Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis
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
1 other identifier
interventional
83
5 countries
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2008
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2008
CompletedFirst Posted
Study publicly available on registry
July 11, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
April 4, 2012
CompletedApril 5, 2012
April 1, 2012
2.2 years
July 9, 2008
March 6, 2012
April 3, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population
PUCAI 0-85, abdominal pain (no pain/0, pain ignored/5, pain not ignored/10), rectal bleeding (none/0, small \<50% stool/10, small with most stools/20, large \>50% stool/30), stool consistency (formed/0, partially/5, unformed/10), # per 24 hrs (0-2/0, 3-5/5, 6-8/10, \>8/15), nocturnal bowel movements (no/0, yes/10), activity level (no limitation/0, occasional limitation/5, severely restricted/10) Remission \<10, Mild 10-34, Moderate 35-64, Severe 65-85, Success score\<10 at Wk 6 (complete) or reduction of \>=20 points baseline to Wk 6 with Wk 6 score\>=10 (partial)
Baseline and 6 weeks
Secondary Outcomes (1)
Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT
Baseline and Week 6
Study Arms (2)
Low-Dose
EXPERIMENTAL1.2 - 2.4 g/day Asacol dependent on body weight
High-Dose
EXPERIMENTAL2.0 - 4.8 g/day Asacol dependent on body weight
Interventions
High dose: 17-\<33 kg = 3 Asacol 400mg in morning and 2 Asacol 400 in PM, 33-\<54 kg = 5 Asacol 400mg in morning and 4 Asacol 400 in PM, 54-\<90 kg = 6 Asacol 400mg in morning and 6 Asacol 400 in PM
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Warner Chilcottlead
Study Sites (42)
Research Facility
Birmingham, Alabama, 35233, United States
Research Facility
Phoenix, Arizona, 85016, United States
Research Facility
Loma Linda, California, 92354, United States
Research Facility
San Diego, California, 92123, United States
Research Facility
San Francisco, California, 94118, United States
Research Facility
San Francisco, California, 94143, United States
Research Facility
Washington D.C., District of Columbia, 20010, United States
Research Facility
Gainesville, Florida, 32610, United States
Research Facility
Park Ridge, Illinois, 60068, United States
Research Facility
Louisville, Kentucky, 40202, United States
Research Facility
Boston, Massachusetts, 02114, United States
Research Facility
Worcester, Massachusetts, 01655, United States
Research Facility
Kansas City, Missouri, 64108, United States
Research Facility
Omaha, Nebraska, 68015, United States
Research Facility
Mays Landing, New Jersey, 08330, United States
Research Facility
Buffalo, New York, 14222, United States
Research Facility
New Hyde Park, New York, 11040, United States
Research Facility
Youngstown, Ohio, 44514, United States
Research Facility
Portland, Oregon, 97239-3098, United States
Research Facility
Chattanooga, Tennessee, 37404, United States
Research Facility
Knoxville, Tennessee, 37916, United States
Research Facility
Fort Worth, Texas, 76104, United States
Research Facility
Houston, Texas, 77030, United States
Research Facility
San Antonio, Texas, 78229, United States
Research Facility
Norfolk, Virginia, 23507, United States
Research Facility
Huntington, West Virginia, 25701, United States
Research Facility
Halifax, Nova Scotia, B3K 6R8, Canada
Research Facility
Hamilton, Ontario, L8N 3Z5, Canada
Research Facility
London, Ontario, N6A 5W9, Canada
Research Facility
Ottawa, Ontario, K1H 8L1, Canada
Research Facility
Montreal, Quebec, H3T 1C5, Canada
Research Site
Rijeka, Croatia, 51000, Croatia
Research Site
Zagreb, Croatia, 10000, Croatia
Research Site
Bialystok, Poland, 15-274, Poland
Research Site
Bydgoszcz, Poland, 85-094, Poland
Research Site
Krakow, Poland, 30-663, Poland
Research Site
Lodz, Poland, 91-738, Poland
Research Site
Warsazawa, Poland, 04-730, Poland
Research Site
Wroclaw, Poland, 50-369, Poland
Research Site
Bucharest, Romania, 011743, Romania
Research Site
Bucharest, Romania, 041451, Romania
Research Site
Iași, Romania, 700309, Romania
Related Publications (1)
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.
PMID: 25419597DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Grexan Wulff, Manager Regulatory Affairs
- Organization
- Warner Chilcott
Study Officials
- STUDY DIRECTOR
Preston M Dunnmon, MD
Procter and Gamble
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2008
First Posted
July 11, 2008
Study Start
December 1, 2008
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
April 5, 2012
Results First Posted
April 4, 2012
Record last verified: 2012-04