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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00713310
First received: July 9, 2008
Last updated: April 3, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
Drug: Asacol 400 mg
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: Yes ]
    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:
  • Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: Yes ]
    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)


Enrollment: 83
Study Start Date: December 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low-Dose
1.2 - 2.4 g/day Asacol dependent on body weight
Drug: 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

Experimental: High-Dose
2.0 - 4.8 g/day Asacol dependent on body weight
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


  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713310

  Hide Study Locations
Locations
United States, Alabama
Research Facility
Birmingham, Alabama, United States, 35233
United States, Arizona
Research Facility
Phoenix, Arizona, United States, 85016
United States, California
Research Facility
Loma Linda, California, United States, 92354
Research Facility
San Diego, California, United States, 92123
Research Facility
San Francisco, California, United States, 94118
Research Facility
San Francisco, California, United States, 94143
United States, District of Columbia
Research Facility
Washington, District of Columbia, United States, 20010
United States, Florida
Research Facility
Gainesville, Florida, United States, 32610
United States, Illinois
Research Facility
Park Ridge, Illinois, United States, 60068
United States, Kentucky
Research Facility
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Research Facility
Boston, Massachusetts, United States, 02114
Research Facility
Worcester, Massachusetts, United States, 01655
United States, Missouri
Research Facility
Kansas City, Missouri, United States, 64108
United States, Nebraska
Research Facility
Omaha, Nebraska, United States, 68015
United States, New Jersey
Research Facility
Mays Landing, New Jersey, United States, 08330
United States, New York
Research Facility
Buffalo, New York, United States, 14222
Research Facility
New Hyde Park, New York, United States, 11040
United States, Ohio
Research Facility
Youngstown, Ohio, United States, 44514
United States, Oregon
Research Facility
Portland, Oregon, United States, 97239-3098
United States, Tennessee
Research Facility
Chattanooga, Tennessee, United States, 37404
Research Facility
Knoxville, Tennessee, United States, 37916
United States, Texas
Research Facility
Fort Worth, Texas, United States, 76104
Research Facility
Houston, Texas, United States, 77030
Research Facility
San Antonio, Texas, United States, 78229
United States, Virginia
Research Facility
Norfolk, Virginia, United States, 23507
United States, West Virginia
Research Facility
Huntington, West Virginia, United States, 25701
Canada, Nova Scotia
Research Facility
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
Research Facility
Hamilton, Ontario, Canada, L8N 3Z5
Research Facility
London, Ontario, Canada, N6A 5W9
Research Facility
Ottawa, Ontario, Canada, K1H 8L1
Canada, Quebec
Research Facility
Montreal, Quebec, Canada, H3T 1C5
Croatia
Research Site
Rijeka, Croatia, 51000
Research Site
Zagreb, Croatia, 10000
Poland
Research Site
Bialystok, Poland, 15-274
Research Site
Bydgoszcz, Poland, 85-094
Research Site
Krakow, Poland, 30-663
Research Site
Lodz, Poland, 91-738
Research Site
Warsazawa, Poland, 04-730
Research Site
Wroclaw, Poland, 50-369
Romania
Research Site
Bucharest, Romania, 041451
Research Site
Bucharest, Romania, 011743
Research Site
Iasi, Romania, 700309
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Preston M Dunnmon, MD Procter and Gamble
  More Information

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00713310     History of Changes
Other Study ID Numbers: 2007017
Study First Received: July 9, 2008
Results First Received: March 6, 2012
Last Updated: April 3, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014