*A 6-week, multicenter, randomized, double-blind, active-controlled study to assess the noninferiority of ASACOL HD 4.8 g/d (800 mg tablet) compared with mesalamine delayed-release 2.4 g/d (400 mg tablet) in 772 patients with moderately active UC. The primary endpoint was treatment success (overall improvement) at week 6, defined as improvement in the PGA (based on clinical assessments of rectal bleeding, stool frequency, and sigmoidoscopy), with no worsening in any individual clinical assessment.3
†A 6-week, double-blind, randomized, multicenter, active-controlled study to evaluate the safety and efficacy of ASACOL HD 4.8 g/d (800 mg tablet) vs mesalamine delayed-release 2.4 g/d (400 mg tablet) in patients with moderately active UC. Patients were randomly assigned to receive either mesalamine delayed-release 2.4 g/d (400 mg tablet) or ASACOL HD 4.8 g/d (800 mg tablet). Up to 386 patients were enrolled in the study, of whom approximately 268 were patients with moderately active disease. The primary efficacy endpoint for this study was the treatment outcome at the end of the study (ie, treatment success or failure at week 6) for patients with moderate disease at baseline. Treatment success was defined as either a complete or partial response to treatment.4
‡P=NS.3
§P<0.05 between 4.8 g/d and 2.4 g/d.4
ASACOL® HD (mesalamine) delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis (UC) in adults. The safety and effectiveness of ASACOL HD beyond 6 weeks have not been established.
ASACOL® HD (mesalamine) delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis (UC) in adults. The safety and effectiveness of ASACOL HD beyond 6 weeks have not been established.
Please see full Prescribing Information for ASACOL HD.
ASACOL® HD (mesalamine) delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis (UC) in adults. The safety and effectiveness of ASACOL HD beyond 6 weeks have not been established.
ASACOL® HD (mesalamine) delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis (UC) in adults. The safety and effectiveness of ASACOL HD beyond 6 weeks have not been established.
Please see full Prescribing Information for ASACOL HD.
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