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

Warner Chilcott

Status and phase: Completed; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: Mesalamine Once-Daily; Drug: Mesalamine Twice-Daily

Study type: Interventional

Funder types: Industry

Identifiers

NCT00505778

2007021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,027 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,027 participants in 2 patient groups

Mesalamine (Asacol) Once-Daily

Active Comparator group

Description:

an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)

Treatment:

Drug: Mesalamine Once-Daily

Mesalamine (Asacol) Twice-Daily

Active Comparator group

Description:

an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)

Treatment:

Drug: Mesalamine Twice-Daily