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Genotype-supported Versus Conventional Proton Pump Inhibitor Dosing

NCT02930824 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2024-05-16

Study results available
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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.

Conditions

  • Gastroesophageal Reflux Disease

Interventions

GENETIC

CYP2C19 genotyping

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.

Sponsors & Collaborators

  • Nemours Children's Hospital

    collaborator OTHER

  • National Human Genome Research Institute (NHGRI)

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • Larisa Cavallari, PharmD · University of Florida

  • James P Franciosi, MD · Nemours Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2019-07-17
Completion
2019-07-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02930824 on ClinicalTrials.gov