E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 629
- 试验地点
- 1
- 主要终点
- Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population.
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of rabeprazole sodium 10 mg in treating frequent heartburn.
详细描述
This is a multicenter, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn. The study will last for up to five weeks and consists of the following three phases: a one to two week screening period that includes a one-week, single-blind, placebo run-in phase, a two week double-blind, randomized treatment phase, and a one week single-blind, placebo follow-up phase.
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)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients > 18 years of age.
- •If female, not of childbearing potential by reason of surgery or menopause, or of childbearing potential, but using an approved method of contraception since the last menstrual period. Females of childbearing potential must have a negative serum pregnancy test before starting the study.
- •Patients must report a history of heartburn at least two days per week over the past month.
排除标准
- •History of erosive esophagitis verified by endoscopy.
- •History of gastroesophageal reflux disease (GERD) diagnosed by a physician.
- •Patients who have a history of Barrett's esophagus or esophageal stricture.
- •Evidence of any medical condition that may interfere with the conduct of the study, the interpretation of study results, or the health of the patient during the study.
- •Patients who require continuous use of proton pump inhibitors, histamine receptor (H2) blockers, or prokinetics. Prior intermittent use of these agents is permitted if they are discontinued at least three days prior to the run-in phase. The H2 blocker, cimetidine (Tagamet®), must be discontinued for at least seven days before the study drug is administered.
研究组 & 干预措施
Placebo
Oral placebo tablet
干预措施: Placebo (Other)
Rabeprazole sodium 10 mg
oral rabeprazole 10 mg enteric-coated tablet
干预措施: rabeprazole sodium (Drug)
结局指标
主要结局
Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population.
时间窗: first 24 hours
Subject was considered "complete relief" if he/she did not heartburn during the nighttime of the first dose date and no heartburn during the daytime of 1 day after the first dose date. The difference in complete relief within the first 24 hours between treatment groups was tested using a continuity corrected chi-square test without adjustment baseline heartburn severity.
次要结局
- Summary of Percentage of Heartburn-free Daytimes, Intent-to-Treat (ITT) Population(14-day treatment period.)
- Summary of Percentage of Heartburn-Free Nighttimes,Intent-to-Treat (ITT) Population(14-day treatment period.)
- Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole.(14-day treatment period.)
- Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole.(14-day treatment period.)