NCT04325620已完成3 期
A Multicenter, Randomized, Parallel, Double-Blinded, Placebo-controlled Phase 3 Study to Compare Efficacy and Safety of HIP1601 in Patients With Non-Erosive Gastroesophageal Reflux Disease(NERD)
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2019年6月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Percentage of patients with complete resolution of major symptoms at 4-week
研究概览
简要总结
The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with Non-erosive gastroesphageal reflux disease.
详细描述
A Multicenter, Randomized, Parallel, Double-Blinded, Placebo-controlled Phase Ⅲ Study to Compare Efficacy and Safety of HIP1601 in Patients with Non-Erosive Gastroesophageal 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19≤ age ≤ 75
- •Patients who were not observed mucosal break('not present') according to the LA classification(LA grade) on the EGDEsophago-Gastro-Duodenoscopy
- •Patients who had experienced major symptom within 3 months Patients experienced heartburn or acid regurgitation within 7 days of screening day
- •Patients who had experienced major symptom within 7 days before randomization. Entry into study also required that patients had experienced at least mild symptoms on at least 2 days/week or at least moderate symptoms on at least 1 day/week based on RDQ
- •Patients understood the consents and purpose of this trial and signed consent form
排除标准
- •Patients who have erosive GERD, Barrett's esophagus(other significant dysplasia of esophagus), gastroesophageal varicose veins, active peptic ulcer, gastrointestinal bleeding or malignant GI tumor confirmed by endoscopy
- •Patients who have a history of gastric or gastroesophageal surgery
- •Patients who have Zollinger-Ellison syndrome, eosinophilic esophagitis, primary esophageal motility disorder, acute upper gastrointestinal bleeding, Functional dyspepsia, IBS, IBD within 3 months before Visit 1
- •Patients with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease.
- •Patients Has a severe liver disorder(AST or ALT level exceeds 3 times more than normal upper range at Visit 1)
- •Has a clinically significant renal failure(MDRD eGFR ≤ 59 mL/min/1.73m2 or Serum creatinine >2.0mg/dL at Visit 1)
研究组 & 干预措施
HIP1601 Amg
Experimental
The participants will receive tretment of HIP1601 Amg, orally, once daily for 4weeks.
干预措施: HIP1601 (Drug)
HGP1805
Placebo Comparator
The participants will receive tretment of HGP1805(Placebo of HIP1601), orally, once daily for 4weeks.
干预措施: HGP1805 (Drug)
结局指标
主要结局
Percentage of patients with complete resolution of major symptoms at 4-week
时间窗: 4 week
Complete resolution is defined as no episodes of symptom during the last 7 days of treatment.
次要结局
- Major symptoms-Free days(1, 4 week)
- Frequency and Severity of Reflux disease symptom assessment using Reflux Disease Questionnaire(RDQ)(2, 4 week)
- Percentage of patients with complete resolution of major symptoms at 2-week(2 week)
- Time to complete resolution of major symptoms(4 week)
- Quality of Life assessment using Patient Assessment of upper Gastrointestinal disorders-Quality of Life(PAGI-QoL)(4 week)
- Resolution rate of major symptoms of first 7 days(1 week)
- Proportion of rescue medication amounts(4 week)
研究者
研究点 (1)
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