Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis
Information source: Mayo Clinic
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphocytic Colitis; Diarrhea
Intervention: Budesonide (Drug)
Phase: Phase 2/Phase 3
Status: Active, not recruiting
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s):
Darrell S. Pardi, M.D., Principal Investigator, Affiliation: Mayo Clinic
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.
Clinical Details
Official title: A Randomized, Double-Blind, Placebo Controlled Trial of Budesonide for the Treatment of Active Lymphocytic Colitis
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Satisfactory control of diarrhea during at least three of the last four weeks
Secondary outcome: Histologic improvement in post treatment colon biopsies compared to baseline biopsiesSide effects and time (in days) to recurrence of diarrhea after discontinuation of study drug
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Mayo Clinic, Rochester, Minnesota 55905, United States
Additional Information
Starting date: June 2003
Ending date: April 2008
Last updated: March 10, 2008
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