Trial of Mesalamine for the Treatment of Active Microscopic Colitis
Primary Purpose
Microscopic Colitis, Diarrhea
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mesalamine
Sponsored by
About this trial
This is an interventional treatment trial for Microscopic Colitis
Eligibility Criteria
Inclusion Criteria:
- Subjects must be 18 years old and older.
- Have diarrhea and microscopic colitis.
- They need to have a colon biopsy done at the Mayo Clinic in Rochester, MN within a year of enrollment.
Exclusion Criteria:
- None.
Sites / Locations
- Mayo Clinic
Outcomes
Primary Outcome Measures
To determine the efficacy of mesalamine at 1.2g and 4.8g doses in microscopic colitis for providing relief of diarrhea
Secondary Outcome Measures
To compare the safety and tolerability of mesalamine at 1.2g and 4.8g doses in patients with microscopic colitis.
Full Information
NCT ID
NCT00952952
First Posted
August 4, 2009
Last Updated
May 20, 2011
Sponsor
Mayo Clinic
Collaborators
Paul E. Evans MD, William J. Sandborn MD, Edward V. Loftus MD, Thomas C. Smryk MD, Willaim Tremaine MD
1. Study Identification
Unique Protocol Identification Number
NCT00952952
Brief Title
Trial of Mesalamine for the Treatment of Active Microscopic Colitis
Official Title
A Randomized, Dose Ranging Trial of Mesalmine for the Treatment of Active Microscopic Colitis.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
Collaborators
Paul E. Evans MD, William J. Sandborn MD, Edward V. Loftus MD, Thomas C. Smryk MD, Willaim Tremaine MD
4. Oversight
5. Study Description
Brief Summary
Subjects must be 18 years old and older, have diarrhea and microscopic colitis. Pregnant or nursing females are excluded. They can't have other untreated diarrheal conditions. Subjects will receive medication for 8 weeks, followed by sigmoidoscopy with biopsies. The subjects will be monitored weekly. A pathologist will review pre and post treatment biopsies. Subjects that show improvement will be followed for 4 weeks post medication.
Detailed Description
We propose a prospective, randomized trial of mesalamine at 1.2g and 4.8g doses for the treatment of microscopic colitis. Our hypothesis is mesalamine is safe and effective for the treatment of diarrhea in microscopic colitis and that the 4.8g dose is more effective than the 1.2g dose.
We will recruit 70 subjects. The subjects will be randomized into to two groups, 4.8g dose, and 1.2g dose groups. Subjects will receive medication for 8 weeks, followed by sigmoidoscopy with biopsies. The subjects will be monitored weekly. A pathologist will review pre and post treatment biopsies. Responders will be followed for 4 weeks post medication.
Subjects must be 18 years old and older, have diarrhea and microscopic colitis. Subjects will be excluded if they have unsuccessful treatment or side effects to 5-ASA drugs, oral corticosteroids, or salicylate. and antibiotics, mesalamine, bismuth or steroid use in the last two weeks. Subjects may not be on anticholinergics, cholestyramine, digoxin. Pregnant or nursing females are excluded. They can't have other untreated diarrheal conditions.
A two-sample z-score test for proportions will be used to test whether relief rates are different between groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microscopic Colitis, Diarrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Mesalamine
Primary Outcome Measure Information:
Title
To determine the efficacy of mesalamine at 1.2g and 4.8g doses in microscopic colitis for providing relief of diarrhea
Secondary Outcome Measure Information:
Title
To compare the safety and tolerability of mesalamine at 1.2g and 4.8g doses in patients with microscopic colitis.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must be 18 years old and older.
Have diarrhea and microscopic colitis.
They need to have a colon biopsy done at the Mayo Clinic in Rochester, MN within a year of enrollment.
Exclusion Criteria:
None.
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trial of Mesalamine for the Treatment of Active Microscopic Colitis
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