Who is sponsoring NCT00117715?

NCT00117715 is sponsored by Children's Mercy Hospital Kansas City.

What drugs are being tested in NCT00117715?

Interventions in NCT00117715: Genotyping and Phenotyping using dextromethorphan and caffeine as probes.

Is NCT00117715 still recruiting?

NCT00117715 is currently completed. Last updated 11 August 2017.

Are results published for NCT00117715?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-08-11 · How we verify

NCT00117715

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Developmental Regulation of CYPs 1A2, 2D6, 3A4

Completed Results posted Last updated 11 August 2017

What this trial tests

trial testing Genotyping and Phenotyping using dextromethorphan and caffeine as probes in Healthy in 121 participants. Completed in 1 January 2010.

Timeline

1 October 2000

Primary endpoint
1 January 2010

1 January 2010

Quick facts

Lead sponsor	Children's Mercy Hospital Kansas City
Status	Completed
Study type	OBSERVATIONAL
Enrollment	121
Start date	1 October 2000
Primary completion	1 January 2010
Estimated completion	1 January 2010
Sites	1 location across United States

Drugs / interventions tested

Genotyping and Phenotyping using dextromethorphan and caffeine as probes

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Children's Mercy Hospital Kansas City

Who can join

Adults 12 Months to 5, any sex, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change in CYP2D6 Drug Metabolism Phenotype With Age
Time frame: every 6 months for 5 years
Concentrations of dextromethorphan(DM) and it's metabolite dextrorphan (DX) are quantified in urine and used to estimate the activity of cytochromes P450 2D6 using the well established DM/DX ratio. The longitudinal study design allows for changes in drug metabolism activity as a function of age which can be characterized via least squares regression where the slope of age vs. DM/DX ratio is examin
Change in CYP3A4 Drug Metabolism Phenotype With Age
Time frame: every 6 months for 5 years
Concentrations of dextromethorphan (DM) metabolites 3-hydroxymorphinan (3HM) and dextrorphan (DX) are quantified in urine and used to estimate the activity of cytochrome P450 3A4 using the well established 3HM/DX ratio. The longitudinal study design allows for changes in drug metabolism activity as a function of age which can be characterized via least squares regression where the slope of age vs.
Change in CYP1A2 Drug Metabolism Phenotype With Age
Time frame: every 6 months for 5 years
Concentrations of caffeine metabolites 5-Acetylamino-6-amino-3-methyluracil (AAMU), 1-methylxanthine (1MX), 1-methyluric acid (1MU), and 1,7-dimethyluric acid (17MU) are quantified in urine and used to estimate the activity of cytochrome P450 1A2 using the well established (AAMU+1MX+1MU)/1,7U ratio. The longitudinal study design allows for changes in drug metabolism activity as a function of age w

Sponsor's own description

This is a drug metabolism study in one-year old children involving caffeine and dextromethorphan.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00117715 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Children's Mercy Hospital Kansas City
Last refreshed: 11 August 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00117715.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing