1,000 ng/mL) busulfan, cyclophosphamide, and anti-thymocyte glo...
Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Secondary Myelofibrosis
graft versus host disease adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) recurrent adult acute myeloi...
null
1
arm 1: Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
[ 0 ]
14
[ 2, 0, 0, 0, 0, 6, 6, 10, 10, 10, 10, 3, 3, 3 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None intervention 9: None intervention 10: None intervention 11: None intervention 12: None intervention 13: None intervention 14: None
intervention 1: anti-thymocyte globulin intervention 2: busulfan intervention 3: cyclophosphamide intervention 4: mycophenolate mofetil intervention 5: tacrolimus intervention 6: polymerase chain reaction intervention 7: polymorphism analysis intervention 8: flow cytometry intervention 9: laboratory biomarker analysis ...
1
Omaha | Nebraska | United States | -95.94043 | 41.25626
0
NCT00611351
[ 4 ]
180
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
null
The primary objective of the study was to assess the long-term safety of 30- and 60-mg daily doses of ospemifene in the treatment of Vulvar and Vaginal Atrophy (VVA) in postmenopausal women with an intact uterus.
null
Atrophy Vaginal Diseases
Menopausal symptoms Urogenital atrophy Vulvar and vaginal atrophy in menopausal women Vaginal atrophy
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: Ospemifene (Dose 1) intervention 2: Ospemifene (Dose 2) intervention 3: Placebo
0
null
0
NCT01585558
[ 3 ]
627
RANDOMIZED
PARALLEL
0TREATMENT
null
false
0ALL
false
This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.
A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder Twice Daily compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Persi...
Asthma
Adolescents Adults Asthma Pharmacokinetics Pharmacogenetics GW685698X
null
1
arm 1: GW685698X
[ 0 ]
1
[ 0 ]
intervention 1: GW685698X
intervention 1: GW685698X
154
Phoenix | Arizona | United States | -112.07404 | 33.44838 Fort Smith | Arkansas | United States | -94.39855 | 35.38592 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Fresno | California | United States | -119.77237 | 36.74773 Granada Hills | California | United States | -118.52314 | 34.26472 Huntington B...
1
NCT00603746
[ 3 ]
29
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This study will evaluate the efficacy and safety of LBH589B in adult patients with chronic phase chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors
null
Chronic Myeloid Leukemia in Chronic Phase
Refractory Chronic Myeloid Leukemia in Chronic Phase adults oral LBH589
null
1
arm 1: Participants were administered panobinostat 20 milligram (mg) orally once a day (OD) three times a week as part of a 4 week (28 day) treatment cycle. Panobinostat were administered at the same time each morning with 8oz/240 milliliter (ml) of water after a fasting period of at least two hours (water was allowed)...
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: LBH589
10
Brussels | N/A | Belgium | 4.34878 | 50.85045 Godinne | N/A | Belgium | 4.87364 | 50.34809 Leuven | N/A | Belgium | 4.70093 | 50.87959 Cologne | N/A | Germany | 6.95 | 50.93333 Düsseldorf | N/A | Germany | 6.77616 | 51.22172 Hamburg | N/A | Germany | 9.99302 | 53.55073 Leipzig | N/A | Germany | 12.37129 | 51.33962 Main...
0
NCT00451035
[ 4 ]
882
null
PARALLEL
0TREATMENT
null
false
0ALL
null
The objective of this study is to demonstrate the safety and efficacy of tipranavir/ritonavir versus an active control arm in highly treatment experienced Human immunodeficiency virus-1 infected patients. Patients must have a viral load \> =1000 cells/mL, and genotype indicating at least one resistance conferring prote...
null
HIV Infections
null
2
arm 1: None arm 2: None
[ 5, 5 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Tipranavir (with low dose ritonavir) intervention 2: Comparator protease inhibitor(CPI)/low dose ritonavir(r)
174
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | ...
1
NCT00144170
[ 4 ]
504
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This is an, open-label, long-term safety extension for patients in North America who have completed the prior istradefylline study 6002-INT-001.
Patients with Parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind study 6002-INT-001 are eligible to enter into this long-term open safety study with a starting istradefylline dose of 20 or 40mg per day.
Parkinson's Disease
Parkinson's Disease levodopa end of dose wearing off OFF time
null
1
arm 1: Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
[ 0 ]
1
[ 0 ]
intervention 1: Oral istradefylline (KW-6002) 20 or 40 mg once daily.
intervention 1: Istradefylline
1
Princeton | New Jersey | United States | -74.65905 | 40.34872
1
NCT00199381
[ 3 ]
70
NON_RANDOMIZED
SINGLE_GROUP
1PREVENTION
0NONE
false
0ALL
false
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.
This is a Phase II open-label, multi-center conversion study in stable, adult kidney transplant recipients to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosu...
Kidney Transplantation
Pharmacokinetics Therapy Immunosuppression Drugs, Investigational Adult
null
1
arm 1: Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous ...
