NCT00408174

Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Actively-Controlled Trial to Evaluate the Safety and Efficacy of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium 3.3 g Bid Versus Mesalamine (5-ASA) as Asacol® 0.8 g Tid in Mildly to Moderately Active Ulcerative Colitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To establish the efficacy and safety of a new tablet formulation and dosing regimen of balsalazide disodium dosed twice daily in achieving clinical improvement in subjects with mildly to moderately active ulcerative colitis after 6 weeks of therapy.

Conditions

• Inflammatory Bowel Disease
• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Balsalazide disodium

Timeline

• Start date: 2006-05-01
• Primary completion: 2007-07-01
• Completion: 2007-11-01
• First posted: 2006-12-06
• Last updated: 2019-11-25

Locations

88 sites across 1 country: United States