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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Warner Chilcott
• Treatments: Mesalamine

Criteria

Inclusion Criteria:

• Documented history of ulcerative colitis that has been successfully maintained in remission for at least 3 months prior to study entry

• At least one flare in the past 18 months

• Utilizing a stable maintenance dose of oral Asacol of 1.6 g/day up to 2.4 g/day (stable dose is defined as the same dose for the past 3 months)

• Females must be postmenopausal or surgically sterile or have a negative urine pregnancy test and practice acceptable contraception

Exclusion Criteria:

• History of or current renal disease

• History of hepatic disease

• History of allergy or hypersensitivity to salicylates, aminosalicylates

• Treatment with immunomodulatory therapy, biologic therapy or corticosteroids within 90 days of screening

• Received any antidiarrheals, antispasmodics, or antibiotic within 1 month of screening