Clinical trial NCT00505778: A Comparison of Once a Day Dose Compared to 2 Doses/Day
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2007-07-23
Enrollment: 1027
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI)
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of Patients Remaining in Remission at Month 3, ITT Population
timeFrame: 3 months
measure: Percentage of Patients Remaining in Remission at Month 12, ITT Population
timeFrame: 12 months
measure: Number of Subjects Who Relapse/Flare Within 6 Months, ITT Population
timeFrame: 6 months
measure: Total MARS (Medication Adherence Report Scale) Questionnaire Scores, ITT Population, Month 6
timeFrame: 6 months
measure: Percentage of Participants Indicating Ulcerative Colitis in Remission (Patient Defined Remission Index), ITT Population, Month 6
timeFrame: 6 months
Other outcomes:
Locations:
city: Athens
country: United States
facility: Research Facility
state: Alabama
city: Birmingham
country: United States
facility: Research Facility
state: Alabama
city: Birmingham
country: United States
facility: Research Facility
state: Alabama
city: Dothan
country: United States
facility: Research Facility
state: Alabama
city: Phoenix
country: United States
facility: Research Facility
state: Arizona
city: Scottsdale
country: United States
facility: Research Facility
state: Arizona
city: Tucson
country: United States
facility: Research Facility
state: Arizona
city: Tuscon
country: United States
facility: Research Facility
state: Arizona
city: Little Rock
country: United States
facility: Research Facility
state: Arkansas
city: Lowell
country: United States
facility: Research Facility
state: Arkansas
city: Anaheim
country: United States
facility: Research Facility
state: California
city: Beverly Hills
country: United States
facility: Research Facility
state: California
city: Chico
country: United States
facility: Research Facility
state: California
city: Encinitas
country: United States
facility: Research Facility
state: California
city: Folsum
country: United States
facility: Research Facility
state: California
city: La Mesa
country: United States
facility: Research Facility
state: California
city: Lancaster
country: United States
facility: Research Facility
state: California
city: Long Beach
country: United States
facility: Research Facility
state: California
city: Los Angeles
country: United States
facility: Research Facility
state: California
city: Los Angeles
country: United States
facility: Research Facility
state: California
city: Madera
country: United States
facility: Research Facility
state: California
city: Merced
country: United States
facility: Research Facility
state: California
city: Mission Hills
country: United States
facility: Research Facility
state: California
city: Monterey
country: United States
facility: Research Facility
state: California
city: Murrieta
country: United States
facility: Research Facility
state: California
city: Oakland
country: United States
facility: Research Facility
state: California
city: Orange
country: United States
facility: Research Facility
state: California
city: Palm Springs
country: United States
facility: Research Facility
state: California
city: San Carlos
country: United States
facility: Research Facility
state: California
city: San Diego
country: United States
facility: Research Facility
state: California
city: San Diego
country: United States
facility: Research Facility
state: California
city: San Diego
country: United States
facility: Research Facility
state: California
city: San Francisco
country: United States
facility: Research Facility
state: California
city: San Francisco
country: United States
facility: Research Facility
state: California
city: Torrance
country: United States
facility: Research Facility
state: California
city: Torrance
country: United States
facility: Research Facility
state: California
city: Upland
country: United States
facility: Research Facility
state: California
city: Englewood
country: United States
facility: Research Facility
state: Colorado
city: Golden
country: United States
facility: Research Facility
state: Colorado
city: Lafayette
country: United States
facility: Research Facility
state: Colorado
city: Pueblo
country: United States
facility: Research Facility
state: Colorado
city: Hartford
country: United States
facility: Research Facility
state: Connecticut
city: Meriden
country: United States
facility: Research Facility
state: Connecticut
city: New Haven
country: United States
facility: Research Facility
state: Connecticut
city: Norwalk
country: United States
facility: Research Facility
state: Connecticut
city: Torrington
country: United States
facility: Research Facility
state: Connecticut
city: Washington
country: United States
facility: Research Facility
state: District of Columbia
city: Aventura
country: United States
facility: Research Facility
state: Florida
city: Fort Lauderdale
country: United States
facility: Research Facility
state: Florida
city: Gainesville
country: United States
facility: Research Facility
state: Florida
city: Hollywood
country: United States
facility: Research Facility
state: Florida
city: Jacksonville
country: United States
facility: Research Facility
state: Florida
city: Jacksonville
country: United States
facility: Research Facility
state: Florida
city: Largo
country: United States
facility: Research Facility
state: Florida
