drugset / Trial / NCT00408174

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

NCT00408174

Phase 3 Completed 400 enrolled Bausch Health Americas, Inc.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2006-05
Primary completion
2007-07
Completion
2007-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Balsalazide Small molecule 3.3 g

Indications