Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis
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.
Drug: Retarded Release Phosphatidylcholine (rPC)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Prospektive, Randomisierte Doppelblinde Studie Zur Wirksamkeit Von Intestinal Retardiert Freigesetztem Phosphatidylcholine Bei therapierefraktärer Colitis Ulcerosa Mit Chronisch Aktivem Verlauf Unter Corticosteroiden|
- complete steroid reduction
- remission, life quality, clinical indices, endoscopic indices, histological score, subgroup analysis
|Study Start Date:||February 2003|
|Estimated Study Completion Date:||February 2006|
Design: Prospective, randomized, placebo-controlled, double-blinded study.
Population: 60 patients with chronic active ulcerative colitis and steroid dependency
Inclusion: Chronic active ulcerative colitis, clinical index 5 or more, endoscopic Index 5 or more, steroid dependent course since at least 4 months.
Main criteria: complete steroid reduction
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259545
|University Heidelberg - Medical Department 4 - Gastroenterology|
|Heidelberg, Germany, 69120|
|Principal Investigator:||Wolfgang Stremmel, Professor||Heidelberg University|