Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.
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.
|Ulcerative Colitis||Drug: retarded release phosphatidylcholine||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Prospektive, Randomisierte, Doppelblinde, Mesalazin-kontrollierte ("Double-dummy Verfahren) Multizenter-Studie Zur Beurteilung Der Annahme Der äquivalenten Wirkung Von Intestinal Retardiert Freigesetztem Phosphatidylcholin gegenüber Mesalazin (Non-inferiority Study) in Der Remissionserhaltung Der Colitis Ulcerosa.|
- rate of relapses
- relapse is defined as an increase of the clinical Rachmilewitz index to 5 or more, but at least 3 points over a period of 14 days
- time to the first relapse
- amount of relapses per year
- endoscopic index
- histolgical score
- life quality
- side effects
|Estimated Study Completion Date:||March 2010|
Drug: retarded release phosphatidylcholine
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259571
|Medical Hospital - University of Heidelberg|
|Heidelberg, Germany, 69120|
|Principal Investigator:||Wolfgang Stremmel, Professor||Heidelberg University|