NCT00259545

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

• 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 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.

Detailed description

Design: Prospective, randomized, placebo-controlled, double-blinded study. Population: 60 patients with chronic active ulcerative colitis and steroid dependency Inclusion: Chronic active ulcerative colitis, clinical index 5 or more, endoscopic Index 5 or more, steroid dependent course since at least 4 months. Main criteria: complete steroid reduction

Conditions

• Ulcerative Colitis
• Phosphatidylcholine

Interventions

Type	Name	Description
DRUG	Retarded Release Phosphatidylcholine (rPC)

Timeline

• Start date: 2003-02-01
• Completion: 2006-02-01
• First posted: 2005-11-29
• Last updated: 2008-06-05

Locations

1 site across 1 country: Germany