city: Maitland
country: United States
facility: Research Facility
state: Florida
city: Naples
country: United States
facility: Research Facility
state: Florida
city: New Port Richey
country: United States
facility: Research Facility
state: Florida
city: North Miami Beach
country: United States
facility: Research Facility
state: Florida
city: Orlando
country: United States
facility: Research Facility
state: Florida
city: Palm Harbor
country: United States
facility: Research Facility
state: Florida
city: Port Orange
country: United States
facility: Research Facility
state: Florida
city: St Petersburg
country: United States
facility: Research Facility
state: Florida
city: St. Petersburg
country: United States
facility: Research Facility
state: Florida
city: Tallahassee
country: United States
facility: Research Facility
state: Florida
city: Tampa
country: United States
facility: Research Facility
state: Florida
city: Tampa
country: United States
facility: Research Facility
state: Florida
city: Trinity
country: United States
facility: Research Facility
state: Florida
city: Winter Park
country: United States
facility: Research Facility
state: Florida
city: Zephyrhills
country: United States
facility: Research Facility
state: Florida
city: Atlanta
country: United States
facility: Research Facility
state: Georgia
city: Columbus
country: United States
facility: Research Facility
state: Georgia
city: Decatur
country: United States
facility: Research Facility
state: Georgia
city: Marietta
country: United States
facility: Research Facility
state: Georgia
city: Marietta
country: United States
facility: Research Facility
state: Georgia
city: Newnan
country: United States
facility: Research Facility
state: Georgia
city: Savannah
country: United States
facility: Research Facility
state: Georgia
city: Boise
country: United States
facility: Research Facility
state: Idaho
city: Idaho Falls
country: United States
facility: Research Facility
state: Idaho
city: Arlington Heights
country: United States
facility: Research Facility
state: Illinois
city: Berwyn
country: United States
facility: Research Facility
state: Illinois
city: Chicago
country: United States
facility: Research Facility
state: Illinois
city: Elgin
country: United States
facility: Research Facility
state: Illinois
city: Highland Park
country: United States
facility: Research Facility
state: Illinois
city: Hoffman Estates
country: United States
facility: Research Facility
state: Illinois
city: Homewood
country: United States
facility: Research Facility
state: Illinois
city: Lake Barrington
country: United States
facility: Research Facility
state: Illinois
city: Oak Lawn
country: United States
facility: Research Facility
state: Illinois
city: Peoria
country: United States
facility: Research Facility
state: Illinois
city: Urbana
country: United States
facility: Research Facility
state: Illinois
city: Anderson
country: United States
facility: Research Facility
state: Indiana
city: Bloomington
country: United States
facility: Research Facility
state: Indiana
city: Indianapolis
country: United States
facility: Research Facility
state: Indiana
city: Indianapolis
country: United States
facility: Research Facility
state: Indiana
city: South Bend
country: United States
facility: Research Facility
state: Indiana
city: Clive
country: United States
facility: Research Facility
state: Iowa
city: Davenport
country: United States
facility: Research Facility
state: Iowa
city: Waterloo
country: United States
facility: Research Facility
state: Iowa
city: Pratt
country: United States
facility: Research Facility
state: Kansas
city: Topeka
country: United States
facility: Research Facility
state: Kansas
city: Whichita
country: United States
facility: Research Site
state: Kansas
city: Bowling Green
country: United States
facility: Research Facility
state: Kentucky
city: Louisville
country: United States
facility: Research Facility
state: Kentucky
city: Louisville
country: United States
facility: Research Facility
state: Kentucky
city: Alexandria
country: United States
facility: Research Facility
state: Louisiana
city: Lafayette
country: United States
facility: Research Facility
state: Louisiana
city: Metairie
country: United States
facility: Research Facility
state: Louisiana
city: Monroe
country: United States
facility: Research Facility
state: Louisiana
city: Shreveport
country: United States
facility: Research Facility
state: Louisiana
city: Bangor
country: United States
facility: Research Facility
state: Maine
city: Chevy Chase
country: United States
facility: Research Facility
state: Maryland
city: College Park
country: United States
facility: Research Facility
state: Maryland
city: Greenbelt
country: United States
facility: Research Facility
state: Maryland
city: Hagerstown
country: United States
facility: Research Facility
state: Maryland
city: Hollywood
country: United States
facility: Research Facility
state: Maryland
city: Lutherville
country: United States
facility: Research Facility
state: Maryland
city: Reisterstown
country: United States
facility: Research Facility
state: Maryland
city: Rockville
country: United States
facility: Research Facility
state: Maryland
city: Rockville
country: United States
facility: Research Facility
state: Maryland
city: Boston
country: United States
facility: Research Facility
state: Massachusetts
city: Boston
country: United States
