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

Ulcerative Colitis Clinical Trial

Official title:

A Multi-center, Investigator-blinded, Randomized, 12-month, Parallel-group, Non-inferiority Study to Compare the Efficacy of 1.6 to 2.4 g Asacol® Therapy QD Versus Divided Dose (BID) in the Maintenance of Remission of Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00505778
• Other study ID #: 2007021
• Status: Completed
• Phase: Phase 3
• First received: July 20, 2007
• Last updated: April 15, 2013
• Start date: July 2007
• Est. completion date: July 2009

Study information

• Verified date: April 2013
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1027
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Mesalamine Once-Daily
Mesalamine tablets, 1.6-2.4 g/day taken orally once a day for 52 weeks
• Mesalamine Twice-Daily
Mesalamine tablets, 1.6-2.4 g/day, taken twice daily for 52 weeks

Locations

Country	Name	City	State
Canada	Research Facility	Abbotsford	British Columbia
Canada	Research Facility	Guelph	Ontario
Canada	Research Facility	Hamilton	Ontario
Canada	Research Facility	Montreal	Quebec
Canada	Research Facility	Montreal	Quebec
Canada	Research Facility	Ottawa	Ontario
Canada	Research Facility	Quebec
Canada	Research Facility	Quebec
Canada	Research Facility	Toronto	Ontario
Canada	Research Facility	Toronto	Ontario
Puerto Rico	Research Facility	Ponce
Puerto Rico	Research Facility	San Juan
United States	Research Facility	Akron	Ohio
United States	Research Facility	Albuquerque	New Mexico
United States	Research Facility	Alexandria	Louisiana
United States	Research Facility	Alexandria	Virginia
United States	Research Facility	Allentown	Pennsylvania
United States	Research Facility	Amarillo	Texas
United States	Research Facility	Anaheim	California
United States	Research Facility	Anderson	Indiana
United States	Research Facility	Arlington Heights	Illinois
United States	Research Facility	Athens	Alabama
United States	Research Facility	Atlanta	Georgia
United States	Research Facility	Aventura	Florida
United States	Research Facility	Babylon	New York
United States	Research Facility	Bangor	Maine
United States	Research Facility	Beaver Falls	Pennsylvania
United States	Research Facility	Berwyn	Illinois
United States	Research Facility	Beverly Hills	California
United States	Research Facility	Binghamton	New York
United States	Research Facility	Birmingham	Alabama
United States	Research Facility	Birmingham	Alabama
United States	Research Facility	Bismarck	North Dakota
United States	Research Facility	Bloomington	Indiana
United States	Research Facility	Boise	Idaho
United States	Research Facility	Boone	North Carolina
United States	Research Facility	Boston	Massachusetts
United States	Research Facility	Boston	Massachusetts
United States	Research Facility	Bowling Green	Kentucky
United States	Research Facility	Braintree	Massachusetts
United States	Research Facility	Brooklyn	New York
United States	Research Facility	Brooklyn	New York
United States	Research Facility	Camden	New Jersey
United States	Research Facility	Canton	Ohio
United States	Research Facility	Cape Girardeau	Missouri
United States	Research Facility	Cedar Knolls	New Jersey
United States	Research Facility	Charlotte	North Carolina
United States	Research Facility	Cheektowaga	New York
United States	Research Facility	Chesapeake	Virginia
United States	Research Facility	Chesterfield	Michigan
United States	Research Facility	Chevy Chase	Maryland
United States	Research Facility	Chicago	Illinois
United States	Research Facility	Chico	California
United States	Research Facility	Cincinnati	Ohio
United States	Research Facility	Cincinnati	Ohio
United States	Research Facility	Clairton	Pennsylvania
United States	Research Facility	Cleveland	Ohio
United States	Research Facility	Clive	Iowa
United States	Research Facility	College Park	Maryland
United States	Research Facility	Columbia	Missouri
United States	Research Facility	Columbia	South Carolina
United States	Research Facility	Columbia	South Carolina
United States	Research Facility	Columbus	Georgia
United States	Research Facility	Cortland	New York
United States	Research Facility	Davenport	Iowa
United States	Research Facility	Dayton	Ohio
United States	Research Facility	Dayton	Ohio
United States	Research Facility	Decatur	Georgia
United States	Research Facility	Detroit	Michigan
United States	Research Facility	Dothan	Alabama
United States	Research Facility	Egg Harbor Township	New Jersey
United States	Research Facility	Elgin	Illinois
United States	Research Facility	Encinitas	California
United States	Research Facility	Englewood	Colorado
United States	Research Facility	Fairfax	Virginia
United States	Research Facility	Folsum	California
United States	Research Facility	Forest Hills	New York
United States	Research Facility	Fort Lauderdale	Florida
United States	Research Facility	Fort Worth	Texas
United States	Research Facility	Gainesville	Florida
United States	Research Facility	Garden City	New York
