Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis - Full Text View

Sponsors and Collaborators:	University of Heidelberg Prof. Wolfgang Stremmel Dietmar Hopp Stiftung
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00259558

Purpose

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.

Condition	Intervention	Phase
Ulcerative Colitis	Drug: retarded release phosphatidylcholine	Phase II

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Lecithin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prospektive, Randomisierte Doppelblinde Studie Zur Dosisfindung Von Intestinal Redardiert Freigesetztem Phosphatidylcholin Bei Chronisch Aktiver Pancolitis Ulcerosa

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

Absolute change in clinical activity index (Rachmilewitz).

Secondary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	April 2003
Estimated Study Completion Date:	March 2006

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

Eligibility

Ages Eligible for Study:	16 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259558

Locations

Germany
Medical Hospital Unversity Heidelberg
Heidelberg, Germany, 69120

Sponsors and Collaborators

University of Heidelberg

Prof. Wolfgang Stremmel

Dietmar Hopp Stiftung

Investigators

Principal Investigator:

Wolfgang Stremmel, Professor

University Heidelberg

More Information

Publications:

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.

Study ID Numbers:	PC3, EC - L069/2003, BFARM - 402 2919
Study First Received:	November 25, 2005
Last Updated:	February 7, 2007
ClinicalTrials.gov Identifier:	NCT00259558
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:

Ulcerative Colitis
Dose Finding
Phosphatidylcholine

Study placed in the following topic categories:

Signs and Symptoms
Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases

Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009