Ignite Creation Date:
2024-05-06 @ 9:14 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02930824
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2016-10-10
Brief Title:
Genotype-supported Versus Conventional Proton Pump Inhibitor Dosing
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Implementing Genomics in Practice IGNITE Proof of Concept Study CYP2C19 Genotype-supported Versus Conventional Proton Pump Inhibitor Dosing
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Investigators will conduct a comparative effectiveness study of genotype-supported vs conventional PPI dosing Adults and children presenting with Gastroesophageal Reflux Disease GERD or dyspepsia symptoms and either 1 being initiated on proton pump inhibitor PPI therapy or 2 with continued symptoms on current PPI therapy will be recruited from gastroenterology clinics and randomized to a genotype-supported versus conventional PPI therapy management strategy
Detailed Description:
The efficacy of proton pump inhibitors PPIs is highly dependent on plasma concentrations achieved following drug administration All PPIs are metabolized in part by the CYP2C19 enzyme which is encoded by the highly polymorphic CYP2C19 gene Depending on the CYP2C19 genotype individuals are classified into different metabolizer phenotypes poor metabolizers PM 2 loss-of-function CYP2C19 alleles intermediate metabolizers IM one loss-of-function allele normal metabolizers NM no loss or gain-of-function alleles rapid metabolizer RM one gain-of-function allele and ultra-rapid metabolizers UM two gain-of function-alleles Genetic variants in CYP2C19 are known to profoundly influence PPI plasma concentrations and consequently response to PPI therapy For example individuals classified as either RM or UM have lower PPI concentrations compared to NM or loss-of-function LOF allele carriers respond poorly to PPI therapy and some fail to respond even when the PPI dose is increased The investigators hypothesize that genotype-supported PPI dosing will lead to better GERD control and improvement in severity of dyspepsia symptoms compared to conventional dosing The investigators will conduct a comparative effectiveness study of genotype-supported vs conventional PPI dosing Patients presenting with GERD or dyspepsia symptoms and either 1 being initiated on PPI therapy or 2 with continued symptoms on current PPI therapy will be recruited from gastroenterology clinics and randomized to a genotype-supported versus conventional PPI therapy management strategy The investigators will integrate individual CYP2C19 genotype information into dosing decisions for the genotype-supported arm and compare change in symptom control from baseline to the end of the study between study arms Given that PPI efficacy is related to PPI exposure and to metabolizer phenotype individualizing treatment using CYP2C19 genotype-supported dosing is expected to improve symptom management The investigators will also evaluate patient and clinician knowledge and attitudes about pharmacogenetics testing and physician acceptance of genetic information into clinical practice Finally the investigators will collect preliminary data on the potential impact of CYP2C19-supported PPI dosing on adverse event rates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HG007269 | NIH | None | httpsreporternihgovquickSearchU01HG007269 |