A Randomized, Double-blind, Three-fold Cross-over, Multi-center Study to Compare the Efficacy and Safety of a Single Dose of Oral Talcid (1000 mg Hydrotalcite), a Single Dose of Oral Famotidine 10 mg, and a Single Dose of Placebo in Patients With Acute Heartburn Episodes.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 559
- 主要终点
- Total heartburn relief over 0-60 min
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of a single oral administration of 1000 mg Talcid® (study medication), a single oral administration of 10 mg famotidine and a single oral administration of placebo (comparator without an active substance) in treating the symptoms of acute heartburn episodes. The study is designed to collect more efficacy data on Talcid® in patients using self-medication to relief the symptoms of acute heartburn.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Male or female between the age of 18 to 65 years
- •A minimum of 6 months history of heartburn
- •History of relief of heartburn episodes after self-medication (OTC use) within at least 2 hours
- •Occurrence of heartburn episodes at least twice a week during the previous two months
- •Severity of heartburn episodes at least 5 on an 11-category heartburn severity scale
排除标准
- •History of 'alarming symptoms' e.g. weight loss, vomiting, dysphagia, anemia, hematemesis or melaena
- •History of gastric ulcer or gastroesophageal reflux disease requiring regular or intermittent therapy with H2-antagonists or proton pump inhibitors within the previous year
- •History of significant gastrointestinal hemorrhage or gastrointestinal surgery
- •Gastrointestinal odynophagia (pain during swallowing)
- •History or concurrent known duodenitis, pyloric dysfunction with alkaline reflux, motility disturbances, Heliobacter pylori gastritis, or cholelithiasis
- •Pregnant or lactating women, or sexually active women of child-bearing potential unless using effective contraception
研究组 & 干预措施
Arm PHF
1st heartburn episode Intervention Placebo, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Famotidine
干预措施: Placebo (Drug)
Arm HFP
1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Famotidine, 3rd heartburn episode Placebo
干预措施: Talcid (Hydrotalcite, BAY4516H) (Drug)
Arm HFP
1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Famotidine, 3rd heartburn episode Placebo
干预措施: Famotidine (Drug)
Arm HFP
1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Famotidine, 3rd heartburn episode Placebo
干预措施: Placebo (Drug)
Arm HPF
1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Placebo, 3rd heartburn episode Famotidine
干预措施: Talcid (Hydrotalcite, BAY4516H) (Drug)
Arm HPF
1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Placebo, 3rd heartburn episode Famotidine
干预措施: Famotidine (Drug)
Arm HPF
1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Placebo, 3rd heartburn episode Famotidine
干预措施: Placebo (Drug)
Arm FHP
1st heartburn episode Intervention Famotidine, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Placebo
干预措施: Talcid (Hydrotalcite, BAY4516H) (Drug)
Arm FHP
1st heartburn episode Intervention Famotidine, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Placebo
干预措施: Famotidine (Drug)
Arm FHP
1st heartburn episode Intervention Famotidine, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Placebo
干预措施: Placebo (Drug)
Arm FPH
1st heartburn episode Intervention Famotidine, 2nd heartburn episode Placebo, 3rd heartburn episode Hydrotalcid
干预措施: Talcid (Hydrotalcite, BAY4516H) (Drug)
Arm FPH
1st heartburn episode Intervention Famotidine, 2nd heartburn episode Placebo, 3rd heartburn episode Hydrotalcid
干预措施: Famotidine (Drug)
Arm FPH
1st heartburn episode Intervention Famotidine, 2nd heartburn episode Placebo, 3rd heartburn episode Hydrotalcid
干预措施: Placebo (Drug)
Arm PHF
1st heartburn episode Intervention Placebo, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Famotidine
干预措施: Talcid (Hydrotalcite, BAY4516H) (Drug)
Arm PHF
1st heartburn episode Intervention Placebo, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Famotidine
干预措施: Famotidine (Drug)
Arm PFH
1st heartburn episode Intervention Placebo, 2nd heartburn episode Famotidine, 3rd heartburn episode Hydrotalcid
干预措施: Talcid (Hydrotalcite, BAY4516H) (Drug)
Arm PFH
1st heartburn episode Intervention Placebo, 2nd heartburn episode Famotidine, 3rd heartburn episode Hydrotalcid
干预措施: Famotidine (Drug)
Arm PFH
1st heartburn episode Intervention Placebo, 2nd heartburn episode Famotidine, 3rd heartburn episode Hydrotalcid
干预措施: Placebo (Drug)
结局指标
主要结局
Total heartburn relief over 0-60 min
时间窗: up to 60 minutes
The total heartburn relief is claculated as sum of the heartburn relief scores based on a 5-point verbal rating scale.
次要结局
- Total heartburn relief 0-30 min after comparison hydrotalcite vs. placebo and vs famotidine(up to 30 min)
- Total heartburn relief 0-3 h after comparison hydrotalcite vs. placebo and vs famotidine(up to 3 h)