PPI Dosing Per CYP2C19 Genotype

ConditionGastroesophageal Reflux Disease With Esophagitis

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-90

SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

age ≥ 18 years

diagnosis of Gastroesophageal Reflux Disease (GERD) scheduled for an esophagogastroduodenoscopy (EGD)

patients diagnosed with Erosive Esophagitis on endoscopy (EGD).

Disqualifiers

age <18 years

diagnosed with non-erosive reflux disease (NERD)

pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

CYP2C19 based dosing Proton Pump Inhibitors
Drug
Pantoprazole dosing based on CYP2C19 phenotypes
Conventional proton pump inhibitor dose
Drug
conventional PPI dose of Pantoprazole 40 mg once or twice daily

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: InterventionExperimental treatment 1 intervention

Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: