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Ulcerative Colitis clinical trials

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NCT ID: NCT00259571 Withdrawn - Ulcerative Colitis Clinical Trials

Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.

Start date: n/a
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate if retarded phosphatidylcholine is as effective as mesalazin in preventing an acute episode in ulcerative colitis. The hypothesis is, that ulcerative colitis is cuased by a defect in the barrier function of the colonic mucus. The background of the study is the finding that the phosphatidylcholine content of the colonic mucus is reduced in patients with ulcerative colitis, in both healthy and inflamed parts of the colon.

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: NCT00254618 Terminated - Ulcerative Colitis Clinical Trials

A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis.

Start date: October 2005
Phase: Phase 1
Study type: Interventional

The purpose of this randomized, open-label, parallel-group study is to determine how the body absorbs and eliminates mesalamine following administration of either 30 mg/kg/day, 60 mg/kg/day or 90 mg/kg/day as 400 mg delayed-release tablets given every 12 hours of 28 days to children and adolescents with active ulcerative colitis.

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: NCT00213330 Withdrawn - Ulcerative Colitis Clinical Trials

Cerebral Resonance Magnetic Imaging During Rectal Distention

Start date: April 2003
Phase: N/A
Study type: Observational

Irritable bowel syndrome is responsible for chronic abdominal pain, diarrhea and/or constipation. It is a very frequent problem. However, the exact cause of irritable bowel syndrome remains unknown. The purpose of this study is to look for a different cerebral response by magnetic resonance imaging after rectal stimulation in patients with irritable bowel syndrome compared to healthy subjects and to patients with digestive organic disease. Our hypothesis is that irritable bowel syndrome could be a problem of cerebral integration of visceral stimulation.

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.