At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 256 enrolled
Drug / intervention
Vonoprazan +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Proof-of-Concept, Phase 2 Study to Evaluate the Efficacy and Safety of Once Daily Oral Vonoprazan 20 mg or Vonoprazan 40 mg Compared to Esomeprazole 40 mg for the Treatment of Subjects With Symptomatic Gastro-Esophageal Reflux Disease Who Have a Partial Response Following Treatment With a High Dose of Proton Pump Inhibitor
In Brief
A Phase 2 clinical trial evaluating Vonoprazan, Esomeprazole, and 1 other intervention for Gastroesophageal Reflux. Completed, enrolled 256 participants across 39 sites in 6 countries.
Detailed Summary
The purpose of this study is to determine the effect of vonoprazan compared to esomeprazole for preventing heartburn symptoms over a 4-week treatment period in participants who have a partial response to treatment with esomeprazole.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux
CountriesBelgium, Bulgaria, Czechia, Estonia, Poland, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartJul 2016
Primary CompletionOct 2018
Study CompletionOct 2018
TodayJul 2026
First PostedApr 19, 2016
Enrollment StartJul 14, 2016
Primary CompletionOct 5, 2018
Study CompletionOct 12, 2018
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 10.2 years ago
Interventions
Vonoprazandrug
Vonoprazan over-encapsulated capsules
Esomeprazoledrug
Esomeprazole over-encapsulated tablets
Esomeprazole Placebodrug
Esomeprazole placebo-matching capsules