NCT00259558

Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 16 Years – 90 Years
• Healthy volunteers: Not accepted

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

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	retarded release phosphatidylcholine

Timeline

• Start date: 2003-04-01
• Completion: 2006-03-01
• First posted: 2005-11-29
• Last updated: 2007-02-12

Locations

1 site across 1 country: Germany