Clinical trial NCT00350415: A Double Blind Study for the Treatment of Acute Ulcerative Colitis
Official title: A Double-blind, Randomized, 6-week, Parallel-group Design Clinical Trial to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day for the Treatment of Moderately Active Ulcerative Colitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: ulcerative colitis, inflammatory bowel disease
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2006-07-10
Enrollment: 772
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Double-blind, Randomized, 6-week, Parallel-group Design Clinical trial to assess the Safety and Efficacy of Asacol 4.8 g/day (800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg mesalamine tablet) for the Treatment of Moderately Active Ulcerative Colitis (ASCEND III).

Detailed description: This is a double-blind, randomized, multi-center, multi-national, active-control study in patients who are experiencing a moderately active flare of UC. Patients will be randomly assigned to receive either Asacol 2.4 g/day (400 mg tablet) or Asacol 4.8 g/day (800 mg tablet) for 6 weeks. Patients will be randomized to one of the 2 treatment groups in a 1:1 ratio. The objective of the study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) compared to Asacol 2.4 g/day (400 mg tablet) in this patient population. Following successful screening, patients will be randomized to one of the two treatment arms. Patients will be evaluated after 6 weeks of treatment with an interim visit after 3 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients 18-75 years with a confirmed diagnosis of moderately active flare of ulcerative colitis.
* Female patients need to be postmenopausal or using adequate contraception.

Exclusion Criteria:

* Patients with isolated proctitis
* Patients with comorbidities or an investigative or commercialized treatments confounding interpretation of study results or compromising patients' safety in the trial.

