Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00259558|
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : February 12, 2007
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 or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: retarded release phosphatidylcholine||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prospektive, Randomisierte Doppelblinde Studie Zur Dosisfindung Von Intestinal Redardiert Freigesetztem Phosphatidylcholin Bei Chronisch Aktiver Pancolitis Ulcerosa|
|Study Start Date :||April 2003|
|Study Completion Date :||March 2006|
- Absolute change in clinical activity index (Rachmilewitz).
- Secondary end points include >50% changes in clinical and endoscopic activity index (EAI).
- Histology and life quality are reported descriptively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259558
|Medical Hospital Unversity Heidelberg|
|Heidelberg, Germany, 69120|
|Principal Investigator:||Wolfgang Stremmel, Professor||University Heidelberg|