Status:
TERMINATED
A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis.
Lead Sponsor:
Warner Chilcott
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
5-17 years
Phase:
PHASE1
Brief Summary
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/k...
Detailed Description
Ulcerative colitis is a type of inflammatory bowel disease characterized by diffuse, continuous inflammation of the colon. Recent estimates suggest that approximately 17,000 children between 5 and 17 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patients will be excluded from the study if they have/are:
- 1\. 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.
- 7\. 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.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00254618
Start Date
October 1 2005
End Date
June 1 2008
Last Update
April 17 2013
Active Locations (22)
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1
Research Site
Birmingham, Alabama, United States, 35203
2
Research Site
Mobile, Alabama, United States, 63304
3
Research Site
Costa Mesa, California, United States, 92626
4
Research Site
San Diego, California, United States, 92103