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Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.

This study has been withdrawn prior to enrollment.
(Missing financial sponsorship)
Dietmar Hopp Stiftung
Information provided by:
Heidelberg University Identifier:
First received: November 28, 2005
Last updated: December 12, 2013
Last verified: November 2005

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.

Condition Intervention Phase
Ulcerative Colitis Drug: retarded release phosphatidylcholine Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
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.

Resource links provided by NLM:

Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • rate of relapses
  • 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 Outcome Measures:
  • time to the first relapse
  • amount of relapses per year
  • endoscopic index
  • histolgical score
  • life quality
  • side effects

Enrollment: 0
Estimated Study Completion Date: March 2010
Intervention Details:
    Drug: retarded release phosphatidylcholine
    2g daily, given orally QTD

Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00259571

Medical Hospital - University of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Dietmar Hopp Stiftung
Principal Investigator: Wolfgang Stremmel, Professor Heidelberg University
  More Information

Publications: Identifier: NCT00259571     History of Changes
Other Study ID Numbers: PC4
EC - L389/2003
BFARM - 402 2918
Study First Received: November 28, 2005
Last Updated: December 12, 2013

Keywords provided by Heidelberg University:
non-inferiority study

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases processed this record on September 21, 2017