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Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.

Primary Purpose

Ulcerative Colitis

Status
Withdrawn
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
retarded release phosphatidylcholine
Sponsored by
Heidelberg University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ulcerative Colitis focused on measuring remission, mesalazin, non-inferiority study, relapse

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: diagnosis of ulcerative colitis in remission (CAI 3 or less) signed letter of content no steroids or immunosupressants in the last 6 weeks at least 5 relapses in the last 3 years last relapse was 8 months ago or less complete colonoscopy at entry Exclusion Criteria: pregnancy or breast feeding steroids or immunosuppressants acute episode of UC condition after complete or partial colektomy known intolerance to mesalazin severe medical disease other than colitis

Sites / Locations

  • Medical Hospital - University of Heidelberg

Outcomes

Primary Outcome Measures

rate of relapses
relapse is defined as an increase of the clinical Rachmilewitz index to 5 or more, but at least 3 points over a period of 14 days

Secondary Outcome Measures

time to the first relapse
amount of relapses per year
endoscopic index
histolgical score
life quality
side effects

Full Information

First Posted
November 28, 2005
Last Updated
December 12, 2013
Sponsor
Heidelberg University
Collaborators
Dietmar Hopp Stiftung
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1. Study Identification

Unique Protocol Identification Number
NCT00259571
Brief Title
Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.
Official Title
Prospektive, Randomisierte, Doppelblinde, Mesalazin-kontrollierte ("Double-dummy Verfahren) Multizenter-Studie Zur Beurteilung Der Annahme Der äquivalenten Wirkung Von Intestinal Retardiert Freigesetztem Phosphatidylcholin gegenüber Mesalazin (Non-inferiority Study) in Der Remissionserhaltung Der Colitis Ulcerosa.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Withdrawn
Why Stopped
Missing financial sponsorship
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2010 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Heidelberg University
Collaborators
Dietmar Hopp Stiftung

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate if retarded phosphatidylcholine is as effective as mesalazin in preventing an acute episode in ulcerative colitis. The hypothesis is, that ulcerative colitis is cuased by a defect in the barrier function of the colonic mucus. The background of the study is the finding that the phosphatidylcholine content of the colonic mucus is reduced in patients with ulcerative colitis, in both healthy and inflamed parts of the colon.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
remission, mesalazin, non-inferiority study, relapse

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
retarded release phosphatidylcholine
Intervention Description
2g daily, given orally QTD
Primary Outcome Measure Information:
Title
rate of relapses
Title
relapse is defined as an increase of the clinical Rachmilewitz index to 5 or more, but at least 3 points over a period of 14 days
Secondary Outcome Measure Information:
Title
time to the first relapse
Title
amount of relapses per year
Title
endoscopic index
Title
histolgical score
Title
life quality
Title
side effects

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of ulcerative colitis in remission (CAI 3 or less) signed letter of content no steroids or immunosupressants in the last 6 weeks at least 5 relapses in the last 3 years last relapse was 8 months ago or less complete colonoscopy at entry Exclusion Criteria: pregnancy or breast feeding steroids or immunosuppressants acute episode of UC condition after complete or partial colektomy known intolerance to mesalazin severe medical disease other than colitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Stremmel, Professor
Organizational Affiliation
Heidelberg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Hospital - University of Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
15951544
Citation
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. doi: 10.1136/gut.2004.052316.
Results Reference
background

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Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.

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