Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis
Prospektive, Randomisierte Doppelblinde Studie Zur Dosisfindung Von Intestinal Redardiert Freigesetztem Phosphatidylcholin Bei Chronisch Aktiver Pancolitis Ulcerosa
3 other identifiers
interventional
60
1 country
1
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 by a barrier dysfunction of the colonic mucus layer. The background of the study is the finding, that the phosphatidylcholine (PC) content of the colonic mucus is strongly reduced in UC compared to healthy controls and patients with Crohn´s disease. The content was meuasured in non-inflamed areas of the colon in UC. Thus, we evaluate whether a substitution of colonic PC is an effective method.
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 Apr 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
April 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
March 1, 2006
CompletedFebruary 12, 2007
February 1, 2007
November 25, 2005
February 7, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absolute change in clinical activity index (Rachmilewitz).
Secondary Outcomes (2)
Secondary end points include >50% changes in clinical and endoscopic activity index (EAI).
Histology and life quality are reported descriptively.
Interventions
Eligibility Criteria
You may qualify if:
- chronic active ulcerative pancolitis
- course more than 4 months
- clinical index rachmilewitz 7 or more
- endoskopic index 7 or more
You may not qualify if:
- steroids in the last 4 weeks
- immunosuppressants in the last 4 weeks
- use of topical klymsa
- pregnancy
- fulminant course
- infectious colitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Heidelberg Universitylead
- Prof. Wolfgang Stremmelcollaborator
- Dietmar Hopp Stiftungcollaborator
Study Sites (1)
Medical Hospital Unversity Heidelberg
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, Braun A, Hanemann A, Ehehalt R, Autschbach F, Karner M. Delayed release phosphatidylcholine in chronic-active ulcerative colitis: a randomized, double-blinded, dose finding study. J Clin Gastroenterol. 2010 May-Jun;44(5):e101-7. doi: 10.1097/MCG.0b013e3181c29860.
PMID: 20048683DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wolfgang Stremmel, Professor
University Heidelberg
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
April 1, 2003
Study Completion
March 1, 2006
Last Updated
February 12, 2007
Record last verified: 2007-02