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Budesonide Treatment for Lymphocytic Colitis

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ClinicalTrials.gov Identifier: NCT00180050
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 30, 2010
Sponsor:
Collaborator:
Dr. Falk Pharma GmbH
Information provided by:
Technische Universität Dresden

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

Condition or disease Intervention/treatment Phase
Microscopic Colitis Drug: Budesonide Phase 3

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Budesonide for Treatment of Lymphocytic Colitis
Study Start Date : January 2002
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide
U.S. FDA Resources




Primary Outcome Measures :
  1. Proportion of patients in clinical remission after 6 weeks

Secondary Outcome Measures :
  1. safety
  2. quality of life
  3. histological improvement


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00180050


Locations
Germany
Medical Department I, Technical University Hospital
Dresden, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Dr. Falk Pharma GmbH
Investigators
Principal Investigator: Stephan Miehlke, Prof. Medical Department I, Technical University Hospital, Dresden, Germany

ClinicalTrials.gov Identifier: NCT00180050     History of Changes
Other Study ID Numbers: BLYCK
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: March 30, 2010
Last Verified: March 2010

Keywords provided by Technische Universität Dresden:
lymphocytic colitis
microscopic colitis
budesonide

Additional relevant MeSH terms:
Colitis
Colitis, Microscopic
Colitis, Lymphocytic
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists