Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis (CAMPIII)

A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8g/Day) 400 mg Delayed-release Tablets Given Twice Daily for 26 Weeks to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis

The purpose of this study is to determine whether low dose Asacol® (27 mg/kg - 71 mg/kg) and high dose Asacol® (53 mg/kg - 118 mg/kg) are safe and effective when dosed as 400 mg delayed-release tablets given twice daily for 26 weeks to children and adolescents for the maintenance of remission of ulcerative colitis.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2J3
      • Research Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • Research Site
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Research Site
    • London, Ontario, Canada, N6A 5W9
      • Research Site
    • Ottawa, Ontario, Canada, K1H 8L1
      • Research Site
• Croatia
  • Rijeka, Croatia
    • Research Site
  • Zagreb, Croatia
    • Research Site
• Poland
  • Bialystok, Poland, 15-274
    • Research Site
  • Bydgoszcz, Poland, 85-094
    • Research Site
  • Katowice, Poland, 40-752
    • Research Site
  • Krakow, Poland, 30-663
    • Research Site
  • Lodz, Poland, 91-738
    • Research Site
  • Warszawa, Poland, 04-730
    • Research Site
  • Wroclaw, Poland, 50-369
    • Research Site
• Romania
  • Bucharest, Romania, 00 17 43
    • Research Site
  • Bucharest, Romania, 04 14 51
    • Research Site
  • Iasi, Romania, 70 03 09
    • Research Site
• Russian Federation
  • Kazan, Russian Federation, 420138
    • Research Site
  • Moscow, Russian Federation, 105077
    • Research Site
  • Moscow, Russian Federation, 119021
    • Research Site
  • Moscow, Russian Federation, 103001
    • Research Site
  • Moscow, Russian Federation, 117963
    • Research Site
  • Moscow, Russian Federation, 127412
    • Research Site
  • N. Novgorod, Russian Federation, 603950
    • Research Site
  • Novosibirsk, Russian Federation, 630091
    • Research Site
  • Smolensk, Russian Federation, 214019
    • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Research Site
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Research Site
  • California
    • Loma Linda, California, United States, 92354
      • Research Site
    • San Diego, California, United States, 92123
      • Research Site
    • San Francisco, California, United States, 94143
      • Research Site
    • San Francisco, California, United States, 94118
      • Research Site
  • Florida
    • Gainesville, Florida, United States, 32601
      • Research Site
    • Miami, Florida, United States, 33155
      • Research Site
  • Illinois
    • Park Ridge, Illinois, United States, 60068
      • Research Site
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Research Site
  • Maine
    • Portland, Maine, United States, 04102
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Research Site
    • Worcester, Massachusetts, United States, 01655
      • Research Site
  • Michigan
    • Southfield, Michigan, United States, 48075
      • Research Site
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Research Site
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Research Site
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Research Site
  • New Jersey
    • Mays Landing, New Jersey, United States, 08330
      • Research Site
  • New York
    • Buffalo, New York, United States, 14222
      • Research Site
    • New Hyde Park, New York, United States, 11040
      • Research Site
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Research Site
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Research Site
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Research Site
    • San Antonio, Texas, United States, 78229
      • Research Site
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Research Site

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:

• male or female between the ages of 5 and 17 years, inclusive, at the time of the first dose of study medication;
• have a documented history of UC that has been successfully maintained in complete remission for at least 1 month prior to study entry
• have a baseline PUCAI score < 10
• have a body weight no less than 17 kg and no more than 90 kg
• have a history of at least 1 active episode or relapse in the last 12 months
• have taken a stable maintenance dose of oral mesalamine (or equivalent oral 5-ASA dose) for at least 1 month prior to entry in the study. Stable is defined as the same dose for the last month.
• maintained complete remission, as defined, throughout the 30-day run-in phase. Note:ONLY applies to those patients who complete the 6-week treatment in complete remission from Study 2007017 and immediately roll-over to the 30-day run-in phase
• are female patients who are pre-menarchal or have a negative urine pregnancy test and, if sexually active, practice acceptable contraception (e.g., abstinence; oral, intramuscular, or implanted hormonal contraception [at least 3 months prior to enrollment]

Exclusion Criteria:

