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Clinical Trial Summary

The objectives of this bioequivalence study in patients with ulcerative colitis (UC) were:

- To establish the therapeutic equivalence of mesalamine delayed release tablet (MDRT) and Asacol Delayed Release Tablets 2.4 g per day (800 mg three times daily) and

- To evaluate the safety of MDRT 2.4 g per day (800 mg three times daily) compared to placebo.


Clinical Trial Description

This was a multi-center, randomized, parallel-groups comparison of two mesalamine products for treatment of ulcerative colitis. Patients were randomly assigned in an optimized 2:2:1 ratio to MDRT 2.4 g/day, Asacol 2.4 g/day, or placebo. The study was partially blinded due to the difficulties associated with creating placebo that matched both MDRT and Asacol; the placebo matched the MDRT formulation. Placebo groups served as control in the parallel group comparison between MDRT and Asacol. Patients were treated for 6 weeks after randomization and followed through Day 56, which was considered of sufficient length to accommodate any safety issues and to assess efficacy based upon prior clinical trials of mesalamine in patients with mild to moderate active UC as described in the introduction ;


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment


Related Conditions & MeSH terms


NCT number NCT01045018
Study type Interventional
Source EMET Pharmaceuticals, LLC
Contact
Status Completed
Phase Phase 3
Start date January 2008
Completion date August 2009

See also
  Status Clinical Trial Phase
Completed NCT01201122 - Once Versus Twice Daily Mesalamine to Induce Remission in Pediatric Ulcerative Colitis Phase 4
Completed NCT01033305 - Oral Ciclosporin for Colonic Release in Ulcerative Colitis (CyColâ„¢) Phase 2
Recruiting NCT05770609 - A Study of SPH3127 in the Treatment of Mild to Moderate Ulcerative Colitis Phase 2
Recruiting NCT01039597 - Safety and Activity of ORE1001 in Subjects With Ulcerative Colitis Phase 1/Phase 2