- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00259571
Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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-
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Heidelberg, Germany, 69120
- Medical Hospital - University of Heidelberg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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rate of relapses
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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
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Secondary Outcome Measures
Outcome Measure |
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time to the first relapse
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amount of relapses per year
|
endoscopic index
|
histolgical score
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life quality
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side effects
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Wolfgang Stremmel, Professor, Heidelberg University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PC4
- EC - L389/2003
- BFARM - 402 2918
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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