Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis

Phase 2

Completed

• Conditions: Ulcerative Colitis

• Registration Number: NCT00259558
• Lead Sponsor: Heidelberg University

Brief Summary

The purpose of this study is to find the optimal dose of retarded release Phosphatidylcholine in the most severe form of ulcerative colitis.

The hypothesis is that ulcerative colitis (UC) is caused by a barrier dysfunction of the colonic mucus layer. The background of the study is the finding, that the phosphatidylcholine (PC) content of the colonic mucus is strongly reduced in UC compared to healthy controls and patients with Crohn´s disease. The content was meuasured in non-inflamed areas of the colon in UC. Thus, we evaluate whether a substitution of colonic PC is an effective method.

Detailed Description

Design: prospective, randomized, double-blind, dose-finding study with retarded phosphatidylcholine.

Population: 10 patients per dose group (6 doses) - 60 patients Remark: this includes to historic groups from another study Inclusion criteria: Ulcerative Pancolitis with chronic active course and a clinical index (Rachmilewitz) over 7 and more, endoscopic index of at least 7 or more. No systemic steroids or immunosuppressants since 4 weeks.

Exclusion criteria: Pregnancy \& fulminant course

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-11-25
• Study First Submitted QC: 2005-11-25
• Study First Posted: 2005-11-29
• Study Completion: 2006-03
• Status Verified: 2007-02
• Last Update Submitted: 2007-02-07
• Last Update Posted: 2007-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• chronic active ulcerative pancolitis
• course more than 4 months
• clinical index rachmilewitz 7 or more
• endoskopic index 7 or more

Exclusion Criteria

• steroids in the last 4 weeks
• immunosuppressants in the last 4 weeks
• use of topical klymsa
• pregnancy
• fulminant course
• infectious colitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Absolute change in clinical activity index (Rachmilewitz).

Secondary Outcome Measures

Name	Time	Method
Secondary end points include >50% changes in clinical and endoscopic activity index (EAI).
Histology and life quality are reported descriptively.

Trial Locations

Locations (1)

Medical Hospital Unversity Heidelberg; 🇩🇪 Heidelberg, Germany