Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.
NCT ID: NCT00259571
Last Updated: 2013-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2/PHASE3
INTERVENTIONAL
2010-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
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retarded release phosphatidylcholine
2g daily, given orally QTD
Eligibility Criteria
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Inclusion Criteria
* 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
* steroids or immunosuppressants
* acute episode of UC
* condition after complete or partial colektomy
* known intolerance to mesalazin
* severe medical disease other than colitis
15 Years
80 Years
ALL
No
Sponsors
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Dietmar Hopp Stiftung
OTHER
Heidelberg University
OTHER
Principal Investigators
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Wolfgang Stremmel, Professor
Role: PRINCIPAL_INVESTIGATOR
Heidelberg University
Locations
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Medical Hospital - University of Heidelberg
Heidelberg, , Germany
Countries
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References
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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. doi: 10.1136/gut.2004.052316.
Other Identifiers
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EC - L389/2003
Identifier Type: -
Identifier Source: secondary_id
BFARM - 402 2918
Identifier Type: -
Identifier Source: secondary_id
PC4
Identifier Type: -
Identifier Source: org_study_id