A Randomized, Double-blind, Double-dummy, Active Comparator, Multi-centers, Non-inferiority Design Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD) (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
- LA grade 0(zero)
研究概览
简要总结
A randomized, double-blind, double-dummy, active comparator, multi-centers, non-inferiority design clinical trial to assess the efficacy and safety of YYD601 in ERD patients (phase 3).
详细描述
This phase 3 clinical trial is designed as randomized, active-comparator, double-dummy, multi-center for ERD patients, who take YYD601 40mg or Nexium 40mg for 8 weeks. Each part is assessed by 'LA grade' measured through the endoscopy, target goal is to confirm the non-inferiority of YYD601 40mg to Nexium 40mg.
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 experienced symptom (heartburn and acid regurgitation) within 7 days before Visit 1, meet below 1) or 2) criteria, who has been made diagnosis as Erosive esophagitis(LA grade A~D) measured through the endoscopy which is carried out within (-2W±D2)
- •* Symptom (heartburn and acid regurgitation) is confirmed by RDQ.
- •Experienced above 2 days in 1 week, Heartburn of acid regurgitation above the weakness.
- •Experienced above 1 day in 1 week, Heartburn of acid regurgitation above the middle.
- •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 NERD
- •Who get a diagnosis as a IBS within the last 3 months.
- •Who have taken gastric acid secretion inhibitors including PPIs within 2 weeks before the endoscopy.
- •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 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 clinically significant abnormal result of ECG.
- •Abnormal result of Major arrhythmia, Multifocal PVS, 2 AV-blcok etc.
- •Who has the Schatzki near the LES(lower esophageal sphincter) except the Barret's esophagus.
研究组 & 干预措施
YYD601 40mg
Esomeprazole magnesium Dihydrate.
干预措施: YYD601 40mg (Drug)
YYD601 40mg
Esomeprazole magnesium Dihydrate.
干预措施: Placebos (Drug)
Nexium 40mg
Esomeprazole magnesium trihydrate, a substituted benzimidazole.
干预措施: Nexium 40mg (Drug)
Nexium 40mg
Esomeprazole magnesium trihydrate, a substituted benzimidazole.
干预措施: Placebos (Drug)
结局指标
主要结局
LA grade 0(zero)
时间窗: within 8 weeks
Percentage of patients(%) who's erosive esophagitis has been recovered to LA grade 0(zero) within week 8. Calculation of the sample size was based on a margin of non-inferiority by Normal approximation.
次要结局
- Frequency variation of the Heartburn in daytime by patients diary(at 4 week and 8 week from baseline)
- LA grade 0(zero)(at 4 weeks)
- Days percentage(%) of no symptoms about the Heartburn and acid regurgitation(at week 4 and 8 from baseline)
- Frequency variation of the Heartburn and acid regurgitation by RDQ(questionnaire).(at week 4 and 8 from baseline)
- Frequency variation of the Heartburn in nighttime by patients diary(at 4 week and 8 week from baseline)