Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.
Phase 2
Withdrawn
- Conditions
- Ulcerative Colitis
- Registration Number
- NCT00259571
- Lead Sponsor
- Heidelberg University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- diagnosis of ulcerative colitis in remission (CAI 3 or less)
- signed letter of content
- no steroids or immunosupressants in the last 6 weeks
- at least 5 relapses in the last 3 years
- last relapse was 8 months ago or less
- complete colonoscopy at entry
Exclusion Criteria
- pregnancy or breast feeding
- steroids or immunosuppressants
- acute episode of UC
- condition after complete or partial colektomy
- known intolerance to mesalazin
- severe medical disease other than colitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method time to the first relapse endoscopic index life quality side effects amount of relapses per year histolgical score
Trial Locations
- Locations (1)
Medical Hospital - University of Heidelberg
🇩🇪Heidelberg, Germany