Not Signed In -
Ulcerative Colitis |
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Clinical Trial: Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.
This study is not yet open for patient recruitment.
Verified by University of Heidelberg November 2005
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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 |
MedlinePlus related topics: Ulcerative Colitis
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.
Secondary Outcomes: - time to the first relapse; - amount of relapses per year; - endoscopic index; - histolgical score; - life quality; - side effects
Expected Total Enrollment: 200
Study start: January 2006; Expected completion: March 2010
Last follow-up: December 2009; Data entry closure: January 2010
Eligibility
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
Location and Contact Information
Max Karner, MD +49-6221-56-38708 max.karner@med.uni-heidelberg.de
Germany
Medical Hospital - University of Heidelberg, Heidelberg, 69120, Germany
Wolfgang Stremmel, Professor, Principal Investigator
Max Karner, MD, Sub-Investigator
Wolfgang Stremmel, Professor, Principal Investigator, 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.
Last Updated: December 8, 2005
Record first received: November 28, 2005
ClinicalTrials.gov Identifier: NCT00259571
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2006-01-10
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