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Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis

NCT00259558 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2007-02-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

retarded release phosphatidylcholine

Sponsors & Collaborators

  • Prof. Wolfgang Stremmel

    collaborator UNKNOWN

  • Dietmar Hopp Stiftung

    collaborator OTHER

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Wolfgang Stremmel, Professor · University Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Completion
2006-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00259558 on ClinicalTrials.gov