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NCT02794844 · ClinicalTrials.gov registry record · Phase 4
Implementation of PPI Medication PGX Testing
A Phase 4 study, sponsored by Nemours Children's Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 28
- Enrollment target
NCT02794844 is a Phase 4 study that has completed, run by Nemours Children's Clinic. The registered enrollment target is 28 participants.
The verdict
NCT02794844, a Phase 4 study, has completed, sponsored by Nemours Children's Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 28 participants
- Enrollment target
Study Summary
Using genetic information about the individual to pick the right drug for the right disease at the right dose defines personalized medicine. This pilot study seeks to institute pharmacogenomic testing, that is identifying genetic variation that influences patient response to drugs, into the Nemours Children's Health system. We propose to initiate the study by identifying genetic differences in cyp2c19, a gene that is responsible for a certain enzyme in the liver that metabolizes many drugs including a class of drugs called proton pump inhibitors (ppi; Prevacid, Nexium). PPIs are used to treat heartburn and other symptoms of gastroesophageal reflux disease (gerd) and are extensively used in pediatrics. Chronic use of PPIs can cause serious side effects including cold, pneumonia and stomach infections, which gets worse at higher doses. Children who poorly metabolize drugs because of genetic variation in cyp2c19 should get lower doses of PPIs than children who metabolize PPIs normally. Our pilot study will genotype children with gerd or other stomach acid mediated conditions for which a PPI is prescribed using a sample of spit to determine which dose of PPI they get based on the form of the cyp2c19 gene they have. We will study 120 children 2-17 yo diagnosed with gastroesophageal reflux disease (gerd) or other stomach acid mediated conditions for which a ppi is prescribed . Genetic results are available in \< 60 minutes, and their doses are determined by their doctor based on genetic results. This study will allow us to gain valuable experience that will be used to expand our genetic program to other genes and drugs.
Interventions
- DRUG Genotype Guided PPI Dosing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2016-07-21 |
| Est. Completion | 2018-08-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02794844
The ClinicalTrials.gov registry entry for NCT02794844 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nemours Children's Clinic, which has 108 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Genotype Guided PPI Dosing is the first listed.
NCT02794844 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02794844 about?
NCT02794844 is a clinical study titled "Implementation of PPI Medication PGX Testing". Using genetic information about the individual to pick the right drug for the right disease at the right dose defines personalized medicine. This pilot study seeks to institute pharmacogenomic testing, that is identifying genetic variation that influences patient response to drugs, into the Nemours ...
What is the current status of trial NCT02794844?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2016-07-21. Estimated completion is 2018-08-31.
What interventions are being tested in trial NCT02794844?
The interventions under investigation include: Genotype Guided PPI Dosing (DRUG).
Who is sponsoring clinical trial NCT02794844?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
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