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Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00259571
Recruitment Status : Withdrawn (Missing financial sponsorship)
First Posted : November 29, 2005
Last Update Posted : December 13, 2013
Dietmar Hopp Stiftung
Information provided by:
Heidelberg University

Brief 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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: retarded release phosphatidylcholine Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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.
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Lecithin

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

Primary Outcome Measures :
  1. rate of relapses
  2. 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 :
  1. time to the first relapse
  2. amount of relapses per year
  3. endoscopic index
  4. histolgical score
  5. life quality
  6. side effects

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00259571

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

Layout table for additonal information Identifier: NCT00259571    
Other Study ID Numbers: PC4
EC - L389/2003
BFARM - 402 2918
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: December 13, 2013
Last Verified: November 2005
Keywords provided by Heidelberg University:
non-inferiority study
Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases