Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.

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.

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.

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