Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.

Ulcerative Colitis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00259571
• Other study ID #: PC4
• Secondary ID: EC - L389/2003BF
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: November 28, 2005
• Last updated: December 12, 2013
• Est. completion date: March 2010

Study information

• Verified date: November 2005
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• retarded release phosphatidylcholine
2g daily, given orally QTD

Locations

Country	Name	City	State
Germany	Medical Hospital - University of Heidelberg	Heidelberg

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	Dietmar Hopp Stiftung

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Stremmel W, Merle U, Zahn A, Autschbach F, Hinz U, Ehehalt R. Retarded release phosphatidylcholine benefits patients with chronic active ulcerative colitis. Gut. 2005 Jul;54(7):966-71. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of relapses
Primary	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	time to the first relapse
Secondary	amount of relapses per year
Secondary	endoscopic index
Secondary	histolgical score
Secondary	life quality
Secondary	side effects