Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis - Tabular View

Tracking Information

First Received Date ^ICMJE

November 25, 2005

Last Updated Date

June 4, 2008

Start Date ^ICMJE

February 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

complete steroid reduction

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00259545 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis

Official Title ^ICMJE

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

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.

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Ulcerative Colitis
Phosphatidylcholine

Intervention ^ICMJE

Drug: Retarded Release Phosphatidylcholine (rPC)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

16 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00259545

Responsible Party

Study ID Numbers ^ICMJE

PC2, EC - L71/2003, BFARM - 402 29 17

Study Sponsor ^ICMJE

University of Heidelberg

Collaborators ^ICMJE

Professor Wolfgang Stremmel
Dietmar Hopp Stiftung

Investigators ^ICMJE

Principal Investigator:

Wolfgang Stremmel, Professor

University of Heidelberg

Information Provided By

University of Heidelberg

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP