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

Sponsor
Showa Inan General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04720781
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
19.3
Anticipated Duration (Months)
15.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 21, 2021
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Vonoprazan

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

Drug: Vonoprazan
Vonoprazan (20mg/day) is prescribed for 4 weeks.
Other Names:
  • Esomeprazole

    		•
    Placebo Comparator: Esomeprazole

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

    Drug: Esomeprazole
    esomeprazole (20mg/day)

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Change of the main symptom with patients after/before medication when the patients revisit again [3 months]

      The ratio of the degree of the main symptom after/before taking the medicine Good 0%- Bad 100%

    Other Outcome Measures

    1. Questionnaire on satisfaction with taking the medicine at revisiting [3months]

      The patient's satisfaction is assessed using visual analogue scale (Exellent 100% to very bad 0%).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Showa Inan General hospital Komagane Nagano Japan 399-4191

    Sponsors and Collaborators

    • Showa Inan General Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Akira Horiuchi, Chief of Digestive Disease Center, Showa Inan General Hospital
    ClinicalTrials.gov Identifier:
    NCT04720781
    Other Study ID Numbers:
    • Revisiting
    First Posted:
    Jan 22, 2021
    Last Update Posted:
    May 5, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Gastroesophageal Reflux
    Esomeprazole

    Study Results

    No Results Posted as of May 5, 2022