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Ulcerative Colitis clinical trials

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NCT ID: NCT00274209 Completed - Ulcerative Colitis Clinical Trials

Chromoendoscopy for Ulcerative Colitis Surveillance

Start date: December 2005
Phase: N/A
Study type: Observational

Long-standing ulcerative colitis is associated with an increased cancer risk. Chromoendoscopy with dye spraying can detect subtle abnormalities that are not visible with standard endoscopy. The purpose of this study is to determine if chromoendoscopy with fewer "targeted biopsies" can replace standard colonoscopy with multiple "random" biopsies.

NCT ID: NCT00269438 Completed - Ulcerative Colitis Clinical Trials

New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis

Start date: December 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to establish the efficacy and safety of a new tablet formulation and dosing regimen of balsalazide disodium dosed twice daily in achieving clinical improvement in subjects with mildly to moderately active ulcerative colitis after 8 weeks of therapy.

NCT ID: NCT00261118 Completed - Ulcerative Colitis Clinical Trials

Rituximab in Active Ulcerative Colitis

Start date: April 2004
Phase: Phase 2/Phase 3
Study type: Interventional

There is broad support for the hypothesis that Ulcerative colitis is an auto-immune disease. Rituximab is an antibody protein that removes a subgroup of white blood cells (B lymphocytes) from the circulation. These cells have the capacity to generate the auto-antibodies that typify auto-immune disease. Although Rituximab has been mainly used for treating B lymphocyte malignancies (lymphoma) it has also been used with promising results in Rheumatoid arthritis and has an excellent safety record. This is a small placebo-controlled trial to assess its efficacy and safety in patients with steroid-resistant active ulcerative colitis.

NCT ID: NCT00259558 Completed - Ulcerative Colitis Clinical Trials

Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis

Start date: April 2003
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find the optimal dose of retarded release Phosphatidylcholine in the most severe form of ulcerative colitis. The hypothesis is that ulcerative colitis (UC) is caused by a barrier dysfunction of the colonic mucus layer. The background of the study is the finding, that the phosphatidylcholine (PC) content of the colonic mucus is strongly reduced in UC compared to healthy controls and patients with Crohn´s disease. The content was meuasured in non-inflamed areas of the colon in UC. Thus, we evaluate whether a substitution of colonic PC is an effective method.

NCT ID: NCT00259545 Completed - Ulcerative Colitis Clinical Trials

Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis

Start date: February 2003
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate if retarded release phosphatidylcholine is an effective alternative to steroid dependent or -refractory course in chronic active ulcerative colitis. The hypothesis is, that ulcerative colitis is caused by a barrier defect of the colonic mucus layer. The background of the study is the finding, that the phosophatidylcholine content of the colonic mucus is strongly reduced in ulcerative colitis (UC) compared to healthy controls and patients with Crohn´s disease. The content was measured in non-inflamed areas of the colon in UC. Thus, we evaluate whether a substitution of colonic PC is an effective method for steroid dependent UC. See: Gut. 2005 Jul;54(7):966-71. Stremmel et al.

NCT ID: NCT00232258 Completed - Ulcerative Colitis Clinical Trials

Nolpitantium Besylate In Patients With Ulcerative Colitis a Double-Blind, Placebo Controlled Efficacy and Safety Study

NICE
Start date: April 2005
Phase: Phase 2
Study type: Interventional

To evaluate the safety and efficacy on clinical symptoms, mucosal histology and endoscopic mucosal appearance of two doses of SR140333B against placebo in patients with mild to moderate ulcerative colitis resistant to treatment with 5-ASA.

NCT ID: NCT00222378 Completed - Ulcerative Colitis Clinical Trials

Prevalence of Cytomegalovirus, Epstein Barr Virus and Human Herpes 6 Virus in Inflammatory Bowel Disease

Start date: April 2005
Phase: N/A
Study type: Observational

An increase prevalence of CMV, EBV and or HHV-6 in diseased tissue of inflammatory bowel disease would suggest a role for these viruses in the etiology and/or exacerbation of IBD, whereas their absence would preclude such association.

NCT ID: NCT00219414 Completed - Ulcerative Colitis Clinical Trials

Study for the Treatment of Ulcerative Colitis With Adacolumn (Companion to US Study 512-04-205)

Start date: June 2005
Phase: Phase 4
Study type: Interventional

The purpose of the study is to demonstrate the safety and effectiveness of the Adacolumn Apheresis System to treat the signs and symptoms of ulcerative colitis.

NCT ID: NCT00215020 Completed - Ulcerative Colitis Clinical Trials

Evaluation of Urinary Isoprostanes in the Assessment of Children With Inflammatory Bowel Disease

Start date: September 2003
Phase: Phase 1
Study type: Observational

Isoprostanes are compounds that are produced as a result of oxidative damage to cell membranes. Elevated tissue, serum, and urinary isoprostane levels have been described in a number of inflammatory diseases. The goal of this study is to determine utility of measuring urinary isoprostane levels in pediatric patients with inflammatory and non-inflammatory gastrointestinal disease. Urine samples will be collected from pediatric patients undergoing procedures in the Children's Hospital endoscopy unit. Clinical disease activity will be assessed using a standardized clinical disease activityiIndex. Gross endoscopic and histologic findings will be graded. Previously obtained laboratory studies will also be recorded. Urinary Isoprostane levels will be determined using a commercially available assay. Isoprostane levels will be compared across conditions (IBD vs. non-inflammatory, Crohn's disease vs. ulcerative colitis) and tested for statistical significance. Similarly, disease severity and urinary isoprostane levels will be assessed. The sensitivity, specificity, and positive and negative predictive values of elevated urinary isoprostane levels at discriminating pediatric patients with inflammatory and non-inflammatory gastrointestinal disease will be calculated.

NCT ID: NCT00209300 Completed - Ulcerative Colitis Clinical Trials

Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission

Start date: May 2005
Phase: Phase 3
Study type: Interventional

This is a multi-centre, randomised, controlled, investigator blinded study. The randomisation will be done centrally. The patients will be treated for 1 year, with clinical and laboratory assessments at 0, 4, 8 and 12 months. Endoscopic examination is at enrollment and on completion of the study (at relapse or after 12 months). Number of Subjects (Planned and Analysed): - 360 patients for demonstration of non-inferiority between once daily and twice daily; - 326 to be analysed in per-protocol (PP) analyses; and - 360 in intention-to-treat (ITT) analyses.