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Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.

This study has suspended participant recruitment.
(Missing financial sponsorship)
Sponsor:
Collaborator:
Dietmar Hopp Stiftung
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00259571
First received: November 28, 2005
Last updated: August 15, 2011
Last verified: November 2005
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

Drug Information available for: Lecithin
U.S. FDA Resources

Further study details as provided by University of Heidelberg:

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

Estimated Enrollment: 200
Estimated Study Completion Date: March 2010
Intervention Details:
    Drug: retarded release phosphatidylcholine
    2g daily, given orally QTD
  Eligibility

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259571

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

Publications:

ClinicalTrials.gov Identifier: NCT00259571     History of Changes
Other Study ID Numbers: PC4, EC - L389/2003, BFARM - 402 2918
Study First Received: November 28, 2005
Last Updated: August 15, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:
remission
mesalazin
non-inferiority study
relapse

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013