Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis - Tabular View

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

March 10, 2008

Start Date ^ICMJE

June 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00217022 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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.

Descriptive Information

Brief Title ^ICMJE

Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis

Official Title ^ICMJE

A Randomized, Double-Blind, Placebo Controlled Trial of Budesonide for the Treatment of Active Lymphocytic Colitis

Brief Summary

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

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.

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Lymphocytic Colitis
Diarrhea

Intervention ^ICMJE

Drug: Budesonide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00217022

Responsible Party

Study ID Numbers ^ICMJE

1132-03, IRUSBUEN0002

Study Sponsor ^ICMJE

Mayo Clinic

Collaborators ^ICMJE

AstraZeneca

Investigators ^ICMJE

Principal Investigator:

Darrell S. Pardi, M.D.

Mayo Clinic

Information Provided By

Mayo Clinic

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP