Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea - Full Text View

Sponsors and Collaborators:	Virginia Commonwealth University University of Louisville
Information provided by:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00310323

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

MedlinePlus related topics: Caffeine Sleep Apnea

Drug Information available for: Dextromethorphan hydrochloride Levomethorphan Dextromethorphan Racemethorphan Dextromethorphan hydrobromide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Effect of Chronic Intermittent Nocturnal Hypoxia on Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea

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

Keywords provided by Virginia Commonwealth University:

sleep apnea
phenotyping
cytochrome P450
drug metabolism
child

Study placed in the following topic categories:

Caffeine citrate
Excitatory Amino Acids
Neurotransmitter Agents
Sleep Apnea Syndromes
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Sleep Disorders
Dyssomnias

Sleep Disorders, Intrinsic
Naphazoline
Signs and Symptoms
Respiratory Tract Diseases
Guaifenesin
Dextromethorphan
Signs and Symptoms, Respiratory
Caffeine
Phenylpropanolamine

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Sleep Apnea Syndromes
Molecular Mechanisms of Pharmacological Action
Apnea
Physiological Effects of Drugs
Sleep Apnea, Obstructive
Respiration Disorders
Nervous System Diseases
Dyssomnias
Sleep Disorders

Excitatory Amino Acid Agents
Pharmacologic Actions
Sleep Disorders, Intrinsic
Signs and Symptoms
Respiratory Tract Diseases
Therapeutic Uses
Dextromethorphan
Signs and Symptoms, Respiratory
Antitussive Agents
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on May 07, 2009