Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.

Heidelberg University

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: retarded release phosphatidylcholine

Study type: Interventional

Funder types: Other

Identifiers

NCT00259571

PC4

EC - L389/2003

BFARM - 402 2918

Details and patient eligibility

About

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.

Sex: All

Ages: 15 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind