NCT00259571WithdrawnPhase 2
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.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Heidelberg University
- Locations
- 2
- Primary Endpoint
- rate of relapses
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 15 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
- time to the first relapse
- endoscopic index
- life quality
- side effects
- amount of relapses per year
- histolgical score
Investigators
Study Sites (2)
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