Primary outcomes:
measure: Proportion of patients (ITT) in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6.
timeFrame: Week 6
Secondary outcomes:
measure: Proportion of patients (ITT) in pre-defined subgroups in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6 and Week 3.
timeFrame: week 3 and 6
Other outcomes:
Locations:
city: Alabaster
country: United States
facility: Research Facility
state: Alabama
city: Birmingham
country: United States
facility: Research Facility
state: Alabama
city: Tucson
country: United States
facility: Research Facility
state: Arizona
city: Fayetteville
country: United States
facility: Research Facility
state: Arkansas
city: Little Rock
country: United States
facility: Research Facility
state: Arkansas
city: Anaheim
country: United States
facility: Research Facility
state: California
city: Burbank
country: United States
facility: Research Facility
state: California
city: Encinitas
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: Mission Hills
country: United States
facility: Research Facility
state: California
city: Orange
country: United States
facility: Research Facility
state: California
city: Pasadena
country: United States
facility: Research Facility
state: California
city: Roseville
country: United States
facility: Research Facility
state: California
city: Sacramento
country: United States
facility: Research Facility
state: California
city: San Carlos
country: United States
facility: Research Facility
state: California
city: San Francisco
country: United States
facility: Research Facility
state: California
city: Lakewood
country: United States
facility: Research Facility
state: Colorado
city: Littleton
country: United States
facility: Research Facility
state: Colorado
city: Hamden
country: United States
facility: Research Facility
state: Connecticut
city: Deland
country: United States
facility: Research Facility
state: Florida
city: Harbor
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: Panama City
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: Savannah
country: United States
facility: Research Facility
state: Georgia
city: Arlington Heights
country: United States
facility: Research Facility
state: Illinois
city: Chicago
country: United States
facility: Research Facility
state: Illinois
city: Topeka
country: United States
facility: Research Facility
state: Kansas
city: Louisville
country: United States
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state: Kentucky
city: Baton Rouge
country: United States
facility: Research Facility
state: Louisiana
city: Shreveport
country: United States
facility: Research Facility
state: Louisiana
city: Baltimore
country: United States
facility: Research Facility
state: Maryland
city: Chevy Chase
country: United States
facility: Research Facility
state: Maryland
city: Reisterstown
country: United States
facility: Research Facility
state: Maryland
city: Boston
country: United States
facility: Research Facility
state: Massachusetts
city: Columbia
country: United States
facility: Research Facility
state: Michigan
city: Minneapolis
country: United States
facility: Research Facility
state: Minnesota
city: Rochester
country: United States
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state: Minnesota
city: Tupelo
country: United States
facility: Research Facility
state: Mississippi
city: Kansas City
country: United States
facility: Research Facility
state: Missouri
city: St. Louis
country: United States
facility: Research Facility
state: Missouri
city: Omaha
country: United States
facility: Research Facility
state: Nebraska
city: Scottsbluff
country: United States
facility: Research Facility
state: Nebraska
city: Egg Harbor Township
country: United States
facility: Research Facility
state: New Jersey
city: Binghamton
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: Huntington
country: United States
facility: Research Facility
state: New York
city: New York
country: United States
facility: Research Facility
state: New York
city: Rochester
country: United States
facility: Research Facility
state: New York
city: Troy
country: United States
facility: Research Facility
state: New York
city: Charlotte
country: United States
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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: Fargo
country: United States
facility: Research Facility
state: North Dakota
city: Akron
country: United States
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state: Ohio
city: Cincinnati
country: United States
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state: Ohio
city: Dayton
country: United States
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state: Ohio
city: Warren
country: United States
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state: Ohio
city: Portland
country: United States
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state: Oregon
city: Beaver Falls
country: United States
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state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: York
country: United States
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state: Pennsylvania
city: Columbia
country: United States
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state: South Carolina
city: Kingsport
country: United States
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state: Tennessee
city: Memphis
country: United States
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state: Tennessee
city: Nashville
country: United States
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state: Tennessee
city: Austin
country: United States
facility: Research Facility
state: Texas
city: San Antonio
country: United States
facility: Research Facility
state: Texas
city: Murray
country: United States
facility: Research Facility
state: Utah
city: Ogden
country: United States
facility: Research Facility
state: Utah
city: Burlington
country: United States
facility: Research Facility
state: Vermont
city: Chesapeake
country: United States
facility: Research Facility
state: Virginia
city: Redmond
country: United States
facility: Research Facility
state: Washington
city: Milwaukee
country: United States
facility: Research Facility
state: Wisconsin
city: Gornel
country: Belarus
facility: Research Facility
state: Gormel
city: Grodno
country: Belarus
facility: Research Facility
city: Minsk
country: Belarus
facility: Research Facility
city: Vitebsk
country: Belarus
facility: Research Facility
city: Edmonton
country: Canada
facility: Research Facility
state: Alberta
city: Abbotsford
country: Canada
facility: Research Facility
state: British Columbia
city: Vancouver
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: London
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: Levis
country: Canada
facility: Research Facility
state: Quebec
city: Longheuil
country: Canada
facility: Research Facility
state: Quebec
city: Montreal
country: Canada
facility: Research Facility
state: Quebec
city: Quebec City
country: Canada
facility: Research Facility
state: Quebec
city: Rimouski
country: Canada
facility: Research Facility
state: Quebec
city: Saskatoon
country: Canada
facility: Research Facility
state: Saskatchewan
city: Quebec
country: Canada
facility: Research Facility
city: Rijeka
country: Croatia
facility: Research Facility
city: Zagreb
country: Croatia
facility: Research Facility
city: Kralove
country: Czech Republic
facility: Research Facility
city: Pavlov
country: Czech Republic
facility: Research Facility
city: Praha 2
country: Czech Republic
facility: Research Facility
city: Strakonice
country: Czech Republic
facility: Research Facility
city: Usti nad Labem
country: Czech Republic
facility: Research Facility
city: Tallinn
country: Estonia
facility: Research Facility
city: Tartu
country: Estonia
facility: Research Facility
city: Argenti Dome ter
country: Hungary
facility: Research Facility
city: Budapest
country: Hungary
facility: Research Facility
city: Nagyerdei krt
country: Hungary
facility: Research Facility
city: Riga
country: Latvia
facility: Research Facility
city: Santariskiu
country: Lithuania
facility: Research Facility
state: Vilnius
city: Kaunas
country: Lithuania
facility: Research Facility
city: Panevezys
country: Lithuania
facility: Research FacilityPanevezys
city: Bydgoszcz
country: Poland
facility: Research Facility
city: Czestochowa
country: Poland
facility: Research Facility
city: Krakow
country: Poland
facility: Research Facility
city: Lodz
country: Poland
facility: Research Facility
city: Pruszkow
country: Poland
facility: Research Facility
city: Sopot
country: Poland
facility: Research Facility
city: Warszawa
country: Poland
facility: Research Facility
city: Wtoctawek
country: Poland
facility: Research Facility
city: San Juan
country: Puerto Rico
facility: Research Facility
city: Bucuresti 1
country: Romania
facility: Research Facility
state: Bucuresti
city: Cluj-napoca
country: Romania
facility: Research Facility
city: Iasi
country: Romania
facility: Research Facility
city: Moscow
country: Russian Federation
facility: Research Facility
state: Mowcow
city: Nizhny Novgorod
country: Russian Federation
facility: Research Facility
city: St. Petersburg
country: Russian Federation
facility: Research Facility
city: Beograd
country: Serbia
facility: Research Facility
city: Novi Sad
country: Serbia
facility: Research Facility
city: Zabolotnogo
country: Ukraine
facility: Research Facility
state: Odesa
city: Kharkiv
country: Ukraine
facility: Research Facility
city: Kyiv
country: Ukraine
facility: Research Facility
city: Simpheropol
country: Ukraine
facility: Research Facility
city: Zaporizhzhya
country: Ukraine
facility: Research Facility
Study officials:
affiliation: Procter and Gamble
name: Piotr Krzeski, MD
role: STUDY_DIRECTOR
References: