Trial Information

Summary: 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 3.3G BID vs. Mesalamine (5-ASA) as Asacol 0.8G TID in Mildly to Moderately Active Ulcerative Colitis

The purpose of this study is to demonstrate the efficacy and safety of a new tablet formulation and dosing regimen of balsalazide disodium in achieving clinical improvement in subjects with mildly to moderately active ulcerative colitis.

Inclusion Criteria: Men and women 18 years and older with mildly to moderately actuve ulcerative colitis experiencing symptoms of an acute flare sometime during the past 4 weeks.

Exclusion Criteria: Patients who failed acute therapy with balsalazide disodium or Asacol® within the past 30 days. Patients who have had any prior bowel surgery, except appendectomy. Patients with a history of HIV. Patients with protocol deviations deemed to have a significant impact on efficacy variables will be excluded

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Trial listings updated: June 1, 2008 at 5:46:16 AM