A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Group Proof-of-Concept Trial to Assess Relief of Meal Induced Heartburn by a Combination of Lansoprazole 15 mg and Antacid Versus Lansoprazole 15 mg and Antacid (Calcium Carbonate and Magnesium Hydroxide) Alone
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 120
- 主要终点
- Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal
研究概览
简要总结
This study will investigate the safety and efficacy of an antacid/Lansoprazole combination product for the relief of heartburn after consuming a heartburn-inducing meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Experiencing heartburn in the past month if untreated
- •Having heartburn that responds to heartburn medication
- •Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study.
排除标准
- •Having history of erosive esophagitis or gastroesophageal reflux disease (GERD) diagnosed by a physician and confirmed by testing (endoscopy)
- •Be unwilling to take only the study medication, and antacid provided as a rescue medication for relief of acute heartburn during the study.
- •"Other protocol-defined inclusion/exclusion criteria may apply"
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
Combination product
Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet
干预措施: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg (Drug)
PPI alone
Lansoprazole
干预措施: Lansoprazole (Drug)
Antacid alone
Calcium carbonate/magnesium hydroxide
干预措施: Calcium carbonate/magnesium hydroxide (Drug)
结局指标
主要结局
Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal
时间窗: 1 day
Participant reported severity of heartburn using a Visual Analog Scale (VAS)directly on CRF every 15 minutes until no heartburn reported or up to 5 hours after 1st heartburn-inducing meal, whichever occurred first. At this point in time, a diary was provided to participants to record any changes in severity of heartburn for 28 hours post treatment.
次要结局
- Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals(1 day)
- Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn(1 day)
- Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo.(1 day)