United States	Research Facility	Golden	Colorado
United States	Research Facility	Great Neck	New York
United States	Research Facility	Great Neck	New York
United States	Research Facility	Greenbelt	Maryland
United States	Research Facility	Greensboro	North Carolina
United States	Research Facility	Greenville	North Carolina
United States	Research Facility	Greenville	Texas
United States	Research Facility	Greer	South Carolina
United States	Research Site	Hackensack	New Jersey
United States	Research Facility	Hagerstown	Maryland
United States	Research Facility	Hartford	Connecticut
United States	Research Facility	Highland Park	Illinois
United States	Research Facility	Hoffman Estates	Illinois
United States	Research Facility	Hollywood	Florida
United States	Research Facility	Hollywood	Maryland
United States	Research Facility	Homewood	Illinois
United States	Research Facility	Houston	Texas
United States	Research Facility	Houston	Texas
United States	Research Facility	Houston	Texas
United States	Research Facility	Idaho Falls	Idaho
United States	Research Facility	Indiana	Pennsylvania
United States	Research Facility	Indianapolis	Indiana
United States	Research Facility	Indianapolis	Indiana
United States	Research Facility	Jackson	Tennessee
United States	Research Facility	Jackson	Tennessee
United States	Research Facility	Jacksonville	North Carolina
United States	Research Facility	Jacksonville	Florida
United States	Research Facility	Jacksonville	Florida
United States	Research Facility	Jefferson City	Missouri
United States	Research Facility	Kalamazoo	Michigan
United States	Research Facility	Kinston	North Carolina
United States	Research Facility	La Mesa	California
United States	Research Facility	Lafayette	Colorado
United States	Research Facility	Lafayette	Louisiana
United States	Research Facility	Lake Barrington	Illinois
United States	Research Facility	Lake Success	New York
United States	Research Facility	Lancaster	California
United States	Research Facility	Lancaster	Pennsylvania
United States	Research Facility	Largo	Florida
United States	Research Facility	Las Vegas	Nevada
United States	Research Facility	Lewisville	Texas
United States	Research Facility	Little Rock	Arkansas
United States	Research Facility	Long Beach	California
United States	Research Facility	Longview	Texas
United States	Research Facility	Los Angeles	California
United States	Research Facility	Los Angeles	California
United States	Research Facility	Louisville	Kentucky
United States	Research Facility	Louisville	Kentucky
United States	Research Facility	Lowell	Arkansas
United States	Research Facility	Lutherville	Maryland
United States	Research Facility	Madera	California
United States	Research Facility	Maitland	Florida
United States	Research Facility	Marietta	Georgia
United States	Research Facility	Marietta	Georgia
United States	Research Facility	Memphis	Tennessee
United States	Research Facility	Mentor	Ohio
United States	Research Facility	Merced	California
United States	Research Facility	Meriden	Connecticut
United States	Research Facility	Metairie	Louisiana
United States	Research Facility	Mexico	Missouri
United States	Research Facility	Milwaukee	Wisconsin
United States	Research Facility	Mission Hills	California
United States	Research Facility	Monroe	Louisiana
United States	Research Facility	Monroe	Wisconsin
United States	Research Facility	Monterey	California
United States	Research Facility	Morganton	North Carolina
United States	Research Facility	Morristown	Tennessee
United States	Research Facility	Mt Airy	North Carolina
United States	Research Facility	Murrieta	California
United States	Research Facility	Naples	Florida
United States	Research Facility	New Haven	Connecticut
United States	Research Facility	New Port Richey	Florida
United States	Research Facility	New York	New York
United States	Research Facility	New York	New York
United States	Research Facility	Newbern	North Carolina
United States	Research Facility	Newnan	Georgia
United States	Research Facility	Norfolk	Virginia
United States	Research Facility	North Miami Beach	Florida
United States	Research Facility	Norwalk	Connecticut
United States	Research Facility	Oak Lawn	Illinois
United States	Research Facility	Oakland	California
United States	Research Facility	Ocean	New Jersey
United States	Research Facility	Odessa	Texas
United States	Research Facility	Ogden	Utah
United States	Research Facility	Orange	California
United States	Research Facility	Orlando	Florida
United States	Research Facility	Palm Harbor	Florida
United States	Research Facility	Palm Springs	California
United States	Research Facility	Pasadena	Texas
United States	Research Facility	Peoria	Illinois
United States	Research Facility	Philadelphia	Pennsylvania
United States	Research Facility	Phoenix	Arizona
United States	Research Facility	Phoenixville	Pennsylvania
United States	Research Facility	Pinehurst	North Carolina
United States	Research Facility	Pittsburgh	Pennsylvania
United States	Research Facility	Pittsburgh	Pennsylvania
