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临床试验/NCT04720781
NCT04720781已完成不适用

The Need of Revisiting to an Outpatient Clinic After the Prescription of Vonoprazan or Esomeprazole for 4weeks for Erosive Esophagitis Without Any Appointments

Showa Inan General Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年1月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
The number of patients who revisit our outpatient clinic after the prescription without any appointments

研究概览

简要总结

After vonoprazan (20mg/day) or esomeprazole (20mg/day) for 4weeks is prescribed for patients with erosive esophagitis diagnosed by esophagogastroduodenoscopy, the number of patients who will visit our outpatient clinic again due to some reasons without any appointments is compared with vonoprazan group and esomeprazole.

详细描述

  1. Patients who have erosive esophagitis diagnosed by esophagogastroduodenoscopy is enrolled.
  2. Vonoprazan (20mg/day) or esomeprazole (20mg/day) is prescribed for 4weeks the patients randomly without next appointments.
  3. Some patients may visit our outpatient clinic again due to some reasons without any appointments.
  4. The number of the patients who revisit our outpatient clinic again is compared with vonoprazan group and esomeprazole.

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
None

入排标准

年龄范围
19 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • outpatients belonging to American Society of Anesthesiologists class I or II
  • patients have erosive esophagitis diagnosed by esophagogastroduodenoscopy shortly before the prescription

排除标准

  • other acid blockers are taken

研究组 & 干预措施

Vonoprazan

Active Comparator

Vonoprazan (20mg/day) is prescribed for patients with erosive esophagitis

干预措施: Vonoprazan (Drug)

Esomeprazole

Placebo Comparator

Esomeprazole (20mg/day) is prescribed for patients with erosive esophagitis

干预措施: Esomeprazole (Drug)

结局指标

主要结局

The number of patients who revisit our outpatient clinic after the prescription without any appointments

时间窗: 3 months

The need to revisit our outpatient clinic again without any appointments may show the patients' satisfaction or dissatisfaction after the prescription of vonoprazan or esomeprazole. The difference in the number between the two groups may show the difference in the effectiveness between the two medicines.

次要结局

  • Change of the main symptom with patients after/before medication when the patients revisit again(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Akira Horiuchi

Chief of Digestive Disease Center

Showa Inan General Hospital

研究点 (1)

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