Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis

This study is ongoing, but not recruiting participants.

First Received: September 14, 2005 Last Updated: March 10, 2008 History of Changes

Sponsor:	Mayo Clinic
Collaborator:	AstraZeneca
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00217022

Purpose

Patients receive budesonide or placebo for the treatment of active lymphocytic colitis. This study includes stool collections, blood draws, weekly questionnaires and a sigmoidoscopy.

Condition	Intervention	Phase
Lymphocytic Colitis Diarrhea	Drug: Budesonide	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo Controlled Trial of Budesonide for the Treatment of Active Lymphocytic Colitis

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Satisfactory control of diarrhea during at least three of the last four weeks

Secondary Outcome Measures:

Histologic improvement in post treatment colon biopsies compared to baseline biopsies
Side effects and time (in days) to recurrence of diarrhea after discontinuation of study drug

Estimated Enrollment:	30
Study Start Date:	June 2003
Estimated Study Completion Date:	April 2008

Detailed Description:

Patients have stool specimen and blood drawn at the start of the study. Patient takes ether Budesonide or placebo for 8 weeks. At the end of treatment, patient has stool collection and sigmoidoscopy.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diarrhea, defined as greater than 4 bowel movements per day and greater than "mild"; currently on no treatment or active despite treatment.
Lymphocytic colitis confirmed histologically within one year of enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00217022

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

AstraZeneca

Investigators

Principal Investigator:

Darrell S. Pardi, M.D.

Mayo Clinic

More Information

No publications provided

Study ID Numbers:	1132-03, IRUSBUEN0002
Study First Received:	September 14, 2005
Last Updated:	March 10, 2008
ClinicalTrials.gov Identifier:	NCT00217022 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mayo Clinic:

Positive colon biopsy for Lymphocytic Colitis within last year

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Colitis, Microscopic
Diarrhea
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Physiological Effects of Drugs
Colonic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Intestinal Diseases

Hormones
Glucocorticoids
Colitis, Lymphocytic
Pharmacologic Actions
Signs and Symptoms
Digestive System Diseases
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Gastroenteritis
Colitis
Bronchodilator Agents

ClinicalTrials.gov processed this record on November 27, 2009