Prospektive, Randomisierte Doppelblinde Studie Zur Dosisfindung Von Intestinal Redardiert Freigesetztem Phosphatidylcholin Bei Chronisch Aktiver Pancolitis Ulcerosa

Heidelberg University1 site in 1 country60 target enrollmentApril 2003

ConditionsUlcerative Colitis

Drugsretarded release phosphatidylcholine

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Ulcerative Colitis
Sponsor: Heidelberg University
Enrollment: 60
Locations: 1
Primary Endpoint: Absolute change in clinical activity index (Rachmilewitz).
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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 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

Registry

clinicaltrials.gov

Start Date

April 2003

End Date

March 2006

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel