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NCT Number: NCT00259545

Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis

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.

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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 Phosphatidylcholine

Age range

16 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Heidelberg - Medical Department 4 - Gastroenterology

Heidelberg, 69120, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Retarded Release Phosphatidylcholine (rPC)

Drug

Primary outcomes

  1. complete steroid reduction

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Collaborators

  • Dietmar Hopp Stiftung
  • Professor Wolfgang Stremmel

Registry information

Official study title

Prospektive, Randomisierte Doppelblinde Studie Zur Wirksamkeit Von Intestinal Retardiert Freigesetztem Phosphatidylcholine Bei therapierefraktärer Colitis Ulcerosa Mit Chronisch Aktivem Verlauf Unter Corticosteroiden

Important dates

Study start
2003
Study completion
2006
First posted
Nov 29, 2005
Registry last updated
Jun 5, 2008

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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