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NCT01118858 · ClinicalTrials.gov registry record
Biomarkers of CYP2D6 and CYP3A4 Variability in Pediatrics
A clinical trial, sponsored by Children's Mercy Hospital Kansas City.
- Completed
- Registry status
- 205
- Enrollment target
NCT01118858: Completed study, sponsored by Children's Mercy Hospital Kansas City.
NCT01118858 is a clinical trial that has completed, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 205 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01118858 has completed, sponsored by Children's Mercy Hospital Kansas City.
- COMPLETED
- Registry status
- 205 participants
- Enrollment target
Study Summary
Cytochrome P450 2D6 (CYP2D6) is an important enzyme in the body for breaking down many medications that are commonly used in children of various ages. The purpose of this proposal is to investigate the relative roles of development and genetic variation in CYP2D6 activity in school-aged children and adolescents with attention deficit and hyperactivity disorder and health controls using the over-the-counter cough suppressant, dextromethorphan or "DM", a standard probe for determining CYP2D6 phenotype. Embedded in the study design are sub-studies to search for by-products of normal body metabolism that reflect differences in enzyme activity, and a pharmacokinetic study to assess the consequences of CYP2D6 genetic variation on the systemic exposure to medications used by this patient population. Ultimately, the goal of the research is to personalize the use of medications in children by selecting the appropriate dose of the correct medication for individual patients.
Primary Outcome
Growth and development adds an additional level of complexity as the genotype-phenotype relationship may change as children grow and develop. The purpose of this proposal is to characterize the relative roles of ontogeny and genetic variation towards changes in CYP2D6 and CYP3A4 activity during adolescence. Because some drugs commonly used to treat ADHD are metabolized by CYP2D6 and CYP3A4, the information gained from this study will contribute to a better understanding of the dosage requirement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 205 participants |
| Start Date | 2010-04 |
| Est. Completion | 2015-10 |
What the finished NCT01118858 record still lists
NCT01118858 is an observational study that tracks outcomes without assigning an intervention. The registered 205 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01118858 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01118858 about?
NCT01118858 is a clinical study titled "Biomarkers of CYP2D6 and CYP3A4 Variability in Pediatrics". Cytochrome P450 2D6 (CYP2D6) is an important enzyme in the body for breaking down many medications that are commonly used in children of various ages. The purpose of this proposal is to investigate the relative roles of development and genetic variation in CYP2D6 activity in school-aged children and...
What is the current status of trial NCT01118858?
This trial is currently completed. The enrollment target is 205 participants. The study started on 2010-04. Estimated completion is 2015-10.
Who is sponsoring clinical trial NCT01118858?
This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.
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