Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis
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|ClinicalTrials.gov Identifier: NCT00259545|
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : June 5, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis Phosphatidylcholine||Drug: Retarded Release Phosphatidylcholine (rPC)||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prospektive, Randomisierte Doppelblinde Studie Zur Wirksamkeit Von Intestinal Retardiert Freigesetztem Phosphatidylcholine Bei therapierefraktärer Colitis Ulcerosa Mit Chronisch Aktivem Verlauf Unter Corticosteroiden|
|Study Start Date :||February 2003|
|Study Completion Date :||February 2006|
- complete steroid reduction
- remission, life quality, clinical indices, endoscopic indices, histological score, subgroup analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259545
|University Heidelberg - Medical Department 4 - Gastroenterology|
|Heidelberg, Germany, 69120|
|Principal Investigator:||Wolfgang Stremmel, Professor||Heidelberg University|