PPI Dosing Per CYP2C19 Genotype

NCT07843264 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB202600862
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gastroesophageal Reflux Disease With Esophagitis

Outcome Measures

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.

  8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

proton pump inhibitor dose based on CYP2C19 phenotypes

Drug: CYP2C19 based dosing Proton Pump Inhibitors

Control

ACTIVE COMPARATOR

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

Drug: Conventional proton pump inhibitor dose

Interventions

CYP2C19 based dosing Proton Pump Inhibitors DRUG

Pantoprazole dosing based on CYP2C19 phenotypes

Intervention

Conventional proton pump inhibitor dose DRUG

conventional PPI dose of Pantoprazole 40 mg once or twice daily

Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

MeSH Terms

Conditions

Esophagitis, Peptic

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Study Officials

• Ruchir Puri, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 28, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: September 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share