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The Need of Revisiting to an Outpatient Clinic After the Prescription of Vonoprazan or Esomeprazole

Primary Purpose

Gastroesophageal Reflux

Status
Recruiting
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Vonoprazan
Esomeprazole
Sponsored by
Showa Inan General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux

Eligibility Criteria

19 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • other acid blockers are taken

Sites / Locations

  • Showa Inan General hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vonoprazan

Esomeprazole

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change of the main symptom with patients after/before medication when the patients revisit again
The ratio of the degree of the main symptom after/before taking the medicine Good 0%- Bad 100%

Full Information

First Posted
January 17, 2021
Last Updated
April 10, 2023
Sponsor
Showa Inan General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04720781
Brief Title
The Need of Revisiting to an Outpatient Clinic After the Prescription of Vonoprazan or Esomeprazole
Official Title
The Need of Revisiting to an Outpatient Clinic After the Prescription of Vonoprazan or Esomeprazole for 4weeks for Erosive Esophagitis Without Any Appointments
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Showa Inan General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vonoprazan
Arm Type
Active Comparator
Arm Description
Vonoprazan (20mg/day) is prescribed for patients with erosive esophagitis
Arm Title
Esomeprazole
Arm Type
Placebo Comparator
Arm Description
Esomeprazole (20mg/day) is prescribed for patients with erosive esophagitis
Intervention Type
Drug
Intervention Name(s)
Vonoprazan
Other Intervention Name(s)
Esomeprazole
Intervention Description
Vonoprazan (20mg/day) is prescribed for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Intervention Description
esomeprazole (20mg/day)
Primary Outcome Measure Information:
Title
The number of patients who revisit our outpatient clinic after the prescription without any appointments
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change of the main symptom with patients after/before medication when the patients revisit again
Description
The ratio of the degree of the main symptom after/before taking the medicine Good 0%- Bad 100%
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Questionnaire on satisfaction with taking the medicine at revisiting
Description
The patient's satisfaction is assessed using visual analogue scale (Exellent 100% to very bad 0%).
Time Frame
3months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: outpatients belonging to American Society of Anesthesiologists class I or II patients have erosive esophagitis diagnosed by esophagogastroduodenoscopy shortly before the prescription Exclusion Criteria: other acid blockers are taken
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Akira Horiuchi, MD
Phone
81265822121
Ext
3012
Email
horiuchi.akira@sihp.jp
Facility Information:
Facility Name
Showa Inan General hospital
City
Komagane
State/Province
Nagano
ZIP/Postal Code
399-4191
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akira Horiuchi, M.D.
Phone
81265822121
Ext
3012
Email
horiuchi.akira@sihp.jp
First Name & Middle Initial & Last Name & Degree
Akira Horiuchi, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Need of Revisiting to an Outpatient Clinic After the Prescription of Vonoprazan or Esomeprazole

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