Study Stopped
Slow enrollment.
A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis.
Study to Determine the Pharmacokinetics of Mesalamine Following Administration of 30, 60, and 90 mg/kg/Day as 400 mg Delayed-release Tablets Given Every 12 Hours for 28 Days to Children/Adolescents With Active Ulcerative Colitis.
1 other identifier
interventional
34
1 country
22
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/kg/day as 400 mg delayed-release tablets given every 12 hours of 28 days to children and adolescents with active ulcerative colitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2005
Typical duration for phase_1
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 14, 2005
CompletedFirst Posted
Study publicly available on registry
November 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedApril 17, 2013
April 1, 2013
2.7 years
November 14, 2005
April 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics
Days 1, 7, 14, 21, and 28
Study Arms (3)
30 mg
EXPERIMENTAL30 mg/kg/day mesalamine
60 mg
EXPERIMENTAL60 mg/kg/day mesalamine
90 mg
EXPERIMENTAL90 mg/kg/day mesalamine
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Warner Chilcottlead
Study Sites (22)
Research Site
Birmingham, Alabama, 35203, United States
Research Site
Mobile, Alabama, 63304, United States
Research Site
Costa Mesa, California, 92626, United States
Research Site
San Diego, California, 92103, United States
Research Site
San Francisco, California, 94143, United States
Research Site
Gainesville, Florida, 32610, United States
Research Site
Jacksonville, Florida, 32207, United States
Research Site
Park Ridge, Illinois, 60068, United States
Research Site
Baltimore, Maryland, 21287, United States
Research Site
Boston, Massachusetts, 21114, United States
Research Site
Detroit, Michigan, 48236, United States
Research Site
Omaha, Nebraska, 68105, United States
Research Site
Morristown, New Jersey, 07962, United States
Research Site
Buffalo, New York, 14222, United States
Research Site
Cincinnati, Ohio, 45229, United States
Research Site
Cleveland, Ohio, 44106, United States
Research Site
Portland, Oregon, 97239, United States
Research Site
Greenville, South Carolina, 29615, United States
Research Site
Dallas, Texas, 75235, United States
Research Site
Houston, Texas, 77030, United States
Research Site
Pasadena, Texas, 77504, United States
Research Site
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
William Aronstein, MD, PhD
Procter and Gamble
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2005
First Posted
November 16, 2005
Study Start
October 1, 2005
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
April 17, 2013
Record last verified: 2013-04