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

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Asacol 400 mg; Drug: Asacol 400 mg

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • Research Facility
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Research Facility
    • London, Ontario, Canada, N6A 5W9
      • Research Facility
    • Ottawa, Ontario, Canada, K1H 8L1
      • Research Facility
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • Research Facility
• Croatia
  • Rijeka, Croatia, 51000
    • Research Site
  • Zagreb, Croatia, 10000
    • Research Site
• Poland
  • 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
    • Research Site
• Romania
  • Bucharest, Romania, 011743
    • Research Site
  • Bucharest, Romania, 041451
    • Research Site
  • Iasi, Romania, 700309
    • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Research Facility
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Research Facility
  • California
    • Loma Linda, California, United States, 92354
      • Research Facility
    • San Diego, California, United States, 92123
      • Research Facility
    • San Francisco, California, United States, 94143
      • Research Facility
    • San Francisco, California, United States, 94118
      • Research Facility
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Research Facility
  • Florida
    • Gainesville, Florida, United States, 32610
      • Research Facility
  • Illinois
    • Park Ridge, Illinois, United States, 60068
      • Research Facility
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Research Facility
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Research Facility
    • Worcester, Massachusetts, United States, 01655
      • Research Facility
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Research Facility
  • Nebraska
    • Omaha, Nebraska, United States, 68015
      • Research Facility
  • New Jersey
    • Mays Landing, New Jersey, United States, 08330
      • Research Facility
  • New York
    • Buffalo, New York, United States, 14222
      • Research Facility
    • New Hyde Park, New York, United States, 11040
      • Research Facility
  • Ohio
    • Youngstown, Ohio, United States, 44514
      • Research Facility
  • Oregon
    • Portland, Oregon, United States, 97239-3098
      • Research Facility
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Research Facility
    • Knoxville, Tennessee, United States, 37916
      • Research Facility
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Research Facility
    • Houston, Texas, United States, 77030
      • Research Facility
    • San Antonio, Texas, United States, 78229
      • Research Facility
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Research Facility
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Research Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-Dose; 1.2 - 2.4 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; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Warner Chilcott
• Investigators: Study Director: Preston M Dunnmon, MD, Procter and Gamble

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: July 9, 2008
• First Submitted That Met QC Criteria: July 10, 2008
• First Posted (Estimate): July 11, 2008

Study Record Updates

• Last Update Posted (Estimate): April 5, 2012
• Last Update Submitted That Met QC Criteria: April 3, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Mesalamine
• Other Study ID Numbers: 2007017