NCT04080726已完成3 期
A Multicenter, Randomized, Double-blind, Phase Ⅲ Study to Compare Efficacy and Safety of HIP1601 40mg and HGP1705 40mg in Patients With Erosive Gastroesophageal Reflux Disease
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 213 人开始时间: 2018年10月25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
- 213
- 试验地点
- 1
- 主要终点
- Complete healing rate
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 erosive gastroesphageal reflux disease.
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)
盲法说明
double-blind
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
- •Esophago-Gastro-Duodenoscopy LA classification ≥ grade A
- •Patients experienced heartburn or acid regurgitation within 7 days of screening day
- •Patients understood the consents and purpose of this trial and signed consent form
排除标准
- •Has malignancy in the upper gastrointestinal tract, digestive ulcer, bleeding disorder or signs of gastrointestinal bleeding
- •Has a severe liver disorder(at screening day, AST or ALT level exceeds 3 times more than normal upper range)
- •Has a clinically significant renal failure(at screening day, MDRD eGFP ≤ 59 mL/min/1.73m2 or Serum creatinine >2.0mg/dL)
- •Uncontrolled diabetes mellitus
- •Before screening EGD, a patient who has taken H2-receptor antagonist or PPI within 2 weeks
- •Before screening EGD, a patient who has taken drugs containing following list within 1 weeks : warfarin, anticholinergics for spasmolytic GI, antineoplastic agents, salicylates(except 100mg a day for prevention of cardiovascular disease), steroids, propulsives, sucralfate, NSAIDs, other antacids(e.g. antacids of prostaglandin analogs, antacids of aluminum/magnesium)
研究组 & 干预措施
HIP1601+HGP1705 Placebo
Experimental
HIP1601+HGP1705 Placebo for 4weeks. if not fully cured, take HIP1601+HGP1705 Placebo for addtional 4weeks
干预措施: HIP1601 (Drug)
HIP1601+HGP1705 Placebo
Experimental
HIP1601+HGP1705 Placebo for 4weeks. if not fully cured, take HIP1601+HGP1705 Placebo for addtional 4weeks
干预措施: HGP1705 Placebo (Drug)
HGP1705+HIP1601 Placebo
Experimental
HGP1705+HIP1601 Placebo for 4weeks. if not fully cured, take HGP1705+HIP1601 Placebo for addtional 4weeks
干预措施: HGP1705 (Drug)
HGP1705+HIP1601 Placebo
Experimental
HGP1705+HIP1601 Placebo for 4weeks. if not fully cured, take HGP1705+HIP1601 Placebo for addtional 4weeks
干预措施: HIP1601 Placebo (Drug)
结局指标
主要结局
Complete healing rate
时间窗: at 4 weeks or 8 weeks
percentage of subjects whose erosion is completely cured
次要结局
- Complete healing rate(at 4 weeks)
- Time to sustained resolution heartburn, acid regurgitation(at 4 weeks or 8 weeks)
- Total number of use of relief drugs and average usage per day(at 4 weeks or 8 weeks)
- Complete resolution rate of each symptom in GERD(at 4,8 weeks)
- Proportion of heartburn-free days, acid regurgitation-free days(at 1, 2, 4, 8 weeks)
- Proportion of heartburn-free nights, acid regurgitation-free nights(at 1, 2, 4, 8 weeks)
- Time to sustained resolution of nocturnal heartburn, nocturnal acid regurgitation(at 4 weeks or 8 weeks)
研究者
研究点 (1)
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