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
3 other identifiers
interventional
60
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2003
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 25, 2005
CompletedFirst Posted
Study publicly available on registry
November 29, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedJune 5, 2008
June 1, 2008
November 25, 2005
June 4, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
complete steroid reduction
Secondary Outcomes (1)
remission, life quality, clinical indices, endoscopic indices, histological score, subgroup analysis
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- infectious colitis
- toxic megacolon
- ulcerative proctitis or less than 20cm inflamed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Heidelberg Universitylead
- Professor Wolfgang Stremmelcollaborator
- Dietmar Hopp Stiftungcollaborator
Study Sites (1)
University Heidelberg - Medical Department 4 - Gastroenterology
Heidelberg, 69120, Germany
Related Publications (2)
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.
PMID: 15951544BACKGROUNDStremmel 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.
PMID: 17975182DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wolfgang Stremmel, Professor
Heidelberg University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 25, 2005
First Posted
November 29, 2005
Study Start
February 1, 2003
Study Completion
February 1, 2006
Last Updated
June 5, 2008
Record last verified: 2008-06