NCT05024721已完成3 期
A Multicenter, Randomized, Double-blind, Active-controlled, Phase Ⅲ Study to Evaluate the Efficacy and Safety of HIP2101 in Patients With Acute or Chronic Gastritis
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 326 人开始时间: 2021年8月9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
- 326
- 试验地点
- 1
- 主要终点
- Improvement rate of erosion
研究概览
简要总结
The purpose of this study is to investigate the safety and clinical efficacy of HIP2101 in patients with acute or chronic gastritis.
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
- 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
- •Have been diagnosed as acute or chronic gastritis with at least 1 erosion by endoscopy within 7 days before enrollment.
- •Patients understood the consents and purpose of this trial and signed consent form
排除标准
- •Patients who cannot perform endoscopy
- •Active gastric or duodenal ulcer
- •Reflux esophagitis, barrett's esophagus, gastric or esophageal varix
- •Zollinger-Ellison syndrome, pyloric obstruction, and esophageal stricture, Inflammatory Bowel Diease, acute pancreatitis
- •History of gastrointestinal surgery
- •History of malignancy tumor, especially in the upper gastrointestinal tract
- •Severe liver disorder(at screening day, AST or ALT level exceeds 3 times more than normal upper range)
- •Severe renal disorder(at screening day, MDRD eGFP ≤ 30 mL/min/1.73m2) or chronic renal disease
- •Bleeding disorder
- •Patients who have taken drugs containing following list within 2 weeks before endoscopy : H2-receptor antagonists, Proton pump inhibitors, P-CABs, gastrin inhibitors, antacids, gastric mucosal protectants, anticholinergics
- •Patients who have taken anticoagulants within a week before endoscopy
- •Patients who have taken drugs containing following list after endoscopy : GI tract regulators, salicylates, steroids, , NSAIDs, bisphosphonates, selective serotonin reuptake inhibitors, iron supplements, oriental herbal medicines
- •History of allergic reaction to the medications used in this study
- •Use of other investigational drugs within 30 days prior to the study
- •History of alcohol or drug abuse
- •Positive to pregnancy test, nursing mother, intention on pregnancy
- •Considered by investigator as not appropriate to participate in the clinical study with other reason
研究组 & 干预措施
HIP2101
Experimental
Taking HIP2101+HPP2102 once daily for 2 weeks.
干预措施: HIP2101 (Drug)
HIP2101
Experimental
Taking HIP2101+HPP2102 once daily for 2 weeks.
干预措施: HPP2102 (Drug)
RLD2101
Active Comparator
Taking RLD21012101+HPP2101 once daily for 2 weeks.
干预措施: RLD2101 (Drug)
RLD2101
Active Comparator
Taking RLD21012101+HPP2101 once daily for 2 weeks.
干预措施: HPP2101 (Drug)
结局指标
主要结局
Improvement rate of erosion
时间窗: week 2
percentage of subjects whose erosion score is improved by more than 50%
次要结局
- Improvement rate of erythema(week 2)
- Improvement rate of hemorrage(week 2)
- Cure rate of erosion(week 2)
- Cure rate of edema(week 2)
- Improvement rate of GI symptoms(week 2)
研究者
研究点 (1)
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