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

Completed · Phase 3

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT00505778

Run by

Warner Chilcott

People needed

1027

Starts

2007-07-01

Expected to finish

2009-07-01

Last updated by the study team

2013-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Facility — Birmingham, Alabama, United States
• Research Facility — Birmingham, Alabama, United States
• Research Facility — Dothan, Alabama, United States
• Research Facility — Phoenix, Arizona, United States
• Research Facility — Scottsdale, Arizona, United States
• Research Facility — Tucson, Arizona, United States
• Research Facility — Tuscon, Arizona, United States
• Research Facility — Little Rock, Arkansas, United States
• Research Facility — Lowell, Arkansas, United States
• Research Facility — Anaheim, California, United States
• Research Facility — Beverly Hills, California, United States
• Research Facility — Chico, California, United States
• Research Facility — Encinitas, California, United States
• Research Facility — Folsom, California, United States
• Research Facility — La Mesa, California, United States
• Research Facility — Lancaster, California, United States
• Research Facility — Long Beach, California, United States
• Research Facility — Los Angeles, California, United States
• Research Facility — Los Angeles, California, United States
• Research Facility — Madera, California, United States
• Research Facility — Merced, California, United States
• Research Facility — Mission Hills, California, United States
• Research Facility — Monterey, California, United States
• Research Facility — Murrieta, California, United States
• Research Facility — Athens, Alabama, United States

Full record on ClinicalTrials.gov

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