Implementation of PPI Medication PGX Testing

Completed · Phase 4

Conditions studied: Gastroesophageal Reflux

In brief

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.

Key facts

Study ID

NCT02794844

Run by

Nemours Children's Clinic

People needed

28

Starts

2016-07-21

Expected to finish

2018-08-31

Last updated by the study team

2018-11-21

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children diagnosed with Gastroesophageal Reflux Disease (GERD) or a stomach acid mediated condition for which a PPI is prescribed.
• Currently taking or will be prescribed Proton Pump Inhibitor (PPI) medication
• Parents/legal guardians and or child must also have access to the internet and a valid email address to complete weekly required forms.

You may not qualify if…

• Children who have had peptic ulcer surgery;
• with a history of PKU
• with a history of previous adverse effects from PPI treatment or a sensitivity to aspartame (NutraSweet, Equal);
• who are non-adherent including inability or unwillingness of the legal guardian to provide consent of unwillingness of the child to provide assent;
• who are unable to take study medications;
• who are unable to communicate via telephone or other device;
• who do not have access to a computer with internet access

Where it is running

• Nemours Children's Hospital — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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