Summary:
This is a multicenter randomized trial evaluating the safety and efficacy of a new tablet formulation and dosing regimen of Colazol vs. Asacol in patients with mild to moderate ulcerative colitis. This study is 9 weeks in duration, with an additional 24 months of open label therapy.
Qualified Participants Must:
Be 18 years of age or older
Be male or female
Have mild to moderate ulcerative colitis as defined as blood in stool for 50% of the time
Have not taken greater than 4.8 grms/day of asacol
Qualified Participants May Receive:
For all study visits, medication and compensation for time and travel. Extension study is available for 24 months of study medication.