Vonoprazan study In patients with erosive esophagitis to evaluate long-term safety: A study to evaluate the safety of long-term administration of vonoprazan in maintenance treatment in patients with erosive esophagitis (EE)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Number of Participants with Malignant Alteration of Epithelial Cells
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multicenter, open-label, randomized, parallel-group study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •< At the start of healing phase >
- •Participants endoscopically diagnosed with EE of grades A to D by the LA Classification Grading System at the start of treatment (Week 0 of the healing phase)
- •Participants with H. pylori negative
- •Participants who, in the opinion of the principal investigator or investigator, are capable of understanding the content of the clinical research and complying with the research protocol requirements.
- •Participants who can sign and date an informed consent form and information sheet prior to the conduction of the clinical research procedures.
- •Male or female participants aged 20 years or older at the time of informed consent
- •Therapeutic category: Ambulatory
- •< At the start of maintenance phase >
- •Participants who have endoscopically confirmed EE healing* (mucous membrane disorder is not observed) at completion of the healing phase (Week 4 or 8 of the healing phase)
- •Participants who are classified as grade 0 according to severity classification of EE
- •Participants who have been determined to be appropriate as subjects for maintenance treatment of EE by the principal investigator or investigator
排除标准
- •< At the start of healing phase >
- •Participants with concurrent peptic ulcer (except scarred stage) or Zollinger-Ellison syndrome
- •Participants who received treatment with PPIs (including vonoprazan) within 4 weeks (Week -4 to Week 0) prior to the start of healing phase (Week 0 of the healing phase)
- •Participants with a history of H. pylori eradication.
- •Participants who have received surgery or treatment affecting gastroesophageal reflux (fundoplication or dilation for esophageal stenosis [excluding Schatzki's ring], etc.)
- •Participants with an esophagus-related complication (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal stenosis, etc.), a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) or Barrett's esophagus are allowed to be included.
- •Participants with clinically apparent hepatic impairment (e.g., AST or ALT levels at the time of informed consent: >1.5 times the upper limit of normal (ULN).
- •Participants with renal impairment or renal failure [creatinine clearance (CCr) <30 mL/min, etc.]
- •Participants with a history of hypersensitivity or allergy for PPIs.
- •Participants with a history of gastrectomy, gastrointestinal resection, or vagotomy
- •Participants with a malignant tumor
- •Participants who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant
- •Participants with one of the diseases listed under administration contraindication in the vonoprazan or lansoprazole package insert
- •Participants planning to take prohibited concomitant medications during the research period
- •Participants participating in other clinical studies
- •Participants who have been determined to be inappropriate as subjects in the study by the principal investigator or investigator
- •<At the start of maintenance phase >
- •Participants who have taken PPIs other than the study drug or the control drug during the healing phase
- •Participants who have been determined to be inappropriate as subjects in the study by the principal investigator or investigator
结局指标
主要结局
Number of Participants with Malignant Alteration of Epithelial Cells
时间窗: Up to Week 268 (Week 260 in Maintenance Phase)
Numbers of participants with Malignant alteration of epithelial cells for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.
Number of Participants with Parietal Cell Protrusion/Hyperplasia
时间窗: Up to Week 268 (Week 260 in Maintenance Phase)
Numbers of participants with parietal cell protrusion/hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.
Number of Participants with Foveolar Hyperplasia
时间窗: Up to Week 268 (Week 260 in Maintenance Phase)
Numbers of participants with foveolar hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.
Number of Participants with Enterochromaffin-like-cell Hyperplasia
时间窗: Up to Week 268 (Week 260 in Maintenance Phase)
Numbers of participants with enterochromaffin-like-cell hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.
Number of Participants with G-cell Hyperplasia
时间窗: Up to Week 268 (Week 260 in Maintenance Phase)
Numbers of participants with G-cell hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.
次要结局
未报告次要终点