Hepatic Drug Biotransformation in Children With Obstructi... | NCT00310323

Studies
Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea

NCT00310323

Sponsor

Virginia Commonwealth University

Status

Completed

Last Update Posted

Mar 19, 2009Estimated

Enrollment

69Actual

Phase

Not Applicable

Conditions

Sleep Apnea

Interventions

Dextromethorphan
Caffeine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Feb 2006Actual

Completion Date

Feb 2006Actual

First Submitted Date

Mar 30, 2006

First Submission Date that Met QC Criteria

Mar 30, 2006

First Posted Date

Apr 3, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2009

Last Update Posted Date

Mar 19, 2009Estimated

Name	Class
University of Louisville	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

69Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Children with OSAS identified via sleep study	Drug: Dextromethorphan Drug: Caffeine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dextromethorphan	Drug	0.5 mg/kg (maximum 30 mg)	1
Caffeine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Caffeine urinary molar ratio		Pre and post T&A
Dextromethorphan urinary molar ratio		Pre and post T&A

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mary Jayne Kennedy, Pharm.D.	Virginia Commonwealth University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Louisville		Louisville	Kentucky	40202	United States
Virginia Commonwealth University

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003915	Dextromethorphan
D002110	Caffeine

Ancestor Terms

ID	Term
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided