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Colitis clinical trials

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NCT ID: NCT00790933 Completed - Ulcerative Colitis Clinical Trials

An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease

GEMINI LTS
Start date: May 22, 2009
Phase: Phase 3
Study type: Interventional

The purpose of this multicenter, open-label study is to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.

NCT ID: NCT00790478 Terminated - Ulcerative Colitis Clinical Trials

Melatonin and Ulcerative Colitis: A Pilot Clinical Trial

Start date: January 2009
Phase: Phase 2
Study type: Interventional

Ulcerative colitis is an inflammatory bowel disease that afflicts up to one million people in the U.S. Symptoms include rectal urgency, bloody diarrhea, moderate to severe abdominal pain, fever, and fatigue. Melatonin is a hormone that is associated with sleep and other body functions that may be related to health. Melatonin is produced in the pineal gland and, in fact, it is produced in even greater amounts in the gut. Melatonin appears to be important in gastrointestinal tract physiology and health, and data from cell and animal experiments, and some studies in humans, suggest that supplemental melatonin may help ameliorate colitis. Given that current treatments for ulcerative colitis are not always effective, and often have serious side effects, there is considerable interest in finding alternative treatments for this disease. However, experimental data on the ability of melatonin to improve ulcerative colitis in humans are lacking. To address this, we plan to conduct a pilot clinical trial (60 adult male and female participants) that will obtain preliminary data about the effectiveness of melatonin supplementation as a treatment for ulcerative colitis in adult men and women with the disease. The "Melatonin and Ulcerative Colitis" study funded by a grant from the Broad Foundation's Broad Medical Research Program (http://www.broadmedical.org).

NCT ID: NCT00787202 Completed - Ulcerative Colitis Clinical Trials

A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.

Start date: December 2008
Phase: Phase 2
Study type: Interventional

The hypothesis of the study is that at least one dose of CP 690 550 is superior to placebo (inactive drug) in inducing remission in patients with moderate to severe ulcerative colitis.

NCT ID: NCT00783718 Completed - Ulcerative Colitis Clinical Trials

Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis

GEMINI I
Start date: January 2009
Phase: Phase 3
Study type: Interventional

The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.

NCT ID: NCT00781638 Completed - Ulcerative Colitis Clinical Trials

ADAPT Adacolumn Pediatric Trial in Ulcerative Colitis

Start date: October 2008
Phase: N/A
Study type: Interventional

Children aged up to 18 years with moderately active Ulcerative Colitis (PUCAI:35-64) will receive one weekly Adacolumn® apheresis treatment over 5 consecutive weeks, followed by up to 3 optional Adacolumn® apheresis treatments over 3 consecutive weeks. Primary end point is PUCAI at Week 12. The main part of the clinical investigation will be continued by a one year follow up for responders.

NCT ID: NCT00780507 Completed - Ulcerative Colitis Clinical Trials

Fecal Biomarker Study for Patients With Ulcerative Colitis

Start date: August 2007
Phase: Phase 3
Study type: Observational

The present study will analyze fecal levels of FC and FL in UC patients who relapse (flare) while on a QD or a BID Asacol treatment regimen and compare those levels to levels of FC and FL in UC patients who do not relapse (flare).

NCT ID: NCT00767728 Completed - Ulcerative Colitis Clinical Trials

Mesalamine Pellet to Maintain Remission of Mild to Moderate Ulcerative Colitis

Start date: December 2004
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the maintenance of mild to moderate ulcerative colitis remission with six months of treatment with 1.5 grams of mesalamine pellets each day versus placebo.

NCT ID: NCT00751933 Terminated - Ulcerative Colitis Clinical Trials

Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis

Start date: October 2008
Phase: Phase 2
Study type: Interventional

Ulcerative colitis is a chronic inflammatory bowel disease caused by an imbalance between natural defence mechanisms in the intestinal mucosa and microbes in the intestinal lumen. We hypothesise that an improvement or even normalisation of this balance may be achieved by the use of vaccines and dietary oats. The combined use of oral typhoid vaccine and cholera/ETEC-vaccine is supposed to stimulate mucosal defence factors, while dietary oats modifies the microbial environment inside the intestinal lumen. Or study aim is to show if such treatment brings symptom relief to patients with ulcerative colitis.

NCT ID: NCT00748410 Terminated - Colitis, Ulcerative Clinical Trials

Study to Evaluate the Pharmacodynamics of SB-656933 in Patients With Ulcerative Colitis

Start date: January 22, 2009
Phase: Phase 2
Study type: Interventional

This study will involve the use of a new compound, SB-656933. Accumulation of inflammatory white blood cells (mostly polymorphonuclear neutrophils)in the gut (colon) may be contributing to the pathology of ulcerative colitis. It has been shown that SB-656933 reduces polymorphonuclear neutrophils (PMN) accumulation in pre-clinical models of colitis. 99m-Tc-HMPAO scintigraphy is a imaging technique which will be used in this study to observe the effect of SB656933 on the migration of PMN to inflamed tissue.

NCT ID: NCT00747110 Completed - Colitis, Ulcerative Clinical Trials

Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC)

Start date: October 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to prove the therapeutic equivalence and safety of once-daily 9 mg budesonide versus 3 g mesalazine in a 8-week treatment in patients with active ulcerative colitis.