NCT00310323

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2003

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 3, 2006

Completed
Last Updated

March 19, 2009

Status Verified

March 1, 2009

Enrollment Period

3.1 years

First QC Date

March 30, 2006

Last Update Submit

March 17, 2009

Conditions

Sleep Apnea

Keywords

sleep apneaphenotypingcytochrome P450drug metabolismchild

Outcome Measures

Primary Outcomes (2)

  • Caffeine urinary molar ratio

    Pre and post T&A

  • Dextromethorphan urinary molar ratio

    Pre and post T&A

Study Arms (1)

1

EXPERIMENTAL

Children with OSAS identified via sleep study

Drug: DextromethorphanDrug: Caffeine

Interventions

DextromethorphanDRUG

0.5 mg/kg (maximum 30 mg)

1
CaffeineDRUG

Administered as 4 ounces of Coca-Cola

1

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children ages 4 to 16 years with suspected uncomplicated OSAS

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

DextromethorphanCaffeine

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsXanthinesPurinonesPurinesHeterocyclic Compounds, 2-Ring

Study Officials

  • Mary Jayne Kennedy, Pharm.D.

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 30, 2006

First Posted

April 3, 2006

Study Start

January 1, 2003

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

March 19, 2009

Record last verified: 2009-03

Locations

US(2)