facility: Research Facility
state: Massachusetts
city: Braintree
country: United States
facility: Research Facility
state: Massachusetts
city: Southbridge
country: United States
facility: Research Facility
state: Massachusetts
city: Chesterfield
country: United States
facility: Research Facility
state: Michigan
city: Detroit
country: United States
facility: Research Facility
state: Michigan
city: Kalamazoo
country: United States
facility: Research Facility
state: Michigan
city: Troy
country: United States
facility: Research Facility
state: Michigan
city: West Bloomfied
country: United States
facility: Research Facility
state: Michigan
city: Wyoming
country: United States
facility: Research Facility
state: Michigan
city: Rochester
country: United States
facility: Research Facility
state: Minnesota
city: Tupelo
country: United States
facility: Research Facility
state: Mississippi
city: Cape Girardeau
country: United States
facility: Research Facility
state: Missouri
city: Columbia
country: United States
facility: Research Facility
state: Missouri
city: Jefferson City
country: United States
facility: Research Facility
state: Missouri
city: Mexico
country: United States
facility: Research Facility
state: Missouri
city: St Louis
country: United States
facility: Research Facility
state: Missouri
city: Las Vegas
country: United States
facility: Research Facility
state: Nevada
city: Somersworth
country: United States
facility: Research Facility
state: New Hampshire
city: Camden
country: United States
facility: Research Facility
state: New Jersey
city: Cedar Knolls
country: United States
facility: Research Facility
state: New Jersey
city: Egg Harbor Township
country: United States
facility: Research Facility
state: New Jersey
city: Hackensack
country: United States
facility: Research Site
state: New Jersey
city: Ocean
country: United States
facility: Research Facility
state: New Jersey
city: South Plainfield
country: United States
facility: Research Facility
state: New Jersey
city: Albuquerque
country: United States
facility: Research Facility
state: New Mexico
city: Babylon
country: United States
facility: Research Facility
state: New York
city: Binghamton
country: United States
facility: Research Facility
state: New York
city: Brooklyn
country: United States
facility: Research Facility
state: New York
city: Brooklyn
country: United States
facility: Research Facility
state: New York
city: Cheektowaga
country: United States
facility: Research Facility
state: New York
city: Cortland
country: United States
facility: Research Facility
state: New York
city: Forest Hills
country: United States
facility: Research Facility
state: New York
city: Garden City
country: United States
facility: Research Facility
state: New York
city: Great Neck
country: United States
facility: Research Facility
state: New York
city: Great Neck
country: United States
facility: Research Facility
state: New York
city: Lake Success
country: United States
facility: Research Facility
state: New York
city: New York
country: United States
facility: Research Facility
state: New York
city: New York
country: United States
facility: Research Facility
state: New York
city: Pittsford
country: United States
facility: Research Facility
state: New York
city: Port Jefferson Station
country: United States
facility: Research Facility
state: New York
city: Rochester
country: United States
facility: Research Facility
state: New York
city: Rochester
country: United States
facility: Research Facility
state: New York
city: Boone
country: United States
facility: Research Facility
state: North Carolina
city: Charlotte
country: United States
facility: Research Facility
state: North Carolina
city: Greensboro
country: United States
facility: Research Facility
state: North Carolina
city: Greenville
country: United States
facility: Research Facility
state: North Carolina
city: Jacksonville
country: United States
facility: Research Facility
state: North Carolina
city: Kinston
country: United States
facility: Research Facility
state: North Carolina
city: Morganton
country: United States
facility: Research Facility
state: North Carolina
city: Mt Airy
country: United States
facility: Research Facility
state: North Carolina
city: Newbern
country: United States
facility: Research Facility
state: North Carolina
city: Pinehurst
country: United States
facility: Research Facility
state: North Carolina
city: Raleigh
country: United States
facility: Research Facility
state: North Carolina
city: Wilmington
country: United States
facility: Research Facility
state: North Carolina
city: Bismarck
country: United States
facility: Research Facility
state: North Dakota
city: Akron
country: United States
facility: Research Facility
state: Ohio
city: Canton
country: United States
facility: Research Facility
state: Ohio
city: Cincinnati
country: United States
facility: Research Facility
state: Ohio
city: Cincinnati
country: United States
facility: Research Facility
state: Ohio
city: Cleveland
country: United States
facility: Research Facility
state: Ohio
city: Dayton
country: United States
facility: Research Facility
state: Ohio
city: Dayton
country: United States
facility: Research Facility
state: Ohio
city: Mentor
country: United States
facility: Research Facility
state: Ohio
city: Toledo
country: United States
facility: Research Facility
state: Ohio
city: Westlake
country: United States
facility: Research Facility
state: Ohio
city: Tulsa
country: United States
facility: Research Facility
state: Oklahoma
city: Portland
country: United States
facility: Research Facility
state: Oregon
city: Allentown
country: United States
facility: Research Facility
state: Pennsylvania
city: Beaver Falls
country: United States
facility: Research Facility
state: Pennsylvania
city: Clairton
country: United States
facility: Research Facility
state: Pennsylvania
city: Indiana
country: United States
facility: Research Facility
state: Pennsylvania
city: Lancaster
country: United States
facility: Research Facility
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Facility
state: Pennsylvania
city: Phoenixville
country: United States
facility: Research Facility
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Facility
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Facility
state: Pennsylvania
city: Sewickley
country: United States
facility: Research Facility
state: Pennsylvania
city: Souderton
country: United States
facility: Research Facility
state: Pennsylvania
city: Uniontown
country: United States
facility: Research Facility
state: Pennsylvania
city: Warwick
country: United States
facility: Research Facility
state: Rhode Island
city: Columbia
country: United States
facility: Research Facility
state: South Carolina
city: Columbia
country: United States
facility: Research Facility
state: South Carolina
city: Greer
country: United States
facility: Research Facility
state: South Carolina
city: Jackson
country: United States
facility: Research Facility
state: Tennessee
city: Jackson
country: United States
facility: Research Facility
state: Tennessee
city: Memphis
country: United States
facility: Research Facility
state: Tennessee
city: Morristown
country: United States
facility: Research Facility
state: Tennessee
city: Amarillo
country: United States
facility: Research Facility
state: Texas
city: Fort Worth
country: United States
facility: Research Facility
state: Texas
city: Greenville
country: United States
facility: Research Facility
state: Texas
city: Houston
country: United States
facility: Research Facility
state: Texas
city: Houston
country: United States
facility: Research Facility
state: Texas
city: Houston
country: United States
facility: Research Facility
state: Texas
city: Lewisville
country: United States
facility: Research Facility
state: Texas
city: Longview
country: United States
facility: Research Facility
state: Texas
city: Odessa
country: United States
facility: Research Facility
state: Texas
city: Pasadena
country: United States
facility: Research Facility
state: Texas
city: Plano
country: United States
facility: Research Facility
state: Texas
city: San Antonio
country: United States
facility: Research Facility
state: Texas
city: Ogden
country: United States
facility: Research Facility
state: Utah
city: Salt Lake City
country: United States
facility: Research Facility
state: Utah
city: West Valley City
country: United States
facility: Research Facility
state: Utah
city: Alexandria
country: United States
facility: Research Facility
state: Virginia
city: Chesapeake
country: United States
facility: Research Facility
state: Virginia
city: Fairfax
country: United States
facility: Research Facility
state: Virginia
city: Norfolk
country: United States
facility: Research Facility
state: Virginia
city: Virginia Beach
country: United States
facility: Research Facility
state: Virginia
city: Winchester
country: United States
facility: Research Facility
state: Virginia
city: Seattle
country: United States
facility: Research Facility
state: Washington
city: Spokane
country: United States
facility: Research Facility
state: Washington
city: Tacoma
country: United States
facility: Research Facility
state: Washington
city: Wenatchee
country: United States
facility: Research Facility
state: Washington
city: Milwaukee
country: United States
facility: Research Facility
state: Wisconsin
city: Monroe
country: United States
facility: Research Facility
state: Wisconsin
city: Abbotsford
country: Canada
facility: Research Facility
state: British Columbia
city: Guelph
country: Canada
facility: Research Facility
state: Ontario
city: Hamilton
country: Canada
facility: Research Facility
state: Ontario
city: Ottawa
country: Canada
facility: Research Facility
state: Ontario
city: Toronto
country: Canada
facility: Research Facility
state: Ontario
city: Toronto
country: Canada
facility: Research Facility
state: Ontario
city: Montreal
country: Canada
facility: Research Facility
state: Quebec
city: Montreal
country: Canada
facility: Research Facility
state: Quebec
city: Quebec
country: Canada
facility: Research Facility
city: Quebec
country: Canada
facility: Research Facility
city: Ponce
country: Puerto Rico
facility: Research Facility
city: San Juan
country: Puerto Rico
facility: Research Facility
Study officials:
affiliation: Procter and Gamble
name: Tom G Todaro, MD
role: STUDY_DIRECTOR
References:
citation: Sandborn WJ, Korzenik J, Lashner B, Leighton JA, Mahadevan U, Marion JF, Safdi M, Sninsky CA, Patel RM, Friedenberg KA, Dunnmon P, Ramsey D, Kane S. Once-daily dosing of delayed-release oral mesalamine (400-mg tablet) is as effective as twice-daily dosing for maintenance of remission of ulcerative colitis. Gastroenterology. 2010 Apr;138(4):1286-96, 1296.e1-3. doi: 10.1053/j.gastro.2009.12.054. Epub 2010 Jan 11.