Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis

Ulcerative Colitis Clinical Trial

Official title:

Prospektive, Randomisierte Doppelblinde Studie Zur Dosisfindung Von Intestinal Redardiert Freigesetztem Phosphatidylcholin Bei Chronisch Aktiver Pancolitis Ulcerosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259558
• Other study ID #: PC3
• Secondary ID: EC - L069/2003BF
• Status: Completed
• Phase: Phase 2
• First received: November 25, 2005
• Last updated: February 7, 2007
• Start date: April 2003
• Est. completion date: March 2006

Study information

• Verified date: February 2007
• 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 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.

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

Recruitment information / eligibility

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

Eligibility

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

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

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Ulcerative Colitis

Intervention

Drug:
• retarded release phosphatidylcholine

Locations

Country	Name	City	State
Germany	Medical Hospital Unversity Heidelberg	Heidelberg

Sponsors (3)

Lead Sponsor	Collaborator
Heidelberg University	Dietmar Hopp Stiftung, Prof. 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	Absolute change in clinical activity index (Rachmilewitz).
Secondary	Secondary end points include >50% changes in clinical and endoscopic activity index (EAI).
Secondary	Histology and life quality are reported descriptively.