Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis

This study has been completed.

Sponsor:

Collaborators:

Prof. Wolfgang Stremmel

Dietmar Hopp Stiftung

Information provided by:

Heidelberg University

ClinicalTrials.gov Identifier:

NCT00259558

First received: November 25, 2005

Last updated: February 7, 2007

Last verified: February 2007

History of Changes

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 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Prospektive, Randomisierte Doppelblinde Studie Zur Dosisfindung Von Intestinal Redardiert Freigesetztem Phosphatidylcholin Bei Chronisch Aktiver Pancolitis Ulcerosa

Resource links provided by NLM:

Genetics Home Reference related topics: ulcerative colitis

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Lecithin

U.S. FDA Resources

Further study details as provided by Heidelberg University:

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


Germany
Medical Hospital Unversity Heidelberg
Heidelberg, Germany, 69120

Sponsors and Collaborators

Heidelberg University

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Stremmel W, Braun A, Hanemann A, Ehehalt R, Autschbach F, Karner M. Delayed release phosphatidylcholine in chronic-active ulcerative colitis: a randomized, double-blinded, dose finding study. J Clin Gastroenterol. 2010 May-Jun;44(5):e101-7. doi: 10.1097/MCG.0b013e3181c29860.


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

Keywords provided by Heidelberg University:


Ulcerative Colitis Dose Finding Phosphatidylcholine

Additional relevant MeSH terms:


Colitis, Ulcerative Colitis Colonic Diseases Digestive System Diseases	Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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