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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 458
- Locations
- 60
- Primary Endpoint
- Percentage of Evaluable Heartburn Episodes Completely Relieved Within 3 Hours and With No Further Heartburn Reported for 24 Hours After Taking Study Drug
Study Overview
Brief 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
During the Run-In Period, participants will receive open-label vonoprazan.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Run-In Period
Participants will receive vonoprazan 20 mg once daily for up to 4 weeks.
Intervention: Vonoprazan (Drug)
Vonoprazan 10 mg: On-Demand Treatment Period
Participants who have stable disease (no heartburn on the last 7 days of the Run-In Period) will take vonoprazan 10 mg when heartburn occurs during the 6 week On-Demand Treatment Period. Participants can take no more than one dose in a 24 hour period.
Intervention: Vonoprazan (Drug)
Vonoprazan 20 mg: On-Demand Treatment Period
Participants who have stable disease (no heartburn on the last 7 days of the Run-In Period) will take vonoprazan 20 mg when heartburn occurs during the 6 week On-Demand Treatment Period. Participants can take no more than one dose in a 24 hour period.
Intervention: Vonoprazan (Drug)
Vonoprazan 40 mg: On-Demand Treatment Period
Participants who have stable disease (no heartburn on the last 7 days of the Run-In Period) will take vonoprazan 40 mg when heartburn occurs during the 6 week On-Demand Treatment Period. Participants can take no more than one dose in a 24 hour period.
Intervention: Vonoprazan (Drug)
Placebo: On-Demand Treatment Period
Participants who have stable disease (no heartburn on the last 7 days of the Run-In Period) will take a placebo when heartburn occurs during the 6 week On-Demand Treatment Period. Participants can take no more than one dose in a 24 hour period.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Percentage of Evaluable Heartburn Episodes Completely Relieved Within 3 Hours and With No Further Heartburn Reported for 24 Hours After Taking Study Drug
Time Frame: On-Demand Treatment Period: Day 1 to Day 42
An evaluable heartburn episode was an episode for which study drug was taken and for which the participant completed at least one entry in the heartburn episode diary. For a heartburn episode to be considered completely relieved, a participant must not have taken rescue antacid within 3 hours of taking study drug. For sustained relief, complete relief must have been accompanied by 24 hours without another heartburn episode after taking study drug.
Secondary Outcomes
- Percentage of Evaluable Heartburn Episodes Completely Relieved Within 3 Hours After Taking Study Drug(On-Demand Treatment Period: Day 1 to Day 42)
- Percentage of Evaluable Heartburn Episodes for Each Participant That Are Completely Relieved Within 3 Hours and With No Further Heartburn Reported for 24 Hours After Taking Study Drug(On-Demand Treatment Period: Day 1 to Day 42)
- Mean Number of Tablets of Rescue Antacid Taken Per Day Over the On-Demand Treatment Period(On-Demand Treatment Period: Day 1 to Day 42)
- Percentage of Participants With Complete Relief of Heartburn Within 3 Hours After the First Episode and With No Further Heartburn Reported for 24 Hours After Taking Study Drug(On-Demand Treatment Period: Day 1 to Day 42)
- Percentage of Days Study Drug Was Taken Over the On-Demand Treatment Period(On-Demand Treatment Period: Day 1 to Day 42)
- Percentage of 24-Hour Heartburn-Free Days Over the On-Demand Treatment Period(On-Demand Treatment Period: Day 1 to Day 42)