Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis - Full Text View

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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Enrollment:	30
Study Start Date:	June 2003
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

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

ClinicalTrials.gov Identifier:	NCT00217022 History of Changes
Other Study ID Numbers:	1132-03, IRUSBUEN0002
Study First Received:	September 14, 2005
Last Updated:	January 19, 2010
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:

Colitis
Diarrhea
Colitis, Lymphocytic
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Colitis, Microscopic
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 February 12, 2012