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Not yet recruitingNCT07843264Updated Sep 28, 2026

PPI Dosing Per CYP2C19 Genotype

A Phase 4 interventional study of CYP2C19 based dosing Proton Pump Inhibitors and Conventional proton pump inhibitor dose in Gastroesophageal Reflux Disease With Esophagitis, sponsored by University of Florida. Not yet recruiting. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by University of Florida · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

This study is being done to determine if the dosing of proton pump inhibitor (PPI) medication based on CYP2C19 genotype-derived phenotype leads to improved healing of erosive esophagitis compared to conventional PPI medication dosing.

02

Conditions studied

  • Gastroesophageal Reflux Disease With Esophagitis

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03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • age ≥ 18 years
  • diagnosis of Gastroesophageal Reflux Disease (GERD) scheduled for an esophagogastroduodenoscopy (EGD)
  • patients diagnosed with Erosive Esophagitis on endoscopy (EGD).

Exclusion criteria

Exclusion Criteria:

  • age \<18 years
  • diagnosed with non-erosive reflux disease (NERD)
  • pregnancy
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Intervention

    proton pump inhibitor dose based on CYP2C19 phenotypes

    Drug: CYP2C19 based dosing Proton Pump Inhibitors

  • Active comparator
    Control

    conventional proton pump inhibitor dose of Pantoprazole 40 mg once or twice daily

    Drug: Conventional proton pump inhibitor dose

Interventions

  • DrugCYP2C19 based dosing Proton Pump Inhibitors

    Pantoprazole dosing based on CYP2C19 phenotypes

  • DrugConventional proton pump inhibitor dose

    conventional PPI dose of Pantoprazole 40 mg once or twice daily

05

What researchers measure

Primary outcomes

  1. Improvement of Los Angeles (LA) classification of Erosive Esphagitis (EE) grade

    Assessment of erosive esophagitis grade to determine healing in both arms. Healing would be measured by endoscopic regression of errosive esophagitis (EE) to a lower degree of inflammation. Previously assigned baseline numerical values per the LA classification of EE will be used to calculate the degree of healing in each arm at the 8th week follow up, e.g. LA grade D (initial EGD) to LA grade A (repeat EGD) would yield a score of 3 (LA D \[5\] - LA A \[2\]). A higher score hence indicating superior healing of EE.

    Time frame: 8 weeks

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07843264
Lead sponsor
University of Florida
Responsible party
Sponsor
First posted
Sep 28, 2026
Start date
Oct 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Apr 1, 2028 (estimated)
Last update
Sep 28, 2026

Study contacts

Ruchir Puri, MD
principal investigator · University of Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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