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

Phase 3

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: Asacol 400 mg

• Registration Number: NCT00713310
• Lead Sponsor: Warner Chilcott

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-09
• Study First Submitted QC: 2008-07-10
• Study First Posted: 2008-07-11
• Study Start: 2008-12
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2012-03-06
• Results First Submitted QC: 2012-03-06
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-03
• Results First Posted: 2012-04-04
• Last Update Posted: 2012-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-Dose	Asacol 400 mg	1.2 - 2.4 g/day Asacol dependent on body weight
High-Dose	Asacol 400 mg	2.0 - 4.8 g/day Asacol dependent on body weight

Primary Outcome Measures

Name	Time	Method
Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population	Baseline and 6 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT	Baseline and Week 6	PUCAI 0-85, abdominal pain amended (no pain/0, very mild/2.5, mild/5, moderate/7.5, severe/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)

Trial Locations

Locations (2)

Research Site; 🇷🇴 Iasi, Romania

Research Facility; 🇨🇦 Montreal, Quebec, Canada