United States	Research Facility	Pittsford	New York
United States	Research Facility	Plano	Texas
United States	Research Facility	Port Jefferson Station	New York
United States	Research Facility	Port Orange	Florida
United States	Research Facility	Portland	Oregon
United States	Research Facility	Pratt	Kansas
United States	Research Facility	Pueblo	Colorado
United States	Research Facility	Raleigh	North Carolina
United States	Research Facility	Reisterstown	Maryland
United States	Research Facility	Rochester	Minnesota
United States	Research Facility	Rochester	New York
United States	Research Facility	Rochester	New York
United States	Research Facility	Rockville	Maryland
United States	Research Facility	Rockville	Maryland
United States	Research Facility	Salt Lake City	Utah
United States	Research Facility	San Antonio	Texas
United States	Research Facility	San Carlos	California
United States	Research Facility	San Diego	California
United States	Research Facility	San Diego	California
United States	Research Facility	San Diego	California
United States	Research Facility	San Francisco	California
United States	Research Facility	San Francisco	California
United States	Research Facility	Savannah	Georgia
United States	Research Facility	Scottsdale	Arizona
United States	Research Facility	Seattle	Washington
United States	Research Facility	Sewickley	Pennsylvania
United States	Research Facility	Shreveport	Louisiana
United States	Research Facility	Somersworth	New Hampshire
United States	Research Facility	Souderton	Pennsylvania
United States	Research Facility	South Bend	Indiana
United States	Research Facility	South Plainfield	New Jersey
United States	Research Facility	Southbridge	Massachusetts
United States	Research Facility	Spokane	Washington
United States	Research Facility	St Louis	Missouri
United States	Research Facility	St Petersburg	Florida
United States	Research Facility	St. Petersburg	Florida
United States	Research Facility	Tacoma	Washington
United States	Research Facility	Tallahassee	Florida
United States	Research Facility	Tampa	Florida
United States	Research Facility	Tampa	Florida
United States	Research Facility	Toledo	Ohio
United States	Research Facility	Topeka	Kansas
United States	Research Facility	Torrance	California
United States	Research Facility	Torrance	California
United States	Research Facility	Torrington	Connecticut
United States	Research Facility	Trinity	Florida
United States	Research Facility	Troy	Michigan
United States	Research Facility	Tucson	Arizona
United States	Research Facility	Tulsa	Oklahoma
United States	Research Facility	Tupelo	Mississippi
United States	Research Facility	Tuscon	Arizona
United States	Research Facility	Uniontown	Pennsylvania
United States	Research Facility	Upland	California
United States	Research Facility	Urbana	Illinois
United States	Research Facility	Virginia Beach	Virginia
United States	Research Facility	Warwick	Rhode Island
United States	Research Facility	Washington	District of Columbia
United States	Research Facility	Waterloo	Iowa
United States	Research Facility	Wenatchee	Washington
United States	Research Facility	West Bloomfied	Michigan
United States	Research Facility	West Valley City	Utah
United States	Research Facility	Westlake	Ohio
United States	Research Site	Whichita	Kansas
United States	Research Facility	Wilmington	North Carolina
United States	Research Facility	Winchester	Virginia
United States	Research Facility	Winter Park	Florida
United States	Research Facility	Wyoming	Michigan
United States	Research Facility	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI)	Remission defined as SCCAI <5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).	6 months	Yes
Secondary	Percentage of Patients Remaining in Remission at Month 3, ITT Population	Remission defined as SCCAI < 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).	3 months	No
Secondary	Percentage of Patients Remaining in Remission at Month 12, ITT Population	Remission defined as SCCAI score < 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).	12 months	No
Secondary	Number of Subjects Who Relapse/Flare Within 6 Months, ITT Population	Relapse/flare is defined as SCCAI >= 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).	6 months	Yes
Secondary	Total MARS (Medication Adherence Report Scale) Questionnaire Scores, ITT Population, Month 6	MARS: Composite score for the following statements: I change how many times per day I take my medicine, I forget to use it, I stop taking it for a while, I only use it when I am having active symptoms, I decide to miss out on a dose, I take less than instructed, I take more than instructed, I avoid using it if I can, I use it regularly every day (reverse scored): 5-never, 4-rarely, 3-sometimes, 2-often, 1-very often. Minimum score 9, maximum score 45.	6 months	No
Secondary	Percentage of Participants Indicating Ulcerative Colitis in Remission (Patient Defined Remission Index), ITT Population, Month 6	Is your ulcerative colitis in remission (not active)? Y/N	6 months	No