- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00259545
Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis
Prospektive, Randomisierte Doppelblinde Studie Zur Wirksamkeit Von Intestinal Retardiert Freigesetztem Phosphatidylcholine Bei therapierefraktärer Colitis Ulcerosa Mit Chronisch Aktivem Verlauf Unter Corticosteroiden
The purpose of this study is to evaluate if retarded release phosphatidylcholine is an effective alternative to steroid dependent or -refractory course in chronic active ulcerative colitis.
The hypothesis is, that ulcerative colitis is caused by a barrier defect of the colonic mucus layer. The background of the study is the finding, that the phosophatidylcholine content of the colonic mucus is strongly reduced in ulcerative colitis (UC) compared to healthy controls and patients with Crohn´s disease. The content was measured in non-inflamed areas of the colon in UC. Thus, we evaluate whether a substitution of colonic PC is an effective method for steroid dependent UC. See: Gut. 2005 Jul;54(7):966-71. Stremmel et al.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Design: Prospective, randomized, placebo-controlled, double-blinded study.
Population: 60 patients with chronic active ulcerative colitis and steroid dependency
Inclusion: Chronic active ulcerative colitis, clinical index 5 or more, endoscopic Index 5 or more, steroid dependent course since at least 4 months.
Main criteria: complete steroid reduction
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Heidelberg, Germany, 69120
- University Heidelberg - Medical Department 4 - Gastroenterology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed Letter of Content
- diagnosis of ulcerative colitis (clinical, endoscopic and histologic evidence)
- chronic active and steroid dependent course over at least 4 months (CAI > 4, EAI > 4)
Exclusion Criteria:
- infectious colitis
- toxic megacolon
- ulcerative proctitis or less than 20cm inflamed
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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complete steroid reduction
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Secondary Outcome Measures
Outcome Measure |
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remission, life quality, clinical indices, endoscopic indices, histological score, subgroup analysis
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wolfgang Stremmel, Professor, Heidelberg University
Publications and helpful links
General 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. doi: 10.1136/gut.2004.052316.
- Stremmel W, Ehehalt R, Autschbach F, Karner M. Phosphatidylcholine for steroid-refractory chronic ulcerative colitis: a randomized trial. Ann Intern Med. 2007 Nov 6;147(9):603-10. doi: 10.7326/0003-4819-147-9-200711060-00004.
Study record dates
Study Major Dates
Study Start
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- PC2
- EC - L71/2003
- BFARM - 402 29 17
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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Clinical Trials on Retarded Release Phosphatidylcholine (rPC)
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Heidelberg UniversityCompletedUlcerative ColitisGermany
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Heidelberg UniversityDietmar Hopp StiftungWithdrawnUlcerative ColitisGermany