At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 776 enrolled
Drug / intervention
Vonoprazan +1 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 Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 10 and 20 mg Compared to Placebo for Relief of Heartburn in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD) After 4 Weeks and to Evaluate the Efficacy and Safety of Vonoprazan 10 and 20 mg for Relief of Heartburn in Subjects With NERD After 6 Months
In Brief
A Phase 3 clinical trial evaluating Vonoprazan and Placebo for Non-Erosive Gastro-Esophageal Reflux Disease and Heartburn. Completed, enrolled 776 participants across 108 sites.
Detailed Summary
The primary objectives of this study are to assess the efficacy of vonoprazan (10 mg and 20 mg once daily \[QD\]) compared to placebo (QD) in relief of heartburn over 4 weeks in participants with NERD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
Enrollment StartJan 2022
First PostedJan 2022
Primary CompletionNov 2022
Study CompletionMay 2023
TodayJul 2026
First PostedJan 19, 2022
Enrollment StartJan 17, 2022
Primary CompletionNov 21, 2022
Study CompletionMay 17, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.5 years ago
Interventions
Vonoprazandrug
Orally via capsule
Placebodrug
Orally via capsule