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Completed

NCT Number: NCT00180050

Budesonide Treatment for Lymphocytic Colitis

The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis

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Key information

Conditions

Microscopic Colitis Colitis Colitis, Lymphocytic 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 the treatment of lymphocytic colitis

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • lymphocytic colitis
  • diarrhea
  • effective contraception
  • written informed consent

Exclusion criteria

  • other forms if IBD
  • celiac disease
  • infectious colitis
  • history of colonic surgery
  • use of budesonide, 5-ASA, steroids within th previous 4 weeks
  • pregnancy, lactation

Treatment and study plan

Budesonide

Drug

Primary outcomes

  1. Proportion of patients in clinical remission after 6 weeks

Secondary outcomes

  1. safety

  2. quality of life

  3. histological improvement

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • Dr. Falk Pharma GmbH

Registry information

Official study title

Efficacy and Safety of Budesonide for Treatment of Lymphocytic Colitis

Important dates

Study start
2002
Primary completion
2006
Study completion
2007
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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