Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Prospektive, Randomisierte Doppelblinde Studie Zur Dosisfindung Von Intestinal Redardiert Freigesetztem Phosphatidylcholin Bei Chronisch Aktiver Pancolitis Ulcerosa|
- Absolute change in clinical activity index (Rachmilewitz).
- Secondary end points include >50% changes in clinical and endoscopic activity index (EAI).
- Histology and life quality are reported descriptively.
|Study Start Date:||April 2003|
|Estimated Study Completion Date:||March 2006|
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 groups from another study Inclusion criteria: Ulcerative Pancolitis with chronic active course and a clinical index (Rachmilewitz) over 7 and more, endoscopic index of at least 7 or more. No systemic steroids or immunosuppressants since 4 weeks.
Exclusion criteria: Pregnancy & fulminant course
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259558
|Medical Hospital Unversity Heidelberg|
|Heidelberg, Germany, 69120|
|Principal Investigator:||Wolfgang Stremmel, Professor||University Heidelberg|