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Budesonide Treatment for Lymphocytic Colitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00180050
First Posted: September 16, 2005
Last Update Posted: March 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dr. Falk Pharma GmbH
Information provided by:
Technische Universität Dresden
  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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Budesonide for Treatment of Lymphocytic Colitis

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00180050     History of Changes
Other Study ID Numbers: BLYCK
First Submitted: September 9, 2005
First Posted: September 16, 2005
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