[ 0 ]
2
[ 0, 0 ]
intervention 1: Oral intervention 2: Oral
intervention 1: Tacrolimus Modified Release (MR) intervention 2: tacrolimus
9
San Diego | California | United States | -117.16472 | 32.71571 Miami | Florida | United States | -80.19366 | 25.77427 Minneapolis | Minnesota | United States | -93.26384 | 44.97997 Cincinnati | Ohio | United States | -84.51439 | 39.12711 Portland | Oregon | United States | -122.67621 | 45.52345 Madison | Wisconsin | Un...
1
NCT00282568
[ 4 ]
565
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this clinical research study is to learn whether Saxagliptin added to thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD alone
All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requ...
Diabetes Mellitus, Type 2
null
3
arm 1: Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication) arm 2: Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication) arm 3: Placebo PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as r...
[ 0, 0, 2 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: Tablets, Oral, 2.5 mg, Once daily (6 months ST, 12 months LT) intervention 2: Tablets, Oral, 5 mg, once daily (6 months ST, 12 months LT) intervention 3: Tablets, Oral, 0 mg, Once daily (6 months ST, 12 months LT) intervention 4: Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT) inte...
intervention 1: Saxagliptin intervention 2: Saxagliptin intervention 3: Placebo intervention 4: pioglitazone intervention 5: rosiglitazone intervention 6: metformin
133
Haleyville | Alabama | United States | -87.62141 | 34.22649 Mobile | Alabama | United States | -88.04305 | 30.69436 Ozark | Alabama | United States | -85.64049 | 31.45906 Mesa | Arizona | United States | -111.82264 | 33.42227 Jonesboro | Arkansas | United States | -90.70428 | 35.8423 Little Rock | Arkansas | United Sta...
1
NCT00295633
[ 4 ]
2,053
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
null
Pulmonary Safety in Diabetics with T/I
null
Diabetes, Type 1 Diabetes, Type 2
null
3
arm 1: Technosphere® Insulin Inhalation Powder arm 2: Usual care arm 3: Subjects without abnormalities in glucose control (Note: Hypoglycemia and HbA1c were not reported for this group)
[ 0, 5, 4 ]
2
[ 0, 0 ]
intervention 1: Inhalation, 15U/30U intervention 2: Subjects will receive antidiabetes treatment at the discretion of their physicians
intervention 1: Technosphere® Insulin Inhalation Powder intervention 2: Usual Care
176
Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Tempe | Arizona | United States | -111.90931 | 33.41477 Tucson | Arizona | United States...
1
NCT00308737
[ 4 ]
504
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.
null
Atrial Fibrillation
Atrial Fibrillation sinus rhythm amiodarone
null
2
arm 1: dronedarone 400mg tablets administered twice a day (bid) and matching over-encapsulated tablets of placebo of amiodarone 200mg arm 2: over-encapsulated tablets of amiodarone 200mg (600mg daily for 28 days then 200mg daily) administered once daily (od) and matching placebo of dronedarone 400mg tablets
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: oral administration intervention 2: oral administration
intervention 1: dronedarone (SR33589) intervention 2: amiodarone
23
Bridgewater | New Jersey | United States | -74.64815 | 40.60079 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Cove | N/A | Australia | N/A | N/A Vienna | N/A | Austria | 16.37208 | 48.20849 Diegem | N/A | Belgium | 4.43354 | 50.89727 Laval | N/A | Canada | -73.692 | 45.56995 Santiago | N/A | Chile | -70.64827 ...
1
NCT00489736
[ 2 ]
16
NA
SINGLE_GROUP
5SCREENING
0NONE
false
0ALL
false
The purpose of this pilot study is to determine whether there is a correlation between viral load reduction (at Day 4, 7 or 14) following a short course (14 days) of Maraviroc added to a failing regimen, and the R5 result of the TrofileTM assay at screening.
The study A4001060 has been discontinued on April 22, 2008. A review of the poor rate of enrollment has projected difficulties in completing the study in a timely manner, despite the best efforts by the sponsor and the sites. Given the difficulties encountered in this pilot study and the need to conduct an even larger ...
HIV Infections
Treatment Experienced
null
1
arm 1: None
[ 5 ]
2
[ 0, 3 ]
intervention 1: Treatment-experienced subjects on failed therapy, with HIV RNA ≥ 1000 copies/mL, are eligible who will receive a tropism assay at screening (Day -14 to 0). Subjects who are eligible will receive maraviroc added to a failing regimen from Day 1 to 14. On day 15, subjects will discontinue the current treat...
intervention 1: maraviroc intervention 2: Trofile Assay and HIV RNA quantification assay
10
Miami | Florida | United States | -80.19366 | 25.77427 Chicago | Illinois | United States | -87.65005 | 41.85003 Topeka | Kansas | United States | -95.67804 | 39.04833 Topeka | Kansas | United States | -95.67804 | 39.04833 Detroit | Michigan | United States | -83.04575 | 42.33143 Omaha | Nebraska | United States | -95....
1
NCT00496782