Clinical trial NCT00713310: Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis
Official title: Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8 g/Day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents With Mildly-to-Moderately Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2008-07-11
Enrollment: 83
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall objective of this study is to assess the safety and efficacy of high dose and low dose Asacol administered as 400 mg delayed-release tablets given every 12 hours for 6 weeks to children and adolescents with mildly-to-moderately active ulcerative colitis.


Eligibility criteria: Inclusion Criteria:

* are male or female between the ages of 5 and 17 years, inclusive, at the time of the first dose of study medication, with a history of biopsy and endoscopy confirmed UC;
* have mildly-to-moderately active UC (either newly diagnosed or that has relapsed) as defined clinically by a Pediatric UC Activity Index (PUCAI) score 10 and 55, and, in the opinion of the Investigator, the patient does not require steroids;
* have baseline scores of at least 1 for both rectal bleeding (Streaks of blood with stool less than half of the time) and stool frequency (1-2 stools greater than normal per day) as defined by the TM-Mayo Score

Exclusion Criteria:

* have UC known to be confined to the rectum (isolated rectal proctitis);
* have a history of allergy or hypersensitivity to salicylates, aminosalicylates, or any component of the Asacol tablet;
* have a significant co-existing illness or other condition(s), including but not limited to cancer or significant organic or psychiatric disease on medical history or physical examination, that, in the judgment of the Investigator, contraindicate(s) administration of the study drug and/or any study procedures

Primary outcomes:
measure: Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT
timeFrame: Baseline and Week 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Facility
state: Alabama
city: Phoenix
country: United States
facility: Research Facility
state: Arizona
city: Loma Linda
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: Washington
country: United States
facility: Research Facility
state: District of Columbia
city: Gainesville
country: United States
facility: Research Facility
state: Florida
city: Park Ridge
country: United States
facility: Research Facility
state: Illinois
city: Louisville
country: United States
facility: Research Facility
state: Kentucky
city: Boston
country: United States
facility: Research Facility
state: Massachusetts
city: Worcester
country: United States
facility: Research Facility
state: Massachusetts
city: Kansas City
country: United States
facility: Research Facility
state: Missouri
city: Omaha
country: United States
facility: Research Facility
state: Nebraska
city: Mays Landing
country: United States
facility: Research Facility
state: New Jersey
city: Buffalo
country: United States
facility: Research Facility
state: New York
city: New Hyde Park
country: United States
facility: Research Facility
state: New York
city: Youngstown
country: United States
facility: Research Facility
state: Ohio
city: Portland
country: United States
facility: Research Facility
state: Oregon
city: Chattanooga
country: United States
facility: Research Facility
state: Tennessee
city: Knoxville
country: United States
facility: Research Facility
state: Tennessee
city: Fort Worth
country: United States
facility: Research Facility
state: Texas
city: Houston
country: United States
facility: Research Facility
state: Texas
city: San Antonio
country: United States
facility: Research Facility
state: Texas
city: Norfolk
country: United States
facility: Research Facility
state: Virginia
city: Huntington
country: United States
facility: Research Facility
state: West Virginia
city: Halifax
country: Canada
facility: Research Facility
state: Nova Scotia
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: Montreal
country: Canada
facility: Research Facility
state: Quebec
city: Rijeka
country: Croatia
facility: Research Site
city: Zagreb
country: Croatia
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Warsazawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
Study officials:
affiliation: Procter and Gamble
name: Preston M Dunnmon, MD
role: STUDY_DIRECTOR
References:
citation: Winter HS, Krzeski P, Heyman MB, Ibarguen-Secchia E, Iwanczak B, Kaczmarski M, Kierkus J, Kolacek S, Osuntokun B, Quiros JA, Shah M, Yacyshyn B, Dunnmon PM. High- and low-dose oral delayed-release mesalamine in children with mild-to-moderately active ulcerative colitis. J Pediatr Gastroenterol Nutr. 2014 Dec;59(6):767-72. doi: 10.1097/MPG.0000000000000530.