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Budesonide Treatment for Lymphocytic Colitis

This study has been completed.
Sponsor:
Collaborator:
Dr. Falk Pharma GmbH
Information provided by:
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT00180050
First received: September 9, 2005
Last updated: March 29, 2010
Last verified: March 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Microscopic Colitis
 Drug: Budesonide
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Budesonide for Treatment of Lymphocytic Colitis

Resource links provided by NLM:

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

Further study details as provided by Dresden University of Technology:

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

Secondary Outcome Measures:
  • safety
  • quality of life
  • histological improvement

Estimated Enrollment: 40
Study Start Date: January 2002
Study Completion Date: August 2007
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00180050

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

No publications provided

ClinicalTrials.gov Identifier: NCT00180050     History of Changes
Other Study ID Numbers: BLYCK
Study First Received: September 9, 2005
Last Updated: March 29, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:
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
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013