Trial of Mesalamine for the Treatment of Active Microscopic Colitis

NCT ID: NCT00952952

Last Updated: 2011-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2007-11-30

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.

Conditions

Microscopic Colitis; Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Mesalamine

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Paul E. Evans MD

UNKNOWN

Sponsor Role: collaborator

William J. Sandborn MD

UNKNOWN

Sponsor Role: collaborator

Edward V. Loftus MD

UNKNOWN

Sponsor Role: collaborator

Thomas C. Smryk MD

UNKNOWN

Sponsor Role: collaborator

Willaim Tremaine MD

UNKNOWN

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

evans 06

Identifier Type: -

Identifier Source: secondary_id

06-003637

Identifier Type: -

Identifier Source: org_study_id