At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 458 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 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg, 20 mg, and 40 mg Compared to Placebo for Relief of Episodic Heartburn in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease
In Brief
A Phase 2 clinical trial evaluating Vonoprazan and Placebo for Non-Erosive Gastro-Esophageal Reflux Disease and Heartburn. Completed, enrolled 458 participants across 63 sites.
Detailed Summary
The primary objectives of this study are to assess the efficacy of vonoprazan (10 mg, 20 mg, and 40 mg On-Demand) compared to placebo (On-Demand) in relief of episodic heartburn over 6 weeks in participants with symptomatic non-erosive gastroesophageal reflux disease (NERD), and to assess the safety of vonoprazan (10 mg, 20 mg, and 40 mg On-Demand) compared to placebo (On-Demand) in participants with symptomatic NERD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20222023202420252026
First PostedMar 2021
Enrollment StartMar 2021
Primary CompletionDec 2021
Study CompletionJan 2022
TodayJul 2026
First PostedMar 16, 2021
Enrollment StartMar 25, 2021
Primary CompletionDec 16, 2021
Study CompletionJan 17, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.3 years ago
Interventions
Vonoprazandrug
Orally via capsules
Placebodrug
Orally via capsules