Gastroesophageal Reflux Disease With EsophagitisPhase 4NCT07843264
PPI Dosing Per CYP2C19 Genotype
A Phase 4 study testing CYP2C19 based dosing Proton Pump Inhibitors and Conventional proton pump inhibitor dose in people with Gastroesophageal Reflux Disease With Esophagitis, run by University of Florida.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease With Esophagitis
- What is being tested?
- CYP2C19 based dosing Proton Pump Inhibitors and Conventional proton pump inhibitor dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to 1 Apr 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥ 18 years
- diagnosis of Gastroesophageal Reflux Disease (GERD) scheduled for an esophagogastroduodenoscopy (EGD)
- patients diagnosed with Erosive Esophagitis on endoscopy (EGD).
Who cannot join
- age <18 years
- diagnosed with non-erosive reflux disease (NERD)
- pregnancy
About this study
Official title: A Pilot Study to Assess Healing of Erosive Esophagitis in Patients Randomized to Conventional PPI Doses Versus Dosing Based on CYP2C19 Genotype
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.
- Being tested
- CYP2C19 based dosing Proton Pump Inhibitors, Conventional proton pump inhibitor dose
- Medical subject headings
- Esophagitis, Peptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYP2C19 based dosing Proton Pump InhibitorsDrug
Pantoprazole dosing based on CYP2C19 phenotypes
Conventional proton pump inhibitor doseDrug
conventional PPI dose of Pantoprazole 40 mg once or twice daily
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | proton pump inhibitor dose based on CYP2C19 phenotypes Receives: Drug: CYP2C19 based dosing Proton Pump Inhibitors |
| Control | Active comparator | conventional proton pump inhibitor dose of Pantoprazole 40 mg once or twice daily Receives: Drug: Conventional proton pump inhibitor dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study startOct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux Disease With EsophagitisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruchir Puri, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843264
- Sponsor's protocol ID
- IRB202600862
- Status last verified
- Jul 2026
- First submitted
- 11 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess Healing of Erosive Esophagitis in Patients Randomized to Conventional PPI Doses Versus Dosing Based on CYP2C19 Genotype
- ClinicalTrials.gov ID
- NCT07843264
- Acronym / sponsor ID
- IRB202600862
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: CYP2C19 based dosing Proton Pump Inhibitorsproton pump inhibitor dose based on CYP2C19 phenotypes |
| Control | Active comparator | Drug: Conventional proton pump inhibitor doseconventional proton pump inhibitor dose of Pantoprazole 40 mg once or twice daily |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 18 years
- diagnosis of Gastroesophageal Reflux Disease (GERD) scheduled for an esophagogastroduodenoscopy (EGD)
- patients diagnosed with Erosive Esophagitis on endoscopy (EGD).
Key exclusion criteria (3 listed)
- age <18 years
- diagnosed with non-erosive reflux disease (NERD)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYP2C19 based dosing Proton Pump InhibitorsPantoprazole dosing based on CYP2C19 phenotypes | Drug | Intervention |
| Conventional proton pump inhibitor doseconventional PPI dose of Pantoprazole 40 mg once or twice daily | Drug | Control |
Primary outcome
Improvement of Los Angeles (LA) classification of Erosive Esphagitis (EE) grade
Time frame: 8 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ruchir Puri, MD principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CYP2C19 based dosing Proton Pump Inhibitors and Conventional proton pump inhibitor dose in people with Gastroesophageal Reflux Disease With Esophagitis, run by University of Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of Los Angeles (LA) classification of Erosive Esphagitis (EE) grade (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.