JPRN-jRCTs031180040已完成4 期
Vonoprazan study in patients with erosive esophagitis to evaluate long-term safety - Vonoprazan study in patients with erosive esophagitis to evaluate long-term safety
Akiyama Junichi0 个研究点目标入组 195 人开始时间: 2018年11月21日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 195
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.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)
- •2.Participants with H. pylori negative
- •3.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.
- •4.Participants who can sign and date an informed consent form and information sheet prior to the conduction of the clinical research procedures.
- •5.Male or female participants aged 20 years or older at the time of informed consent
- •6.Therapeutic category: Ambulatory
- •7.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
- •8.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
- •1.Participants with concurrent peptic ulcer (except scarred stage) or Zollinger-Ellison syndrome
- •2.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)
- •3.Participants with a history of H. pylori eradication.
- •4.Participants who have received surgery or treatment affecting gastroesophageal reflux (fundoplication or dilation for esophageal stenosis [excluding Schatzki's ring], etc.)
- •5.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.
- •6.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).
- •7.Participants with renal impairment or renal failure [creatinine clearance (CCr) <30 mL/min, etc.]
- •8.Participants with a history of hypersensitivity or allergy for PPIs.
- •9.Participants with a history of gastrectomy, gastrointestinal resection, or vagotomy
- •10.Participants with a malignant tumor
- •11.Participants who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant
- •12.Participants with one of the diseases listed under administration contraindication in the vonoprazan or lansoprazole package insert
- •13.Participants planning to take prohibited concomitant medications during the research period
- •14.Participants participating in other clinical studies
- •15.Participants who have been determined to be inappropriate as subjects in the study by the principal investigator or investigator
- •16.Participants who have taken PPIs other than the study drug or the control drug during the healing phase
- •17.Participants who have been determined to be inappropriate as subjects in the study by the principal investigator or investigator
研究者
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