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Completed

NCT Number: NCT00180076

Budesonide for Maintenance Treatment of Collagenous Colitis

The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.

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Key information

Conditions

Collagenous Colitis Colitis Colitis, Collagenous Colitis, Microscopic Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical Department I, Technical University Hospital

Dresden, 01307, Germany

About this study

The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • collagenous colitis
  • diarrhea
  • written informed consent

Exclusion criteria

  • infectious causes for diarrhea
  • other inflammatory bowel diseases
  • history of colonic surgery
  • celiac disease
  • malignancies
  • severe concomitant diseases
  • use of budesonide, steroids, mesalazine within the previous 2 weeks
  • known intolerance to budesonide
  • history of lack of response to budesonide
  • pregnancy,lactation
  • drug and/or alcohol abuse
  • lack of compliance

Treatment and study plan

Budesonide

Drug

Primary outcomes

  1. Proportion of patients in clinical remission after 6 months

Secondary outcomes

  1. time to relapse

  2. safety

  3. quality of life

  4. histological improvement

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

Efficacy and Safety of Budesonide in Maintenance Treatment of Collagenous Colitis

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Sep 16, 2005
Registry last updated
Mar 30, 2010

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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