Conditions: Ulcerative Colitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1027
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the efficacy in maintaining remission of ulcerative colitis between a once daily (QD) Asacol regimen and a divided, twice daily (BID) Asacol dosing regimen.

Detailed description:
Currently, in the US, Asacol therapy is indicated in divided doses for the maintenance of remission of ulcerative colitis at 1.6 g/day. A once daily dose is potentially beneficial to patients and physicians alike. This study will answer the following questions about once daily dosing: (1) does efficacy differ between once daily and twice daily dosing, (2) do patients prefer a once daily dosing regimen, and (3) is compliance better? This study will confirm whether there are benefits to once daily dosing beyond increased convenience. In order to understand how the QD regimen compares to BID in a "real life" practice setting, the patient will remain on the total daily dose of Asacol (1.6 g/day to 2.4 g/day) on which they were maintained in remission, but will be assigned to either a QD or BID regimen. This is an investigator-blinded study.

Arms:
arm 1: an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day) arm 2: an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)

Interventions: intervention 1: Mesalamine Once-Daily intervention 2: Mesalamine Twice-Daily
Intervention descriptions: intervention 1: Mesalamine tablets, 1.6-2.4 g/day taken orally once a day for 52 weeks intervention 2: Mesalamine tablets, 1.6-2.4 g/day, taken twice daily for 52 weeks

Protocol document: