Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Implementation of PPI Medication PGX Testing (PGX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794844
Recruitment Status : Completed
First Posted : June 9, 2016
Results First Posted : May 9, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
James Franciosi, Nemours Children's Clinic

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gastroesophageal Reflux
Intervention Drug: Genotype Guided PPI Dosing
Enrollment 28
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Genotype Guided PPI Dosing
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 28
Completed 23
Not Completed 5
Arm/Group Title Genotype Guided PPI Dosing
Hide Arm/Group Description

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 Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
<=18 years
28
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
13
  46.4%
Male
15
  53.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Hispanic or Latino
17
  60.7%
Not Hispanic or Latino
11
  39.3%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   7.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  17.9%
White
16
  57.1%
More than one race
0
   0.0%
Unknown or Not Reported
5
  17.9%
Metabolizer Phenotype Frequency   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Slow Metabolizers (IM and PM)
5
  21.7%
Normal Metabolizers (NM)
11
  47.8%
Fast Metabolizers (EM and UM)
7
  30.4%
[1]
Measure Description:

Depending on the CYP2C19 genotype individuals are classified into different phenotypes: poor metabolizer (PM), intermediate metabolizers (IM), normal metabolizers (NM), rapid metabolizer (RM) and ultra-rapid metabolizers (UM).

Allele Genotype/Activity Phenotype

  • 1/*1 -2 active alleles NM
  • 1/n -1 active, 1 LOF allele IM
  • 2/*2 or *n*n -2 LOF alleles PM
  • 1/*17 -1 active, 1 GOF allele RM
  • 17/*17 -2 GOF alleles UM
[2]
Measure Analysis Population Description: Results were inconclusive for 5 participants
1.Primary Outcome
Title Count of Patients Agreeing to Volunteer for the Study
Hide Description Outcomes for evaluating the success of PGX implementation
Time Frame Through 12 months study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Genotype Guided PPI Dosing
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 28
Measure Type: Count of Participants
Unit of Measure: Participants
28
 100.0%
2.Primary Outcome
Title Count of Patients Reporting Efficacy and Toxicity Data
Hide Description Outcomes for evaluating the success of PGX implementation
Time Frame Throughout 12 month study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Genotype Guided PPI Dosing
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 28
Measure Type: Count of Participants
Unit of Measure: Participants
28
 100.0%
3.Primary Outcome
Title Count of Providers Agreeing to Participate in Study
Hide Description Outcomes for evaluating the success of PGX implementation
Time Frame Throughout 12 month study
Hide Outcome Measure Data
Hide Analysis Population Description
6 providers participated in the study
Arm/Group Title Genotype Guided PPI Dosing
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
6
 100.0%
4.Primary Outcome
Title Count of Participants Agreeing to Future Use of DNA
Hide Description Outcomes for evaluating the success of PGX implementation
Time Frame Throughout 12 month study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Genotype Guided PPI Dosing
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 28
Measure Type: Count of Participants
Unit of Measure: Participants
28
 100.0%
5.Primary Outcome
Title Adverse Effects After Genotype-guided PPI Therapy
Hide Description Count of participants reporting adverse effects after genotype-guided PPI therapy.
Time Frame Throughout 12 month study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Genotype Guided PPI Dosing
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 28
Measure Type: Count of Participants
Unit of Measure: Participants
11
  39.3%
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Genotype Guided PPI Dosing
Hide Arm/Group Description

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.

All-Cause Mortality
Genotype Guided PPI Dosing
Affected / at Risk (%)
Total   0/28 (0.00%)    
Hide Serious Adverse Events
Genotype Guided PPI Dosing
Affected / at Risk (%) # Events
Total   0/28 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Genotype Guided PPI Dosing
Affected / at Risk (%) # Events
Total   11/28 (39.29%)    
Gastrointestinal disorders   
Sore Throat   6/28 (21.43%)  6
Infections and infestations   
Cold   7/28 (25.00%)  7
Ear Infection   1/28 (3.57%)  1
Sinus Infection   2/28 (7.14%)  2
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: James P. Franciosi, MD
Organization: Nemours Children's Hospital
Phone: 407-567-3832
EMail: jfrancio@nemours.org
Layout table for additonal information
Responsible Party: James Franciosi, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT02794844    
Other Study ID Numbers: 744230
First Submitted: April 27, 2016
First Posted: June 9, 2016
Results First Submitted: April 9, 2018
Results First Posted: May 9, 2018
Last Update Posted: November 21, 2018