Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259545
• Other study ID #: PC2
• Secondary ID: EC - L71/2003BFA
• Status: Completed
• Phase: Phase 2
• First received: November 25, 2005
• Last updated: June 4, 2008
• Start date: February 2003
• Est. completion date: February 2006

Study information

• Verified date: June 2008
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Phosphatidylcholine
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Retarded Release Phosphatidylcholine (rPC)

Locations

Country	Name	City	State
Germany	University Heidelberg - Medical Department 4 - Gastroenterology	Heidelberg

Sponsors (3)

Lead Sponsor	Collaborator
Heidelberg University	Dietmar Hopp Stiftung, Professor Wolfgang Stremmel

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Stremmel W, Merle U, Zahn A, Autschbach F, Hinz U, Ehehalt R. Retarded release phosphatidylcholine benefits patients with chronic active ulcerative colitis. Gut. 2005 Jul;54(7):966-71. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete steroid reduction
Secondary	remission, life quality, clinical indices, endoscopic indices, histological score, subgroup analysis