Trial of Mesalamine for the Treatment of Active Microscopic Colitis

Diarrhea Clinical Trial

Official title:

A Randomized, Dose Ranging Trial of Mesalmine for the Treatment of Active Microscopic Colitis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00952952
• Other study ID #: 06-003637
• Secondary ID: evans 06
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 4, 2009
• Last updated: May 20, 2011
• Start date: February 2007
• Est. completion date: November 2007

Study information

• Verified date: May 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Microscopic
• Diarrhea
• Microscopic Colitis

Intervention

Drug:
• Mesalamine

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (6)

Lead Sponsor	Collaborator
Mayo Clinic	Edward V. Loftus MD, Paul E. Evans MD, Thomas C. Smryk MD, Willaim Tremaine MD, William J. Sandborn MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the efficacy of mesalamine at 1.2g and 4.8g doses in microscopic colitis for providing relief of diarrhea
Secondary	To compare the safety and tolerability of mesalamine at 1.2g and 4.8g doses in patients with microscopic colitis.