NCT00505778

A Comparison of Once a Day Dose Compared to 2 Doses/Day

A Multi-center, Investigator-blinded, Randomized, 12-month, Parallel-group, Non-inferiority Study to Compare the Efficacy of 1.6 to 2.4 g Asacol® Therapy QD Versus Divided Dose (BID) in the Maintenance of Remission of Ulcerative Colitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,027 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Mesalamine Once-Daily	Mesalamine tablets, 1.6-2.4 g/day taken orally once a day for 52 weeks
DRUG	Mesalamine Twice-Daily	Mesalamine tablets, 1.6-2.4 g/day, taken twice daily for 52 weeks

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2007-07-23
• Last updated: 2013-04-22
• Results posted: 2011-05-12

Locations

245 sites across 3 countries: United States, Canada, Puerto Rico