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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 458
- 试验地点
- 60
- 主要终点
- Percentage of Evaluable Heartburn Episodes Completely Relieved Within 3 Hours and With No Further Heartburn Reported for 24 Hours After Taking Study Drug
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
During the Run-In Period, participants will receive open-label vonoprazan.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Run-In Period
Participants will receive vonoprazan 20 mg once daily for up to 4 weeks.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Evaluable Heartburn Episodes Completely Relieved Within 3 Hours and With No Further Heartburn Reported for 24 Hours After Taking Study Drug
时间窗: 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.
次要结局
- 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)