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Completed

NCT Number: NCT00259558

Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

16 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical Hospital Unversity Heidelberg

Heidelberg, 69120, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

retarded release phosphatidylcholine

Drug

Primary outcomes

  1. Absolute change in clinical activity index (Rachmilewitz).

Secondary outcomes

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

  2. Histology and life quality are reported descriptively.

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Collaborators

  • Dietmar Hopp Stiftung
  • Prof. Wolfgang Stremmel

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2006
First posted
Nov 29, 2005
Registry last updated
Feb 12, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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