Status:
COMPLETED
Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis
Lead Sponsor:
Heidelberg University
Collaborating Sponsors:
Professor Wolfgang Stremmel
Dietmar Hopp Stiftung
Conditions:
Ulcerative Colitis
Phosphatidylcholine
Eligibility:
All Genders
16-90 years
Phase:
PHASE2
Brief Summary
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 hypot...
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 ...
Eligibility Criteria
Inclusion
- 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
- infectious colitis
- toxic megacolon
- ulcerative proctitis or less than 20cm inflamed
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00259545
Start Date
February 1 2003
End Date
February 1 2006
Last Update
June 5 2008
Active Locations (1)
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1
University Heidelberg - Medical Department 4 - Gastroenterology
Heidelberg, Germany, 69120