NCT00259571

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.

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 15 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	retarded release phosphatidylcholine	2g daily, given orally QTD

Timeline

• Completion: 2010-03-01
• First posted: 2005-11-29
• Last updated: 2013-12-13

Locations

1 site across 1 country: Germany