NCT05813561已完成3 期
A Multicenter, Randomized, Double-Blind, Active-Parallel-Controlled, Phase 3 Clinical Study to Investigate the Efficacy and Safety of DWP14012 in the Treatment of Reflux Esophagitis
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 332 人开始时间: 2021年12月30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
- 332
- 试验地点
- 1
- 主要终点
- mucosal healing within 8 weeks
研究概览
简要总结
To evaluate the efficacy, safety, and cost-effectiveness of DWP14012 40 mg compared to esomeprazole magnesium enteric-coated tablets for the treatment of reflux esophagitis.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for this study:
- •Male or female subjects aged 18-75 years (inclusive);
- •Subjects with a confirmed diagnosis of reflux esophagitis (Grade A-D according to LA classification) by esophagogastroduodenoscopy (EGD) at our site within 7 days prior to Visit 2 (date of randomization).
- •Able to understand the information provided and to comply with protocol requirements;
- •Voluntarily agreed to participate in this clinical study and signed the informed consent form (ICF).
排除标准
- •1）Subjects who were allergic to the investigational drug and any of its components or esomeprazole magnesium enteric-coated tablets, other benzimidazole compounds and their components; 2）Subjects who were unable to undergo esophagogastroduodenoscopy (EGD); 3）Subjects with eosinophilic esophagitis, Barrett's esophagus (≥ 3 cm), gastroesophageal varices, stricture of oesophagus, active peptic ulcer, active upper/lower gastrointestinal bleeding, or malignancies confirmed by EGD; 4）Subjects with Zollinger-Ellison syndrome, achalasia, irritable bowel syndrome, or inflammatory bowel disease; 5）Subjects with concomitant diseases that may affect esophageal motility (e.g., dermatosclerosis, viral infection or fungal infection, etc.), or a history of esophageal radiotherapy or esophageal cryotherapy; 6）Subjects who had undergone surgery to reduce gastric acid secretion, or any surgery that affected the structure or function of the esophagus, stomach, or duodenum (excluding benign tumor excision, endoscopic resection of benign polyps, and simple suture procedures such as gastric perforation); 7）Subjects with warning symptoms (e.g., odynophagia, severe dysphagia, bleeding, weight loss, anemia, or hematochezia) of gastrointestinal malignancies (excluding those who did not have any endoscopically confirmed anatomical abnormalities of the esophagus or stomach); 8）Subjects with a medical history of serious hepatic, renal, neurological, respiratory, endocrine, hematological, cardiovascular, or genitourinary diseases; 9）Subjects with a history of malignancies within 5 years prior to screening (excluding those who had recovered from non-digestive malignancies for 5 years and have not relapsed); 10）Subjects with a medical history of psychiatric disorders (excluding those with psychiatric disorders who were currently stable as judged by the investigator and were not receive treatment), or drug or alcohol abuse within 12 months prior to screening; 11）Subjects who required continuous treatment with nonsteroidal anti-inflammatory drugs (e.g., aspirin), systemic glucocorticoids, and antithrombotic drugs during the study (excluding those who used low-dose aspirin [≤ 100 mg/day] prophylactically); 12）Subjects who were taking anti-retroviral drugs such as atazanavir and nelfinavir at screening; 13）Subjects who used therapeutic doses of drugs for gastroesophageal reflux disease within 7 days prior to randomization, such as proton pump inhibitors, potassium competitive acid blockers, histamine H2 receptor antagonists, mucosal protective drugs, drugs promoting gastrointestinal motility, and traditional Chinese medicinal products for gastroesophageal reflux disease; 14）Subjects with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin ≥ 2 × upper limit of normal (ULN); creatinine (Scr) ≥ 1.5 × ULN at screening; 15）Subjects who were positive for human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg) and/or hepatitis C virus (HCV) antibodies at screening; 16）Pregnant or lactating women; subjects of childbearing potential who were unable or unwilling to use adequate contraception from the time of signing the ICF until 30 days after the last dose or their partners were unwilling to use contraception; 17）Subjects who have participated and received treatment in clinical studies of other drugs, devices, etc. within 3 months prior to screening; 18）Subjects who were ineligible (for any reason) to participate in the study as judged by the investigator.
研究组 & 干预措施
DWP14012
Experimental
干预措施: DWP14012 (Drug)
Lansoprazole
Active Comparator
干预措施: DWP14012 (Drug)
结局指标
主要结局
mucosal healing within 8 weeks
时间窗: 8weeks
The percentage of subjects with endoscopically confirmed mucosal healing within 8 weeks.
次要结局
未报告次要终点
研究者
研究点 (1)
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