NCT05656092已完成3 期
A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Study to Evaluate the Efficacy and Safety of HIP0612 in Patients with Gastric Ulcer
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 199 人开始时间: 2023年3月6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
- 199
- 试验地点
- 1
- 主要终点
- Healing rate of gastric ulcer
研究概览
简要总结
A multicenter, randomized, double-blind, active-controlled, phase III study to evaluate the efficacy and safety of HIP0612 in patients with gastric ulcer.
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 years to 75 years
- •Diagnosis of active gastric ulcers according to the Sakita-Miwa classification from upper GI endoscopy
- •Patients understood the consents and purpose of this trial and signed consent form
排除标准
- •Patients who cannot perform endoscopy
- •Finding of malignancy, duodenal ulcer, ulcer perforation, postoperative (eg, endoscopic mucosal resection, endoscopic submucosal dissection) ulcer(s), Barrett's oesophagus measuring >3cm, oesophageal dysplasia, oesophageal and/or gastric varices, bleeding disorder on upper GI endoscopy
- •History of definitive acid lowering surgery or pervious oesophageal or gastric surgery (except for benign tumor excisionn, simple close of perforations)
- •Zollinger-Ellison syndrome, pyloric stenosis, oesophageal motility disorder, esophageal stricture
- •Severe hepatic disease
- •Severe renal disease, CKD
- •Bleeding disorder
- •History of malignancy or was treated for malignancy within 5 years before the start of the Visit 1
- •Patients who have taken drugs containing following list within 2 weeks prior to upper GI endoscopy, or requirement of persistent use of drugs during the study period: acid suppressive drugs, antacids, anticholinergic drugs, gastroprotective agent
- •Patients who have taken drugs containing following list within 1 weeks prior to upper GI endoscopy, or requirement of persistent use of drugs during the study period: antithrombotic agents, NSAIDs, aspirin
- •Requirement of use of excluded medications during the study
- •History of allergic reaction to the medications used in this study
- •Glucose-galactose malabsorption, Fructose intolerance, Sucrase-isomaltase deficiency
- •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
HIP0612
Experimental
Taking HIP0612+HPP2202 once daily for 4 or 8 weeks.
干预措施: HIP0612 (Drug)
HIP0612
Experimental
Taking HIP0612+HPP2202 once daily for 4 or 8 weeks.
干预措施: HPP2202 (Drug)
RLD2204
Active Comparator
Taking RLD2204+HPP2201 once daily for 4 or 8 weeks.
干预措施: RLD2204 (Drug)
RLD2204
Active Comparator
Taking RLD2204+HPP2201 once daily for 4 or 8 weeks.
干预措施: HPP2201 (Drug)
结局指标
主要结局
Healing rate of gastric ulcer
时间窗: week 8
Including subjects endoscopically confirmed healing of gastric ulcer after 4 Weeks of treatment and complete the study
次要结局
- Healing rate of gastric ulcer(week 4)
- Healing rate of gastric ulcer according to H.pylori infection status(week 4, 8)
- Post-treatment resolution rate of GI symptoms(week 4, 8)
研究者
研究点 (1)
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