Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00713310
• Date of registration: 09/07/2008
• Prospective Registration: Yes
• Primary sponsor: Warner Chilcott
• Public title: Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis
• Scientific 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
• Date of first enrolment: December 2008
• Target sample size: 83
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00713310
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Canada, Croatia, Poland, Romania, United States

Contacts

• Name: Preston M Dunnmon, MD
• Affiliation: Procter and Gamble

Key inclusion & exclusion 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



Age minimum: 5 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Asacol 400 mg

Primary Outcome(s)

Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population [Time Frame: Baseline and 6 weeks]

Secondary Outcome(s)

Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT [Time Frame: Baseline and Week 6]

Secondary ID(s)

2007017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/04/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00713310