Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.

Last updated: December 12, 2013
Sponsor: Heidelberg University
Overall Status: Trial Not Available

Phase

2/3

Condition

Ulcers

Inflammatory Bowel Disease

Ulcerative Colitis

Treatment

N/A

Clinical Study ID

NCT00259571
PC4
BFARM - 402 2918
EC - L389/2003
  • Ages 15-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Start date:
Estimated Completion Date:
March 31, 2010

Connect with a study center

  • Medical Hospital - University of Heidelberg

    Heidelberg, 69120
    Germany

    Site Not Available

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