A Randomized, Double-blind, Placebo-controlled, Multi-centers Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients (Phase3).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Recovered percentage(%) of the symptom
研究概览
简要总结
Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients
详细描述
This Phase 3 Clinical Trial is Designed as Randomized, Double-blind, Placebo-controlled, Multi-centers Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients (Phase3).
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, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A man or woman over 20 years old less than 70 years old.
- •A man or woman who has below all characters and diagnosis as NERD.
- •A man or woman who has experienced symptom(hearburn or/and acid regurgitation) over 3month at least.
- •A man or woman who has experienced symptom(heartburn or/and acid regurgitation) within 7days before Visit1, meet below 1) or 2) criteria.
- •** Symptom (heartburn and acid regurgitation) is confirmed by RDQ
- •Experienced above 2 days in a week, heartburn of acid regurgitation above the weakness.
- •Experienced above 1 day in a week, heartburn of acid regurgitation above the middle.
- •A man or woman who has been made diagnosis as LA grade0(Zero) measured through the dendoscopy which is corried out within 14 days, there is no observed muscosal break.
- •A man or woman who has a full understanding of this clinical trial through the detailed explanation, agree in writing to participate in this trial.
排除标准
- •Who has hyper sensitivity reaction about other drugs, ingredients, components of investigator product or compound of benzimidazole.
- •Who has ERD.
- •Who get a diagnosis as a IBS within the last 3 months.
- •Who have taken drugs about reflux esophagitis (H₂-receptor inhibitor (H2RA) Prostaglandin(PG), Antacid, Prokinetic acid etc.) above 2 times as an usual dose. (* refer to the Concomitant medication in text.)
- •Who havbe taken gastric acid secretion inhibitors including PPIs within 2 weeks before the endoscopy.
- •Who has been experienced the disease affecting the esophagus(Eosinophilic esophagitis, esophageal varices, cirrhosis, Virus or Fungal infection, Esophageal stricture, primary esophageal motility disorder and gastrointestinal bleeding). Or who has a history of radio therapeutics, freeze treatment about the esophagus.
- •Who has the gastric or duodenal ulcer, Zollinger-Ellison and other acid hypersecretory condition been experienced.
- •Who has hyper-sensitivity, reaction about PPIs (ex. Lansoprazole, omeprazole, rabeprazole, pantoprazole or esomeprazole).
- •Who has gotten a diagnosis as a cancer within 5 years before participated in this clinical trail (expect the basal cell on the skin), peptic ulcer or benign tumor.
研究组 & 干预措施
Nexium 20mg
Esomeprazole magnesium trihydrate, a substituted benzimidazole.
干预措施: Placebos (Drug)
YYD601 20mg
Esomeprazole magnesium Dihydrate.
干预措施: YYD601 20mg (Drug)
YYD601 20mg
Esomeprazole magnesium Dihydrate.
干预措施: Placebos (Drug)
Nexium 20mg
Esomeprazole magnesium trihydrate, a substituted benzimidazole.
干预措施: Nexium 20mg (Drug)
结局指标
主要结局
Recovered percentage(%) of the symptom
时间窗: within 4 weeks
Recovered percentage(%) of the symptom(heartburn or/and acid regurgitation) measured by RDQ after administration(baseline).
Percentage(%) of the patients who have symptom during the nighttime
时间窗: within 4 weeks
Percentage(%) of the patients who have symptom(heartburn or/and acid regurgitation) during the nighttime measured by Patients diary after administration(baseline).
Change of the score about the symptom
时间窗: within 4 weeks
Change of the score about the symptom(heartburn or/and acid regurgitation) measured by RDQ after administration(baseline).
Percentage(%) of the patients who have symptom during the daytime
时间窗: within 4 weeks
Percentage(%) of the patients who have symptom(heartburn or/and acid regurgitation) during the daytime measured by Patients diary after administration(baseline).
Percentage(%) of the days no symtom
时间窗: within 4 weeks
Percentage(%) of the days no symptom(heartburn or/and acid regurgitation) among the patients who have symptom(heartburn or/and acid regurgitation) during the nighttime measured by Patients diary after administration(baseline).
次要结局
未报告次要终点