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Effectiveness of Vonoprazan vs Omeprazole as Empiric Therapy for Gastroesophageal Reflux Disease (GERD) Patients Without Alarm Features

NCT04028466 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2023-11-22

No results posted yet for this study

Summary

Gastroesophageal reflux disease is a commonly encountered disorder in daily practice. Proton pump inhibitor therapy has been the cornerstone of treatment for decades. Although it has been proven to be highly effective, there is still room for improvement. A local study showed that only 57.3% of subjects are asymptomatic after 4 weeks treatment with rabeprazole. Recently a new drug was developed with better absorption, higher bioavailability, more sustained increased pH in the stomach and more targeted action to the H-K ATPase pump. Vonoprazan, belongs to a new class of acid suppressant medications, the potassium-competitive acid blocker (P-CAB). Vonoprazan has been studied and used successfully in Japan for H pylori eradication therapy, GERD, gastric and duodenal ulcers with favorable safety profile. However, to the author's knowledge, no study yet exists comparing vonoprazan to a proton pump inhibitor in the treatment of GERD outside Japan. This study aims to determine whether vonoprazan is superior to omeprazole in relieving symptoms in treatment-naïve adult patients with GERD.

Conditions

  • GERD
  • Gastro Esophageal Reflux

Interventions

DRUG

Vonoprazan

Patients will be randomized to receiving vonoprazan 20mg tablet or omeprazole 40mg capsule, either of which will be taken 30 minutes before the first meal of the day for 14 days

DRUG

Omeprazole

Patients will be randomized to receving vonoprazan 20mg tablet or omeprazole 40mg capsule, either of which will be taken 30 minutes before the first meal of the day for 14 days

Sponsors & Collaborators

  • St. Luke's Medical Center, Philippines

    lead OTHER

Principal Investigators

  • Nicodemus L Ong, MD · Institute of Digestive and Liver Diseases, St. Luke's Medical Center, Quezon City

  • Sherrie Isabel Q De Ocampo, MD · Institute of Digestive and Liver Diseases, St. Luke's Medical Center, Quezon City

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-26
Primary Completion
2020-03-30
Completion
2020-03-30

Countries

  • Philippines

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04028466 on ClinicalTrials.gov