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
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux||Drug: Genotype Guided PPI Dosing||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Implementation of Pharmacogenomic Testing in Nemours Children's Health System|
|Actual Study Start Date :||July 21, 2016|
|Actual Primary Completion Date :||January 23, 2017|
|Actual Study Completion Date :||August 31, 2018|
Experimental: Genotype Guided PPI Dosing
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.
Drug: 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 [ Time Frame: Through 12 months study ]Outcomes for evaluating the success of PGX implementation
- Count of Patients Reporting Efficacy and Toxicity Data [ Time Frame: Throughout 12 month study ]Outcomes for evaluating the success of PGX implementation
- Count of Providers Agreeing to Participate in Study [ Time Frame: Throughout 12 month study ]Outcomes for evaluating the success of PGX implementation
- Count of Participants Agreeing to Future Use of DNA [ Time Frame: Throughout 12 month study ]Outcomes for evaluating the success of PGX implementation
- Adverse Effects After Genotype-guided PPI Therapy [ Time Frame: Throughout 12 month study ]Count of participants reporting adverse effects after genotype-guided PPI therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794844
|United States, Florida|
|Nemours Children's Hospital|
|Orlando, Florida, United States, 32827|
|Principal Investigator:||James P Franciosi, MD||Nemours Children's Hospital|