Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.

This study is not yet open for participant recruitment.

Verified by University of Heidelberg, November 2005

Sponsors and Collaborators:	University of Heidelberg Prof. W. Stremmel Dietmar Hopp Stiftung
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00259571

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 II Phase III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Lecithin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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.

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:	December 2009

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

Contacts

Contact: Wolfgang Stremmel, Professor	+49-6221-56-38717	wolfgang.stremmel@med.uni-heidelberg.de
Contact: Max Karner, MD	+49-6221-56-38708	max.karner@med.uni-heidelberg.de

Locations

Germany
Medical Hospital - University of Heidelberg
Heidelberg, Germany, 69120

Sponsors and Collaborators

University of Heidelberg

Prof. W. Stremmel

Dietmar Hopp Stiftung

Investigators

Principal Investigator:

Wolfgang Stremmel, Professor

University of Heidelberg

More Information

Publications:

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.

Study ID Numbers:	PC4, EC - L389/2003, BFARM - 402 2918
Study First Received:	November 28, 2005
Last Updated:	May 30, 2006
ClinicalTrials.gov Identifier:	NCT00259571
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:

remission
mesalazin
non-inferiority study
relapse

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases

Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009