Randomized, Controlled, Single-blind, Three-way Crossover Clinical Investigation to Evaluate Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Difference in time to both onset of soothing and onset of cooling after intake of investigational product between study arms
研究概览
简要总结
This study is a randomized, placebo-controlled, single-blind, three-way crossover clinical trial to evaluate safety and efficacy of IQP-LH-101 (tablet form and liquid form) in postprandial heartburn.
The null hypothesis is that there is no difference between IQP-LH-101 and the placebo in terms of efficacy for postprandial heartburn treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Post-prandial heartburn (e.g. after a high-fat meal) in at least 2 months prior to the study (at least 2 times a week)
- •Not receiving prescribed treatment for heartburn, reflux or upper gastrointestinal disorders
- •Written informed consent is a prerequisite for subject enrollment.
排除标准
- •Gastrointestinal bleeding within 12 months prior to the study
- •Difficulty swallowing (dysphagia)
- •History of or symptoms suggestive of Zollinger-Ellison syndrome, oesophageal or gastric malignancy, gastric or duodenal ulcer, pernicious anaemia, Barrett's oesophagus or systemic sclerosis
- •Participation in other studies within the last 30 days prior to entry or during the study
研究组 & 干预措施
Placebo
1 tablet to be swallowed with water.
干预措施: Placebo (Other)
IQP-LH-101 tablet
4 chewable tablets to be chewed thoroughly before swallowing
干预措施: IQP-LH-101 tablet (Device)
IQP-LH-101 liquid
2 liquid sachets to be emptied into the mouth and consumed.
干预措施: IQP-LH-101 liquid (Device)
结局指标
主要结局
Difference in time to both onset of soothing and onset of cooling after intake of investigational product between study arms
时间窗: Measured up to 30 minutes
The subject will be provided with a stopwatch started by the study staff at the time of investigational product application
次要结局
- Duration of time until the first perception of recurring heartburn symptoms after intake of investigational product(Up to 4 hours)
- Adverse events(Up to 4 weeks)
- Evaluation of efficacy(Up to 4 hours per crossover)