Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis

This study has been completed.
Sponsor:
Collaborators:
Professor Wolfgang Stremmel
Dietmar Hopp Stiftung
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00259545
First received: November 25, 2005
Last updated: June 4, 2008
Last verified: June 2008
  Purpose

The purpose of this study is to evaluate if retarded release phosphatidylcholine is an effective alternative to steroid dependent or -refractory course in chronic active ulcerative colitis.

The hypothesis is, that ulcerative colitis is caused by a barrier defect of the colonic mucus layer. The background of the study is the finding, that the phosophatidylcholine content of the colonic mucus is strongly reduced in ulcerative colitis (UC) compared to healthy controls and patients with Crohn´s disease. The content was measured in non-inflamed areas of the colon in UC. Thus, we evaluate whether a substitution of colonic PC is an effective method for steroid dependent UC. See: Gut. 2005 Jul;54(7):966-71. Stremmel et al.


Condition Intervention Phase
Ulcerative Colitis
Phosphatidylcholine
Drug: Retarded Release Phosphatidylcholine (rPC)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Prospektive, Randomisierte Doppelblinde Studie Zur Wirksamkeit Von Intestinal Retardiert Freigesetztem Phosphatidylcholine Bei therapierefraktärer Colitis Ulcerosa Mit Chronisch Aktivem Verlauf Unter Corticosteroiden

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • complete steroid reduction

Secondary Outcome Measures:
  • remission, life quality, clinical indices, endoscopic indices, histological score, subgroup analysis

Estimated Enrollment: 60
Study Start Date: February 2003
Estimated Study Completion Date: February 2006
Detailed Description:

Design: Prospective, randomized, placebo-controlled, double-blinded study.

Population: 60 patients with chronic active ulcerative colitis and steroid dependency

Inclusion: Chronic active ulcerative colitis, clinical index 5 or more, endoscopic Index 5 or more, steroid dependent course since at least 4 months.

Main criteria: complete steroid reduction

  Eligibility

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

Inclusion Criteria:

  • Signed Letter of Content
  • diagnosis of ulcerative colitis (clinical, endoscopic and histologic evidence)
  • chronic active and steroid dependent course over at least 4 months (CAI > 4, EAI > 4)

Exclusion Criteria:

  • infectious colitis
  • toxic megacolon
  • ulcerative proctitis or less than 20cm inflamed
  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: NCT00259545

Locations
Germany
University Heidelberg - Medical Department 4 - Gastroenterology
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Professor Wolfgang Stremmel
Dietmar Hopp Stiftung
Investigators
Principal Investigator: Wolfgang Stremmel, Professor Heidelberg University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00259545     History of Changes
Other Study ID Numbers: PC2, EC - L71/2003, BFARM - 402 29 17
Study First Received: November 25, 2005
Last Updated: June 4, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heidelberg University:
retarded phosphatidylcholine
chronic active
steroid

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014