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NCT ID: NCT01039688 Completed - Clinical trials for Arthritis, Rheumatoid

Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX

ORAL1069
Start date: January 2010
Phase: Phase 3
Study type: Interventional

This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This study will also compare the safety of CP-690,550 with methotrexate.

NCT ID: NCT01035255 Completed - Clinical trials for Heart Failure With Reduced Ejection Fraction

This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure

PARADIGM-HF
Start date: December 2009
Phase: Phase 3
Study type: Interventional

The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =< 35%).

NCT ID: NCT01032629 Completed - Clinical trials for Diabetes Mellitus, Type 2

CANVAS - CANagliflozin cardioVascular Assessment Study

CANVAS
Start date: December 9, 2009
Phase: Phase 3
Study type: Interventional

The study will assess canagliflozin (JNJ-28431754) in the treatment of patients with type 2 diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac events (MACE). Other objectives include evaluating the overall safety, tolerability, and effectiveness of canagliflozin. The data from this study will be combined with the data from CANVAS-R study (Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects with T2DM, NCT01989754) in a pre-specified integrated analysis of CV safety outcomes to satisfy US FDA post-marketing requirements for canagliflozin.

NCT ID: NCT01030614 Completed - Postoperative Pain Clinical Trials

Dexamethasone Improves Postoperative Symptoms After Laparoscopic Cholecystectomy

dxt
Start date: January 2007
Phase: Phase 3
Study type: Interventional

Dexamethasone has been reported to reduce postoperative nausea and vomiting (PONV) after laparoscopic cholecystectomy (LC). However, its effects on other surgical outcomes such as pain and fatigue have been unclear. We evaluated the efficacy of preoperative dexamethasone in ameliorating postoperative symptoms after LC. Methods: Prospective, double-blind, placebo-controlled study, 210 patients scheduled for elective LC were analyzed after randomization to intravenous dexamethasone (8 mg) or to a placebo. All patients underwent standardized procedures for general anesthesia and surgery. Episodes of PONV and pain and fatigue scores were recorded on a visual analogue scale. Analgesic and antiemetic requirements were also recorded.

NCT ID: NCT01029886 Completed - Clinical trials for Type 2 Diabetes Mellitus

Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes

Start date: January 2010
Phase: Phase 3
Study type: Interventional

No head to head comparisons between exenatide once weekly and liraglutide have been performed. Therefore, the purpose of this study is to compare exenatide once weekly to once-daily liraglutide with regard to HbA1c, body weight, subject-reported outcomes, and other clinical benefits. The study includes a 26-week treatment period and a safety follow-up visit 10 weeks after the final study drug dose.

NCT ID: NCT01029652 Completed - Acute Gout Clinical Trials

Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicine Including a 12 Weeks Extension and an Open-label 48 Weeks Extension Study

ß-RELIEVED
Start date: December 2009
Phase: Phase 3
Study type: Interventional

The purpose of the 12-week core study was to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent flares of gout for whom non-steroidal anti-inflammatory drugs (NSAIDs) and/ or colchicine are contraindicated, not tolerated, or ineffective. The efficacy of canakinumab was compared to the corticosteroid triamcinolone acetonide. The purpose of the first 12-week extension study was to collect additional safety, tolerability and efficacy data in patients who have completed the core study CACZ885H2356. The purpose of the second 48 week open-label extension study was to collect additional long-term safety and tolerability data in patients who have completed the first extension study CACZ885H2356E1.

NCT ID: NCT01029405 Completed - Psoriasis Clinical Trials

Safety and Efficacy Study of a Novel Ointment to Treat Plaque Type Psoriasis

AN2728PSR203
Start date: November 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of AN2728 Ointment B, 2.0% and 0.5%, compared to Ointment Vehicle B, applied once or twice daily for 12 weeks, in the treatment of plaque type psoriasis

NCT ID: NCT01028807 Completed - Early Feeding Clinical Trials

Early Feeding vs 5-day Fasting After Distal Elective Bowel Anastomoses in Children. A Randomized Controlled Trial

Start date: June 2003
Phase: N/A
Study type: Interventional

Purpose: To determine the safety and efficacy of early enteral feeding after distal (ileum-colon) elective bowel anastomoses in children. Methods: Controlled randomized trial including all pediatric patients with distal elective bowel anastomosis, excluding non-elective and high risk patients. VARIABLES: Demographic characteristics, operative time, anastomosis placement, Follow up: Tolerability variables: beginning peristalsis, beginning bowel movement, time to full diet intake, post-operative stay. Safety variables: mild and persistent vomiting, persistent abdominal distention, wound infection or dehiscence as well as anastomotic leak or dehiscence, reoperation and death. At the end of surgery were randomized to: 1. Experimental group(EG): Early feeding group, after a 24 hours fasting period, with good abdominal conditions (once the post operative ileus had solved), oral fluids and diet was started. 2. Control group (CG): obligatory 5-day fasting. Once the regular diet was tolerated, the patients were discharged. Statistics: Descriptive statistics for global description. Student's t test for quantitative variables and Chi square test for qualitative variables, a p-value less than 0.05 was considered statistically significant.

NCT ID: NCT01028690 Active, not recruiting - Clinical trials for Helicobacter Pylori Infection

Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri

Start date: December 2009
Phase: N/A
Study type: Interventional

Helicobacter pylori colonizes approximately to 50% of the world-wide population. There is an exigency to find routes alternating to control the infection with an ample perspective but without the complications of induction of resistance to antibiotics. Supplement dietetic with Lactobacillus reuteri (L. reuteri) in humans takes to the colonization of epithelium gastric and this, combined with the observation of which L. reuteri has the capacity to inhibit the growth of H. Pylori and its union to the gastric mucosa, indicates the potential that the native human bacteria control and influence in the colonization in humans. The acid-lactic bacteria (in particular the lactobacillus) have been studied by their effects in humans infected with H. Pylori with some success to reduce the load of bacteria Studies using supplements with L. reuteri as much in infected symptomatic patients as asymptomatic with H. pylori showed a clear reduction of the load of bacteria after 4 weeks of use and this was concordant with a reduction in the symptoms associated to the infection.

NCT ID: NCT01027949 Completed - Clinical trials for Pulmonary Arterial Hypertension

An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial Hypertension

FREEDOM-EXT
Start date: January 16, 2007
Phase: Phase 3
Study type: Interventional

This study provided/continued to provide oral treprostinil (UT-15C SR; treprostinil diethanolamine) to eligible subjects who participated in Studies TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, and TDE-PH-308. The study assessed the long term safety of oral treprostinil and the effect of continued treatment with oral treprostinil on exercise capacity after 1 year of treatment.