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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00713310
• Other study ID #: 2007017
• Status: Completed
• Phase: Phase 3
• First received: July 9, 2008
• Last updated: April 3, 2012
• Start date: December 2008
• Est. completion date: March 2011

Study information

• Verified date: April 2012
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Asacol 400 mg
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
• Asacol 400 mg
Low dose: 17-<33 kg = 2 Asacol 400mg + 1 placebo in morning and 1 Asacol 400 +1 placebo in PM, 33-<54 kg = 3 Asacol 400mg +2 placebo in morning and 2 Asacol 400 + 2 placebo in PM, 54-<90 kg = 3 Asacol 400mg + 3 placebo in morning and 3 Asacol 400mg + 3 placebo in PM

Locations

Country	Name	City	State
Canada	Research Facility	Halifax	Nova Scotia
Canada	Research Facility	Hamilton	Ontario
Canada	Research Facility	London	Ontario
Canada	Research Facility	Montreal	Quebec
Canada	Research Facility	Ottawa	Ontario
Croatia	Research Site	Rijeka
Croatia	Research Site	Zagreb
Poland	Research Site	Bialystok
Poland	Research Site	Bydgoszcz
Poland	Research Site	Krakow
Poland	Research Site	Lodz
Poland	Research Site	Warsazawa
Poland	Research Site	Wroclaw
Romania	Research Site	Bucharest
Romania	Research Site	Bucharest
Romania	Research Site	Iasi
United States	Research Facility	Birmingham	Alabama
United States	Research Facility	Boston	Massachusetts
United States	Research Facility	Buffalo	New York
United States	Research Facility	Chattanooga	Tennessee
United States	Research Facility	Fort Worth	Texas
United States	Research Facility	Gainesville	Florida
United States	Research Facility	Houston	Texas
United States	Research Facility	Huntington	West Virginia
United States	Research Facility	Kansas City	Missouri
United States	Research Facility	Knoxville	Tennessee
United States	Research Facility	Loma Linda	California
United States	Research Facility	Louisville	Kentucky
United States	Research Facility	Mays Landing	New Jersey
United States	Research Facility	New Hyde Park	New York
United States	Research Facility	Norfolk	Virginia
United States	Research Facility	Omaha	Nebraska
United States	Research Facility	Park Ridge	Illinois
United States	Research Facility	Phoenix	Arizona
United States	Research Facility	Portland	Oregon
United States	Research Facility	San Antonio	Texas
United States	Research Facility	San Diego	California
United States	Research Facility	San Francisco	California
United States	Research Facility	San Francisco	California
United States	Research Facility	Washington	District of Columbia
United States	Research Facility	Worcester	Massachusetts
United States	Research Facility	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Countries where clinical trial is conducted

United States,  Canada,  Croatia,  Poland,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT	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)	Baseline and Week 6	Yes