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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
Sponsor:
Collaborators:
Prof. Wolfgang Stremmel
Dietmar Hopp Stiftung
Information provided by:
Heidelberg University

Tracking Information
First Submitted Date  ICMJE November 25, 2005
First Posted Date  ICMJE November 29, 2005
Last Update Posted Date February 12, 2007
Study Start Date  ICMJE April 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2007)
Absolute change in clinical activity index (Rachmilewitz).
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2005)
Change in clinical index (Rachmilewitz) towards clinical remission CAI (3 or less) or CAI improvement by >50%.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2007)
  • Secondary end points include >50% changes in clinical and endoscopic activity index (EAI).
  • Histology and life quality are reported descriptively.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2005)
Secondary end points include >50% changes in endoscopic activity index (EAI), histology, and quality of life scores.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis
Official Title  ICMJE Prospektive, Randomisierte Doppelblinde Studie Zur Dosisfindung Von Intestinal Redardiert Freigesetztem Phosphatidylcholin Bei Chronisch Aktiver Pancolitis Ulcerosa
Brief Summary

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.

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE Drug: retarded release phosphatidylcholine
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: November 25, 2005)
60
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE March 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00259558
Other Study ID Numbers  ICMJE PC3
EC - L069/2003
BFARM - 402 2919
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Heidelberg University
Collaborators  ICMJE
  • Prof. Wolfgang Stremmel
  • Dietmar Hopp Stiftung
Investigators  ICMJE
Principal Investigator: Wolfgang Stremmel, Professor University Heidelberg
PRS Account Heidelberg University
Verification Date February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP