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Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis

Primary Purpose

Ulcerative Colitis

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

retarded release phosphatidylcholine

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, Dose Finding, Phosphatidylcholine

Eligibility Criteria

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

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

Sites / Locations

Medical Hospital Unversity Heidelberg

Outcomes

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.

Full Information

NCT ID

NCT00259558

First Posted

November 25, 2005

Last Updated

February 7, 2007

Sponsor

Heidelberg University

Collaborators

Prof. Wolfgang Stremmel, Dietmar Hopp Stiftung

1. Study Identification

Unique Protocol Identification Number

NCT00259558

Brief Title

Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis

Official Title

Prospektive, Randomisierte Doppelblinde Studie Zur Dosisfindung Von Intestinal Redardiert Freigesetztem Phosphatidylcholin Bei Chronisch Aktiver Pancolitis Ulcerosa

Study Type

Interventional

2. Study Status

Record Verification Date

February 2007

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Heidelberg University

Collaborators

Prof. Wolfgang Stremmel, Dietmar Hopp Stiftung

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

Keywords

Ulcerative Colitis, Dose Finding, Phosphatidylcholine

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

Primary Outcome Measure Information:

Title

Absolute change in clinical activity index (Rachmilewitz).

Secondary Outcome Measure Information:

Title

Secondary end points include >50% changes in clinical and endoscopic activity index (EAI).

Title

Histology and life quality are reported descriptively.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wolfgang Stremmel, Professor

Organizational Affiliation

University Heidelberg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical Hospital Unversity 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

PubMed Identifier

20048683

Citation

Stremmel W, Braun A, Hanemann A, Ehehalt R, Autschbach F, Karner M. Delayed release phosphatidylcholine in chronic-active ulcerative colitis: a randomized, double-blinded, dose finding study. J Clin Gastroenterol. 2010 May-Jun;44(5):e101-7. doi: 10.1097/MCG.0b013e3181c29860.

Results Reference

derived

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Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis

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