Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea

Sleep Apnea Clinical Trial

Official title:

Effect of Chronic Intermittent Nocturnal Hypoxia on Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310323
• Other study ID #: OSAS 003-03
• Status: Completed
• Phase: N/A
• First received: March 30, 2006
• Last updated: March 17, 2009
• Start date: January 2003
• Est. completion date: February 2006

Study information

• Verified date: March 2009
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 16 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Dextromethorphan
0.5 mg/kg (maximum 30 mg)
• Caffeine
Administered as 4 ounces of Coca-Cola

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caffeine urinary molar ratio		Pre and post T&A	No
Primary	Dextromethorphan urinary molar ratio		Pre and post T&A	No