Trial | NCT00259545  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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.
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 Started
Feb 28
2003
Study Completion
Feb 28
2006
Last Update
Jun 05
2008
Estimate

Drug Retarded Release Phosphatidylcholine (rPC)

Criteria 

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)

Exclusion Criteria:

infectious colitis
toxic megacolon
ulcerative proctitis or less than 20cm inflamed
No Results Posted