CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 185 enrolled
Drug / intervention
CYP2C19 genotypinggenetic
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT02930824N/ACompleted
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Implementing Genomics in Practice (IGNITE) Proof of Concept Study: CYP2C19 Genotype-supported Versus Conventional Proton Pump Inhibitor Dosing

University of Florida·interventional·Posted Oct 12, 2016·Updated May 16, 2024

In Brief

A clinical study evaluating CYP2C19 genotyping for Gastroesophageal Reflux Disease. Completed, enrolled 185 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux Disease
CountriesUnited States
CollaboratorsNemours Children's Hospital, National Human Genome Research Institute (NHGRI)

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedOct 12, 2016
Enrollment StartDec 1, 2016
Primary CompletionJul 17, 2019
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.7 years ago

Interventions

CYP2C19 genotypinggenetic

All proton pump inhibitors are metabolized in part by the CYP2C19 enzyme, which is encoded by the highly polymorphic CYP2C19 gene. Based on variations within this gene the effectiveness of the drug may be reduced.