JPRN-jRCT1080223099已完成4 期
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)
Akiyama Junichi0 个研究点目标入组 202 人开始时间: 2016年2月8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
- 202
研究概览
简要总结
The incidences of prominence/hyperplasia of wall cells and hyperplasia of G cells were consistently high after the start of the maintenance phase in both groups. The incidence of hyperplasia of crypt epithelial cells was low during the maintenance phase in both groups; however, it tended to be higher in the vonoprazan group than in the lansoprazole group. The incidence of proliferation of endocrine cells was low during the maintenance phase in both groups, but increased at Week 260 of the maintenance phase.
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
- •< At the start of healing phase >
- •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
- •< At the start of maintenance phase >
- •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
- •< At the start of healing phase >
- •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
相似试验
已完成
4 期
Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term SafetyErosive EsophagitisNCT02679508Takeda208
已完成
4 期
VISIOErosive EsophagitisJPRN-jRCTs031180040Akiyama Junichi195
终止
不适用
Effect of Antireflux Therapy on the Expression of Genes in Patients With GERDGERDGastroesophageal RefluxNCT00624546University of Rochester24
Unknown
4 期
Vonoprazan Fumarate in Combination With Amoxicillin for the First-line Eradication of Helicobacter Pylori -- a Multicenter, Randomized, Parallel Controlled StudyHelicobacter Pylori Eradication RateNCT05196945Sixth Affiliated Hospital, Sun Yat-sen University316
已完成
不适用
Impact of esomeprazole and vonoprazan on the antiplatelet effect of clopidogrel and prasugrel, with reference to CYP2C19 genotypesIschemic heart disease and upper gastrointestinal bleeding.JPRN-UMIN000019901The First Department of Medicine and the Center for Clinical Research at Hamamatsu University School of Medicine30