Status:
COMPLETED
Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis
Lead Sponsor:
Heidelberg University
Collaborating Sponsors:
Prof. Wolfgang Stremmel
Dietmar Hopp Stiftung
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
16-90 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to find the optimal dose of retarded release Phosphatidylcholine in the most severe form of ulcerative colitis. The hypothesis is that ulcerative colitis (UC) is caused b...
Detailed Description
Design: prospective, randomized, double-blind, dose-finding study with retarded phosphatidylcholine. Population: 10 patients per dose group (6 doses) - 60 patients Remark: this includes to historic g...
Eligibility Criteria
Inclusion
- chronic active ulcerative pancolitis
- course more than 4 months
- clinical index rachmilewitz 7 or more
- endoskopic index 7 or more
Exclusion
- steroids in the last 4 weeks
- immunosuppressants in the last 4 weeks
- use of topical klymsa
- pregnancy
- fulminant course
- infectious colitis
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00259558
Start Date
April 1 2003
End Date
March 1 2006
Last Update
February 12 2007
Active Locations (1)
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1
Medical Hospital Unversity Heidelberg
Heidelberg, Germany, 69120