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
  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:


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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 19, 2014