A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis.

Stopped early · Phase 1

Conditions studied: Ulcerative Colitis

In brief

The purpose of this randomized, open-label, parallel-group study is to determine how the body absorbs and eliminates mesalamine following administration of either 30 mg/kg/day, 60 mg/kg/day or 90 mg/kg/day as 400 mg delayed-release tablets given every 12 hours of 28 days to children and adolescents with active ulcerative colitis.

Key facts

Study ID

NCT00254618

Run by

Warner Chilcott

People needed

34

Starts

2005-10-01

Expected to finish

2008-06-01

Last updated by the study team

2013-04-17

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients are eligible to participate in the study if they have/are:
• male or female between the ages of 5 and 17 years, inclusive, at the time of the first dose of study medication
• mildly to moderately active ulcerative colitis (either newly- or previously-diagnosed), as confirmed by their physician, for which mesalamine would be used as part of their normal treatment
• generally in good health (other than the diagnosis of ulcerative colitis), based on medical history, physical examination, and screening laboratory results
• able to swallow Asacol tablets (400 mg marketed US formulation)
• a body weight no less than 16 kg and no more than 90 kg
• able and willing to participate in the study and follow study procedures, as evidenced by providing assent and having a parent/guardian-signed written informed consent.

You may not qualify if…

• Patients will be excluded from the study if they have/are:
• a history of cancer 2. a history of intestinal surgery or malabsorption 3. a history of renal insufficiency 4 a history of allergy or hypersensitivity to salicylates or aminosalicylates 5. evidence of clinically significant organic or psychiatric disease on medical history or physical examination that, in the Investigator's opinion, would prevent the patient from completing the study or would jeopardize the patient's safety 6. a creatinine clearance of < or =30 mL/minute at screening, estimated by serum creatinine using the Traub \& Johnson equation for calculating pediatric creatinine clearance.
• a screening BUN or creatinine value that is >1.5 times the upper limit of normal, or liver function tests that are >2 times the upper limit of normal 8. any other screening laboratory test values that the Investigator or Sponsor considers clinically significant that would impact the outcome of the study or the safety of the patient 9. using proton pump inhibitors or antacids 10. pregnant (post-menarchal female patients should be made aware that pregnancy testing will occur during the study, and that if they are sexually active they must take appropriate steps to ensure they do not become pregnant during the study) 11. a positive urine screen for drugs of abuse 12. participated in another clinical trial involving active intervention within 30 days prior to randomization.

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — Mobile, Alabama, United States
• Research Site — Costa Mesa, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Gainesville, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Park Ridge, Illinois, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Omaha, Nebraska, United States
• Research Site — Morristown, New Jersey, United States
• Research Site — Buffalo, New York, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Portland, Oregon, United States
• Research Site — Greenville, South Carolina, United States
• Research Site — Dallas, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — Pasadena, Texas, United States
• Research Site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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