search
Back to results

Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis

Primary Purpose

Ulcerative Colitis, Phosphatidylcholine

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Retarded Release Phosphatidylcholine (rPC)
Sponsored by
Heidelberg University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring retarded phosphatidylcholine, chronic active, steroid

Eligibility Criteria

16 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Heidelberg - Medical Department 4 - Gastroenterology

Outcomes

Primary Outcome Measures

complete steroid reduction

Secondary Outcome Measures

remission, life quality, clinical indices, endoscopic indices, histological score, subgroup analysis

Full Information

First Posted
November 25, 2005
Last Updated
June 4, 2008
Sponsor
Heidelberg University
Collaborators
Professor Wolfgang Stremmel, Dietmar Hopp Stiftung
search

1. Study Identification

Unique Protocol Identification Number
NCT00259545
Brief Title
Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis
Official Title
Prospektive, Randomisierte Doppelblinde Studie Zur Wirksamkeit Von Intestinal Retardiert Freigesetztem Phosphatidylcholine Bei therapierefraktärer Colitis Ulcerosa Mit Chronisch Aktivem Verlauf Unter Corticosteroiden
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Heidelberg University
Collaborators
Professor Wolfgang Stremmel, Dietmar Hopp Stiftung

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Phosphatidylcholine
Keywords
retarded phosphatidylcholine, chronic active, steroid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Retarded Release Phosphatidylcholine (rPC)
Primary Outcome Measure Information:
Title
complete steroid reduction
Secondary Outcome Measure Information:
Title
remission, life quality, clinical indices, endoscopic indices, histological score, subgroup analysis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
University Heidelberg - Medical Department 4 - Gastroenterology
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
PubMed Identifier
17975182
Citation
Stremmel W, Ehehalt R, Autschbach F, Karner M. Phosphatidylcholine for steroid-refractory chronic ulcerative colitis: a randomized trial. Ann Intern Med. 2007 Nov 6;147(9):603-10. doi: 10.7326/0003-4819-147-9-200711060-00004.
Results Reference
derived

Learn more about this trial

Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis

We'll reach out to this number within 24 hrs