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

Ulcerative Colitis Clinical Trial

— CAMPIII  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01004185
• Other study ID #: 2008085
• Status: Terminated
• Phase: Phase 3
• First received: October 27, 2009
• Last updated: April 24, 2012
• Start date: October 2009
• 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• 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:

• 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 Design

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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
• 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

Locations

Country	Name	City	State
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	London	Ontario
Canada	Research Site	Ottawa	Ontario
Croatia	Research Site	Rijeka
Croatia	Research Site	Zagreb
Poland	Research Site	Bialystok
Poland	Research Site	Bydgoszcz
Poland	Research Site	Katowice
Poland	Research Site	Krakow
Poland	Research Site	Lodz
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
Romania	Research Site	Bucharest
Romania	Research Site	Bucharest
Romania	Research Site	Iasi
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	N. Novgorod
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Smolensk
United States	Research Site	Birmingham	Alabama
United States	Research Site	Boston	Massachusetts
United States	Research Site	Buffalo	New York
United States	Research Site	Fort Worth	Texas
United States	Research Site	Gainesville	Florida
United States	Research Site	Huntington	West Virginia
United States	Research Site	Jackson	Mississippi
United States	Research Site	Kansas City	Missouri
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Loma Linda	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Mays Landing	New Jersey
United States	Research Site	Miami	Florida
United States	Research Site	Nashville	Tennessee
United States	Research Site	New Hyde Park	New York
United States	Research Site	Park Ridge	Illinois
United States	Research Site	Phoenix	Arizona
United States	Research Site	Portland	Maine
United States	Research Site	Providence	Rhode Island
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	San Francisco	California
United States	Research Site	San Francisco	California
United States	Research Site	Southfield	Michigan
United States	Research Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Countries where clinical trial is conducted

United States,  Canada,  Croatia,  Poland,  Romania,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No