Randomized, Double-blind, Active-controlled, Multi-center Phase 2 Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH1885L in Patients With Non-erosive Reflux Disease(NERD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 149
- 试验地点
- 10
- 主要终点
- the rate of subject who had 'complete recovery' of symptom after 4 week administration
研究概览
简要总结
Randomized, double-blind, active-controlled, multi-center phase 2 clinical trial to investigate the safety, tolerability and efficacy of YH1885L in patients with non-erosive reflux disease(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)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects who signed written informed consent form
- •more than 20 yr subject
- •subjects who agree the use of medically accepted birth control during trial
- •grade N, M by EGD test
- •subject who experience 2 day out of 1 week during recent 1 month
- •subject who experience 2 day out of 1 week during run-in period
排除标准
- •subjects who can write the diary by himself, herself
- •pregnant woman, breastfeeding woman
- •allgeric or intolerabiliy to revaprazan or esomeprazole
- •feeling of heavy stomach, distention
- •surgery history in stomach or esophagus
- •active medical history of stomach, esophagus area
- •other system disorder which can disturb this trial
- •Hep B, C virus, HIV carrier or patients
- •past history of malignant tumor
- •any psychiatric past or current history
- •abnormal lab test
- •abnormal ecg test
- •zollinger-ellison disease
- •current or past history of substance, drug abuse
- •subject who should regulary takes medication which can disturb this trial
研究组 & 干预措施
YH1885L 33.3 mg
TID, Subject takes it for 4 week.
干预措施: YH1885L(Revaprazan) (Drug)
YH1885L 50mg
BID, Subject takes it for 4 week.
干预措施: YH1885L(Revaprazan) (Drug)
YH1885L 50mg
BID, Subject takes it for 4 week.
干预措施: placebo (Drug)
YH1885L 66.6 mg
TID, Subject takes it for 4 week.
干预措施: YH1885L(Revaprazan) (Drug)
YH1885L 100mg
BID, Subject takes it for 4 week.
干预措施: YH1885L(Revaprazan) (Drug)
YH1885L 100mg
BID, Subject takes it for 4 week.
干预措施: placebo (Drug)
Esomeprazole 20mg
QD, Subject takes it for 4 week.
干预措施: Esomeprazole 20mg (Drug)
Esomeprazole 20mg
QD, Subject takes it for 4 week.
干预措施: placebo (Drug)
结局指标
主要结局
the rate of subject who had 'complete recovery' of symptom after 4 week administration
时间窗: 4 week
'complete recovery' means subjects never experience heartburn or acid regurgitation during last 1 week.
次要结局
- Evalution of Clinical Global Impression of Change(4 week)
- Evaluation of Patient Global Impression of Change(4 week)
- the rate of subject who had 'appropriate recovery' of symptom after 4 week administration(4 week)
- the rate of subject who had 'appropriate recovery' after 1 week, 2 week, 3 week IP administraion(3 week)
- the number of night symptom-free day after IP administration(1 week, 2 week, 3 week, 4 week)
- the rate of subject who had 'complete recovery' after 1 week, 2 week, 3 week IP administraion(3 week)
- the change of ESS survey score among baseline, 2 week and 4 week(2, 4 week)
- the rate of subjects who have reduced average symptom score(more than 1) comparing to baseline score(1 week, 2 week, 3 week, 4 week)
- Safety(4 week)
- the change of SF-36 Survey score between baseline and completion visit(4 week)