Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis

Sponsor

Heidelberg University (Other)

Overall Status

Completed

CT.gov ID

NCT00259545

Collaborator

Professor Wolfgang Stremmel (Other), Dietmar Hopp Stiftung (Other)

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis Phosphatidylcholine	Drug: Retarded Release Phosphatidylcholine (rPC)	Phase 2

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

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Prospektive, Randomisierte Doppelblinde Studie Zur Wirksamkeit Von Intestinal Retardiert Freigesetztem Phosphatidylcholine Bei therapierefraktärer Colitis Ulcerosa Mit Chronisch Aktivem Verlauf Unter Corticosteroiden

Study Start Date :

Feb 1, 2003

Study Completion Date :

Feb 1, 2006

Outcome Measures

Primary Outcome Measures

complete steroid reduction []

Secondary Outcome Measures

remission, life quality, clinical indices, endoscopic indices, histological score, subgroup analysis []

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Signed Letter of Content
diagnosis of ulcerative colitis (clinical, endoscopic and histologic evidence)
chronic active and steroid dependent course over at least 4 months (CAI > 4, EAI > 4)