Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea
NCT ID: NCT00310323
Last Updated: 2009-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
69 participants
INTERVENTIONAL
2003-01-31
2006-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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1
Children with OSAS identified via sleep study
Dextromethorphan
0.5 mg/kg (maximum 30 mg)
Caffeine
Administered as 4 ounces of Coca-Cola
Interventions
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Dextromethorphan
0.5 mg/kg (maximum 30 mg)
Caffeine
Administered as 4 ounces of Coca-Cola
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Children who are receiving medications known to induce or inhibit hepatic CYP1A2, NAT-2, XO, CYP2D6 or CYP3A4 activity
* Children who are exposed to second hand smoke for greater than 8 hours per day.
* Children with hypersensitivity to caffeine or dextromethorphan
* Children who are receiving corticosteroids or thyroid hormone
4 Years
16 Years
ALL
No
Sponsors
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University of Louisville
OTHER
Virginia Commonwealth University
OTHER
Responsible Party
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Virginia Commonwealth University
Principal Investigators
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Mary Jayne Kennedy, Pharm.D.
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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University of Louisville
Louisville, Kentucky, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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Other Identifiers
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OSAS 003-03
Identifier Type: -
Identifier Source: org_study_id
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