NCT07730138尚未招募3 期
A Multinational, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group, Phase 3 Study to Evaluate the Efficacy and Safety of DWP14012 in Participants With Gastric Ulcer
Daewoong Pharmaceutical Co. LTD.2 个研究点 分布在 2 个国家目标入组 384 人开始时间: 2026年10月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 384
- 试验地点
- 2
- 主要终点
- Cumulative gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy through Week 8
研究概览
简要总结
A Multinational, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group, Phase 3 Study to Evaluate the Efficacy and Safety of DWP14012 in Participants 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)
盲法说明
Double-Blind
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one gastric ulcer is present, and the largest gastric ulcer measures ≥ 3 mm and ≤ 30 mm in diameter
- •The Sakita-Miwa classification of the largest gastric ulcer is A1 or A2.
排除标准
- •Participants with a history of Zollinger-Ellison syndrome or conditions associated with gastric hypersecretion.
- •Participants who, within 30 days prior to the screening visit (Visit 1), have undergone or are scheduled to undergo major surgery that may affect gastric acid secretion.
- •Participants with a history of malignancy within 5 years prior to the screening visit (Visit 1); gastrointestinal malignancies are excluded regardless of the time elapsed.
- •Participants who, at the screening visit (Visit 1), have gastrointestinal active bleeding , esophageal stricture, ulcer-induced stenosis, pyloric stenosis, gastroesophageal varices, Barrett's esophagus (> 3 cm), esophageal dysplasia, duodenal ulcer, refractory ulcer, perforated ulcer, or surgery-induced ulcer
- •Participants who, at the screening visit (Visit 1), have pancreatitis or inflammatory bowel disease (including Crohn's disease, ulcerative colitis, or intestinal Behçet's disease).
结局指标
主要结局
Cumulative gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy through Week 8
时间窗: Week 8
次要结局
- Change from baseline in gastric ulcer size assessed by upper gastrointestinal endoscopy(Week 4 and Week 8)
- Percentage change from baseline in gastric ulcer size assessed by upper gastrointestinal endoscopy at Week 4 and Week 8(Week 4 and Week 8)
- Gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy at Week 4(Week 4)
- Gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy at Week 4 according to H. pylori infection status.(Week 4)
- Cumulative gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy through Week 8 according to H. pylori infection status.(Week 8)
- Changes in NDI scores at Weeks 4 and 8.(Week 4 and Week 8)
- Changes in the number of gastric ulcers at Weeks 4 and 8.(Week 4 and Week 8)
研究者
研究点 (2)
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