ClinicalTrials.gg
RecruitingNCT07843264Updated Nov 12, 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. Recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.

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

Updated Nov 12, 2026Now RecruitingFirst site in United States+3 moreGo to Updates ↓

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

Where this study stands

Counted across the records on this site · 2026-11-14

Among 15 studies in Esophagitis, Peptic with a site in United States — 2 open to participants now, 2 under way, none of them phase 3. Esophagitis, Peptic · United States.

Planned enrollment
7th of 14
200 · median 180
Started
2026
the only one that year
Phase 4
3 of 15
1 open now
Registered
15th of 15
by date
Lead sponsor
1 of 15
University of Florida

Among the 15 studies in Esophagitis, Peptic with a site in United States, this one is the 7th largest by planned enrollment of the 14 interventional ones that give a count, is the only one that started in 2026, is one of 3 in phase 4, and was the 15th registered.

Esophagitis, Peptic

83 studies on the registry are indexed under Esophagitis, Peptic; 16 are open to participants now.

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Open to participants now

2 of the 15 studies in Esophagitis, Peptic with a site in United States are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 8 Esophagitis, Peptic studies recruiting now, 3 set no upper age limit and 3 stop at 75 or younger; none take children under 18; 1 takes healthy volunteers.

This study: 18 Years to 90 Years · all sexes · healthy volunteers too.

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02

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.

03

Conditions studied

  • Gastroesophageal Reflux Disease With Esophagitis

Browse trials for

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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

06

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Nov 2026 (actual). Primary completion is estimated for Dec 2027, 13 months after the start.

Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Nov 12, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2026
First posted
Sep 28, 2026
StartActual
Nov 1, 2026was Oct 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Apr 1, 2028
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Nov 12, 2026
Sites
1 site added — first site in United States
Show site
  • UF Health · Jacksonville, United States
Nov 12, 2026
Start date
Oct 2026→Nov 1, 2026 (actual)
Nov 12, 2026
Registered
First appeared on the registry
Sep 28, 2026
Show all 2 updates
  1. Nov 12, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in United States
    Show site
    • UF Health · Jacksonville, United States
    Start date Oct 2026→Nov 1, 2026 (now actual)
  2. Sep 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07843264
Responsible party
Sponsor
First posted
Sep 28, 2026
Start date
Nov 1, 2026
Primary completion
Dec 31, 2027 (estimated)
Completion
Apr 1, 2028 (estimated)
Last update
Nov 12, 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 ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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