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| Sponsors and Collaborators: |
University of Heidelberg Professor Wolfgang Stremmel Dietmar Hopp Stiftung |
|---|---|
| Information provided by: | University of Heidelberg |
| ClinicalTrials.gov Identifier: | NCT00259545 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Ulcerative Colitis Phosphatidylcholine |
Drug: Retarded Release Phosphatidylcholine (rPC) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Prospektive, Randomisierte Doppelblinde Studie Zur Wirksamkeit Von Intestinal Retardiert Freigesetztem Phosphatidylcholine Bei therapierefraktärer Colitis Ulcerosa Mit Chronisch Aktivem Verlauf Unter Corticosteroiden |
| Estimated Enrollment: | 60 |
| 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
Eligibility| Ages Eligible for Study: | 16 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| University Heidelberg - Medical Department 4 - Gastroenterology | |
| Heidelberg, Germany, 69120 | |
| Principal Investigator: | Wolfgang Stremmel, Professor | University of Heidelberg |
More Information
| Study ID Numbers: | PC2, EC - L71/2003, BFARM - 402 29 17 |
| Study First Received: | November 25, 2005 |
| Last Updated: | June 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00259545 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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retarded phosphatidylcholine chronic active steroid |
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Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases Inflammatory Bowel Diseases |
Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |
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Pathologic Processes |
