Clinical trial NCT00577473: Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)
Official title: A Double-blind, Randomized, 6 Week, Parallel-group Design Clinical Trial in Patients With Mildly to Moderately Active Ulcerative Colitis to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2007-12-20
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) versus Asacol 2.4 g/day (400 mg tablet

Detailed description: This study is designed to evaluate the safety and efficacy of 4.8 g/day using 800 mg Asacol tablets as compared to 2.4g/day using 400 mg Asacol tablets in newly- and previously-diagnosed patients who are experiencing a flare-up of mildly to moderately active ulcerative colitis.

Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of ulcerative colitis

Exclusion Criteria:

* a history of allergy or hypersensitivity to salicylates or aminosalicylates;
* a history of extensive small bowel resection

Primary outcomes:
measure: Percentage of Patients Classified as Treatment Success at Week 6, ITT Population
timeFrame: 6 weeks
Secondary outcomes:
measure: Percentage of Patients Classified as Treatment Success at Week 3, ITT Population
timeFrame: 3 weeks
measure: Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 3, All Randomized Patients
timeFrame: Week 3
measure: Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 6, All Randomized Patients
timeFrame: Week 6
measure: Stool Frequency Improvement at Week 3, All Randomized Patients (Percentage)
timeFrame: Week 3
measure: Stool Frequency Improvement at Week 6, All Randomized Patients (Percentage)
timeFrame: Week 6
measure: Rectal Bleeding Improvement at Week 3, All Randomized Patients (Percentage)
timeFrame: Week 3
measure: Rectal Bleeding Improvement at Week 6, All Randomized Patients (Percentage)
timeFrame: Week 6
measure: Improvement in Patient's Functional Assessment (PFA) at Week 3, All Randomized Patients (Percentage)
timeFrame: Week 3
measure: Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage)
timeFrame: Week 6
measure: Improvement in Patient's Sigmoidoscopy Assessment Score at Week 3, All Randomized Patients (Percentage)
timeFrame: Week 3
measure: Improvement in Patient's Sigmoidoscopy Assessment Score at Week 6, All Randomized Patients (Percentage)
timeFrame: Week 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Anaheim
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Golden
country: United States
facility: Research Facility
state: Colorado
city: Bridgeport
country: United States
facility: Research Site
state: Connecticut
city: Ft Myers
country: United States
facility: Research Site
state: Florida
city: Hollywood
country: United States
facility: Research Site
state: Florida
city: Jupiter
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Facility
state: Georgia
city: Decatur
country: United States
facility: Research Facility
state: Georgia
city: Arlington Heights
country: United States
facility: Research Site
state: Illinois
city: Moline
country: United States
facility: Research Site
state: Illinois
city: Rockford
country: United States
facility: Research Site
state: Illinois
city: Wichita
country: United States
facility: Research Site
state: Kansas
city: Metairie
country: United States
facility: Research Site
state: Louisiana
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Laurel
country: United States
facility: Research Site
state: Maryland
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: New Brunswick
country: United States
facility: Research Site
state: New Jersey
city: Somerville
country: United States
facility: Research Site
state: New Jersey
city: Great Neck
country: United States
facility: Research Site
state: New York
city: Pomona
country: United States
facility: Research Site
state: New York
city: Poughkeepsie
country: United States
facility: Research Facility
state: New York
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Tulsa
country: United States
facility: Research Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Memphis
country: United States
facility: Research Facility
state: Tennessee
city: Nashville
country: United States
facility: Research Facility
state: Tennessee
city: Ft Worth
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Burlington
country: United States
facility: Research Site
state: Vermont
city: Charlottesville
country: United States
facility: Research Site
state: Virginia
city: Falls Church
country: United States
facility: Research Facility
state: Virginia
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: Procter and Gamble
name: Jeffery Kralstein, MD
role: STUDY_DIRECTOR
References:
citation: Orchard TR, van der Geest SA, Travis SP. Randomised clinical trial: early assessment after 2 weeks of high-dose mesalazine for moderately active ulcerative colitis - new light on a familiar question. Aliment Pharmacol Ther. 2011 May;33(9):1028-35. doi: 10.1111/j.1365-2036.2011.04620.x. Epub 2011 Mar 8.
citation: Lichtenstein GR, Ramsey D, Rubin DT. Randomised clinical trial: delayed-release oral mesalazine 4.8 g/day vs. 2.4 g/day in endoscopic mucosal healing--ASCEND I and II combined analysis. Aliment Pharmacol Ther. 2011 Mar;33(6):672-8. doi: 10.1111/j.1365-2036.2010.04575.x. Epub 2011 Jan 23.