A Randomized, Single-Blind Study to Assess Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily Versus Divided Doses 3 Times Daily for 12 Months in Maintenance of Remission of Ulcerative Colitis. (CODA)

NCT00708656 Phase 3 COMPLETED

The purpose of this study is to compare the safety and effectiveness of dosing mesalazine 800 mg tablets (Asacol®) at 2.4 g once daily versus divided doses three times daily in the maintenance of remission of ulcerative colitis.

Details

Lead sponsor	Cardiff and Vale University Health Board
Phase	Phase 3
Status	COMPLETED
Enrolment	213
Start date	2006-10
Completion	2010-09

Conditions

• Ulcerative Colitis

Interventions

• mesalazine (Asacol®)

Primary outcomes

• To assess whether a once daily dose of three 800mg tablets of mesalazine (Asacol®) in the morning is equivalent to mesalazine (Asacol®) given as 800mg three times daily in preventing relapse over a 12 month period. — At relapse or 12 month follow up

Countries

United Kingdom