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Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Collaborator:
University of Louisville
Information provided by:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00310323
First received: March 30, 2006
Last updated: March 17, 2009
Last verified: March 2009
History of Changes
  Purpose

The purpose of this research study is to determine the effect of chronic nighttime low oxygen saturations on selected body systems (liver) that break down drugs in children with obstructive sleep apnea syndrome (OSAS).


Condition Intervention
Sleep Apnea
 Drug: Dextromethorphan
Drug: Caffeine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Effect of Chronic Intermittent Nocturnal Hypoxia on Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Caffeine urinary molar ratio [ Time Frame: Pre and post T&A ] [ Designated as safety issue: No ]
  • Dextromethorphan urinary molar ratio [ Time Frame: Pre and post T&A ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: January 2003
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Children with OSAS identified via sleep study
 Drug: Dextromethorphan
0.5 mg/kg (maximum 30 mg)
Drug: Caffeine
Administered as 4 ounces of Coca-Cola

Detailed Description:

The purpose of this study is to determine the effect of chronic intermittent nocturnal hypoxia on selected hepatic drug-metabolizing enzyme systems in children with OSAS. The specific aims are to evaluate the activities of cytochrome P450 (CYP)1A2, N-acetyltransferase-2 (NAT-2), xanthine oxidase (XO)and CYP2D6 in children with OSAS and to determine the effect of OSAS treatment on the activities of these enzyme systems.

  Eligibility

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children ages 4 to 16 years with suspected uncomplicated OSAS

Exclusion Criteria:

  • Children with complicated OSAS (craniofacial abnormalities, neuromuscular disorders)
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310323

Locations
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
University of Louisville
Investigators
Principal Investigator: Mary Jayne Kennedy, Pharm.D. Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Mary Jayne Kennedy, Pharm.D., Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00310323     History of Changes
Other Study ID Numbers: OSAS 003-03
Study First Received: March 30, 2006
Last Updated: March 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
sleep apnea
phenotyping
cytochrome P450
drug metabolism
child

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Caffeine
Dextromethorphan
Central Nervous System Stimulants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 19, 2013