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

February 22, 2024 updated by: Akira Horiuchi, Showa Inan General Hospital

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

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.

Study Overview

Status

Recruiting

Detailed Description

  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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Nagano
      • Komagane, Nagano, Japan, 399-4191
        • Recruiting
        • Showa Inan General Hospital
        • Contact:
        • Principal Investigator:
          • Akira Horiuchi, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vonoprazan
Vonoprazan (20mg/day) is prescribed for patients with erosive esophagitis
Vonoprazan (20mg/day) is prescribed for 4 weeks.
Other Names:
  • Esomeprazole
Placebo Comparator: Esomeprazole
Esomeprazole (20mg/day) is prescribed for patients with erosive esophagitis
esomeprazole (20mg/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of patients who revisit our outpatient clinic after the prescription without any appointments
Time Frame: 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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the main symptom with patients after/before medication when the patients revisit again
Time Frame: 3 months
The ratio of the degree of the main symptom after/before taking the medicine Good 0%- Bad 100%
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire on satisfaction with taking the medicine at revisiting
Time Frame: 3months
The patient's satisfaction is assessed using visual analogue scale (Exellent 100% to very bad 0%).
3months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 17, 2021

First Submitted That Met QC Criteria

January 20, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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