Trial Outcomes & Findings for Implementation of PPI Medication PGX Testing (NCT NCT02794844)

NCT ID: NCT02794844

Last Updated: 2018-11-21

Results Overview

Outcomes for evaluating the success of PGX implementation

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 28 participants
• Primary outcome timeframe: Through 12 months study
• Results posted on: 2018-11-21

Participant Flow

From 06/16/2015 to 02/20/2017, patients (or in the case of children, the pediatric patient and their parent/legal guardian) were approached for participation after a clinical assessment was performed by a GI provider during an outpatient GI appointment. Study procedures were performed after obtaining proper consent and/or child assent.

Participant milestones

Measure	Genotype Guided PPI Dosing Genotype Guided PPI Dosing: PPI type and dosing will be recommended in real time based on patients' CYP2C19 genotype / metabolizer phenotype. No other ARM will be studied.
Overall Study STARTED	28
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Results were inconclusive for 5 participants

Baseline characteristics by cohort

Measure	Genotype Guided PPI Dosing n=28 Participants Genotype Guided PPI Dosing: PPI type and dosing will be recommended in real time based on patients' CYP2C19 genotype / metabolizer phenotype. No other ARM will be studied.
Age, Categorical <=18 years	28 Participants n=28 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=28 Participants
Age, Categorical >=65 years	0 Participants n=28 Participants
Sex: Female, Male Female	13 Participants n=28 Participants
Sex: Female, Male Male	15 Participants n=28 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=28 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=28 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=28 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=28 Participants
Race (NIH/OMB) Asian	2 Participants n=28 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=28 Participants
Race (NIH/OMB) Black or African American	5 Participants n=28 Participants
Race (NIH/OMB) White	16 Participants n=28 Participants
Race (NIH/OMB) More than one race	0 Participants n=28 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=28 Participants
Metabolizer Phenotype Frequency Slow Metabolizers (IM and PM)	5 Participants n=23 Participants • Results were inconclusive for 5 participants
Metabolizer Phenotype Frequency Normal Metabolizers (NM)	11 Participants n=23 Participants • Results were inconclusive for 5 participants
Metabolizer Phenotype Frequency Fast Metabolizers (EM and UM)	7 Participants n=23 Participants • Results were inconclusive for 5 participants

PRIMARY outcome

Timeframe: Through 12 months study

Outcomes for evaluating the success of PGX implementation

Outcome measures

Measure	Genotype Guided PPI Dosing n=28 Participants Genotype Guided PPI Dosing: PI type and dosing will be recommended in real time based on patients' CYP2C19 genotype / metabolizer phenotype. No other ARM will be studied. Genotype Guided PPI Dosing: Dosing of PPIs such as Prevacid and Nexium will be recommended based on CYP2C19 genotype information.
Count of Patients Agreeing to Volunteer for the Study	28 Participants

PRIMARY outcome

Timeframe: Throughout 12 month study

Outcomes for evaluating the success of PGX implementation

Outcome measures

Measure	Genotype Guided PPI Dosing n=28 Participants Genotype Guided PPI Dosing: PI type and dosing will be recommended in real time based on patients' CYP2C19 genotype / metabolizer phenotype. No other ARM will be studied. Genotype Guided PPI Dosing: Dosing of PPIs such as Prevacid and Nexium will be recommended based on CYP2C19 genotype information.
Count of Patients Reporting Efficacy and Toxicity Data	28 Participants

PRIMARY outcome

Timeframe: Throughout 12 month study

Population: 6 providers participated in the study

Outcomes for evaluating the success of PGX implementation

Outcome measures

Measure	Genotype Guided PPI Dosing n=6 Participants Genotype Guided PPI Dosing: PI type and dosing will be recommended in real time based on patients' CYP2C19 genotype / metabolizer phenotype. No other ARM will be studied. Genotype Guided PPI Dosing: Dosing of PPIs such as Prevacid and Nexium will be recommended based on CYP2C19 genotype information.
Count of Providers Agreeing to Participate in Study	6 Participants

PRIMARY outcome

Timeframe: Throughout 12 month study

Outcomes for evaluating the success of PGX implementation

Outcome measures

Measure	Genotype Guided PPI Dosing n=28 Participants Genotype Guided PPI Dosing: PI type and dosing will be recommended in real time based on patients' CYP2C19 genotype / metabolizer phenotype. No other ARM will be studied. Genotype Guided PPI Dosing: Dosing of PPIs such as Prevacid and Nexium will be recommended based on CYP2C19 genotype information.
Count of Participants Agreeing to Future Use of DNA	28 Participants

PRIMARY outcome

Timeframe: Throughout 12 month study

Count of participants reporting adverse effects after genotype-guided PPI therapy.

Outcome measures

Measure	Genotype Guided PPI Dosing n=28 Participants Genotype Guided PPI Dosing: PI type and dosing will be recommended in real time based on patients' CYP2C19 genotype / metabolizer phenotype. No other ARM will be studied. Genotype Guided PPI Dosing: Dosing of PPIs such as Prevacid and Nexium will be recommended based on CYP2C19 genotype information.
Adverse Effects After Genotype-guided PPI Therapy	11 Participants

Adverse Events

Genotype Guided PPI Dosing

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Genotype Guided PPI Dosing n=28 participants at risk Genotype Guided PPI Dosing: PI type and dosing will be recommended in real time based on patients' CYP2C19 genotype / metabolizer phenotype. No other ARM will be studied. Genotype Guided PPI Dosing: Dosing of PPIs such as Prevacid and Nexium will be recommended based on CYP2C19 genotype information.
Gastrointestinal disorders Sore Throat	21.4% 6/28 • Number of events 6 • 12 months
Infections and infestations Cold	25.0% 7/28 • Number of events 7 • 12 months
Infections and infestations Ear Infection	3.6% 1/28 • Number of events 1 • 12 months
Infections and infestations Sinus Infection	7.1% 2/28 • Number of events 2 • 12 months

Additional Information

James P. Franciosi, MD

Nemours Children's Hospital

Phone: 407-567-3832

Email: jfrancio@nemours.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place