Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)

Warner Chilcott

Status and phase: Completed; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: mesalamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00577473

2000083

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) versus Asacol 2.4 g/day (400 mg tablet

Full description

This study is designed to evaluate the safety and efficacy of 4.8 g/day using 800 mg Asacol tablets as compared to 2.4g/day using 400 mg Asacol tablets in newly- and previously-diagnosed patients who are experiencing a flare-up of mildly to moderately active ulcerative colitis.

Enrollment: 301 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• confirmed diagnosis of ulcerative colitis

Exclusion criteria

• a history of allergy or hypersensitivity to salicylates or aminosalicylates;
• a history of extensive small bowel resection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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301 participants in 2 patient groups

1

Active Comparator group

Description:

mesalamine 2.4 g/day (400 mg tablet) for 6 weeks

Treatment:

Drug: mesalamine

Drug: mesalamine

2

Experimental group

Description:

mesalamine 4.8 g/day (800 mg tablet) for 6 weeks

Treatment:

Drug: mesalamine

Drug: mesalamine