• 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
• have a history or presence of any condition causing malabsorption or an effect on gastrointestinal motility or history of extensive small bowel resection (greater than one half the length of the small intestine) causing short bowel syndrome
• any "condition" causing "malabsorption" or an effect on gastrointestinal "motility"
• have current renal disease, or a screening blood urea nitrogen (BUN) or creatinine value that is > 1.5 times the upper limit of the age appropriate normal
• have a documented history of or current hepatic disease, or liver function tests (alanine transaminase [ALT], aspartate transaminase [AST], total bilirubin) that are > 2 times the upper limit of normal
• have a history of pancreatitis
• have undergone treatment with any oral, intravenous, intramuscular, or rectally administered corticosteroids (including budesonide) within 30 days prior to the Screening visit
• have undergone treatment with any rectal mesalamine therapy within 30 days prior to the screening visit
• have undergone treatment with immunomodulatory therapy including, but not limited to: rosiglitazone, 6-mercaptopurine or azathioprine, cyclosporine, or methotrexate within 90 days prior to Screening visit
• have undergone treatment with biologic therapy including, but not limited to: infliximab,adalimumab, certolizumab or other biologic treatment of ulcerative colitis within 90 days prior to Screening visit
• have undergone treatment with antibiotics (other than topical antibiotics) including metronidazole within 7 days prior to the Screening visit
• have undergone treatment with aspirin or other nonsteroidal anti-inflammatory drugs NSAIDs) within 7 days prior to the Screening visit
• have undergone treatment with any antidiarrheals and/or antispasmodics within 30 days of the Screening visit
• have a stool examination positive for Clostridium difficile (C. difficile), bacterial pathogens, or ova and parasites. Note: Because normal gut flora may vary by geography, the Medical Monitor should be consulted before excluding a patient with a stool sample that is positive for C. difficile, bacterial pathogens or ova and parasites.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Dose; 2.0 - 4.8 g/day Asacol dependent on body weight	Drug: Asacol 400 mg; 17-33kg = 3 Asacol 400mg AM & 2 Asacol 400mg PM; 33-<54kg = 5 Asacol 400 mg AM & 4 Asacol 400mg PM; 54-<90kg = 6 Asacol 400mg AM & PM; Other Names: mesalamine; 5-aminosalicylic acid; 5-ASA; mesalazine; Drug: Asacol 400 mg; 17-<33kg = 2 Asacol 400mg & 1 placebo AM, 1 Asacol 400mg & 1 placebo PM; 33-<54kg = 3 Asacol 400mg & 2 placebo AM, 2 Asacol 400mg & 2 placebo PM; 54-<90kg = 3 Asacol 400mg & 3 placebo AM & PM; Other Names: mesalamine; 5-aminosalicylic acid; 5-ASA; mesalazine
Experimental: Low Dose; 1.2 - 2.4 g/day Asacol dependent upon body weight	Drug: Asacol 400 mg; 17-33kg = 3 Asacol 400mg AM & 2 Asacol 400mg PM; 33-<54kg = 5 Asacol 400 mg AM & 4 Asacol 400mg PM; 54-<90kg = 6 Asacol 400mg AM & PM; Other Names: mesalamine; 5-aminosalicylic acid; 5-ASA; mesalazine; Drug: Asacol 400 mg; 17-<33kg = 2 Asacol 400mg & 1 placebo AM, 1 Asacol 400mg & 1 placebo PM; 33-<54kg = 3 Asacol 400mg & 2 placebo AM, 2 Asacol 400mg & 2 placebo PM; 54-<90kg = 3 Asacol 400mg & 3 placebo AM & PM; Other Names: mesalamine; 5-aminosalicylic acid; 5-ASA; mesalazine

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 Score (0-85, sum of scores for each): abdominal pain (0/5/10 - no pain/ignored/not ignored), rectal bleeding (0/10/20/30 - none, small amount <50% of stools, small amount most stools, large amount >50%), stool consistency (0/5/10 - formed, partially formed, completely formed), # stools/24 hrs. (0/5/10/15 - 0-2/3-5/6-8/>8), nocturnal bowel/any diarrhea causing wakening (0/10 - no/yes), activity level (0/5/10 - no limitation/occ limitation, severe restrictions). Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85. Remission defined as Treatment Success.	Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT	PUCAI Score (0-85, sum of scores for each) abdominal pain (0/2.5/5/7.5/10 - no pain/very mild/mild/moderate/severe), rectal bleeding (0/10/20/30 - none, small amount <50% of stools, small amount most stools, large amount >50%), stool consistency (0/5/10 - formed, partially formed, completely formed), # stools/24 hrs. (0/5/10/15 - 0-2/3-5/6-8/>8), nocturnal bowel/any diarrhea causing wakening (0/10 - no/yes), activity level (0/5/10 - no limitation/occ limitation, severe restrictions). Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85. Remission is Treatment Success.	Week 26

Collaborators and Investigators

• Sponsor: Warner Chilcott
• Investigators: Study Director: Herman Ellman, MD, Warner Chilcott

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: October 27, 2009
• First Submitted That Met QC Criteria: October 28, 2009
• First Posted (Estimate): October 29, 2009

Study Record Updates

• Last Update Posted (Estimate): May 25, 2012
• Last Update Submitted That Met QC Criteria: April 24, 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; Anti-Infective Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Anti-Bacterial Agents; Antitubercular Agents; Mesalamine; Aminosalicylic Acid
• Other Study ID Numbers: 2008085