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

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ClinicalTrials.gov Identifier: NCT04720781
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : February 1, 2022
Sponsor:
Information provided by (Responsible Party):
Akira Horiuchi, Showa Inan General Hospital

Study Description
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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
Gastroesophageal Reflux Drug: Vonoprazan Drug: Esomeprazole Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 21, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Esomeprazole
Placebo Comparator: Esomeprazole
Esomeprazole (20mg/day) is prescribed for patients with erosive esophagitis
 Drug: Esomeprazole
esomeprazole (20mg/day)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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%


Other Outcome Measures:
  1. 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%).


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04720781


Contacts
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Contact: Akira Horiuchi, MD 81265822121 ext 3012 horiuchi.akira@sihp.jp

Locations
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Japan
Showa Inan General hospital Recruiting
Komagane, Nagano, Japan, 399-4191
Contact: Akira Horiuchi, M.D.    81265822121 ext 3012    horiuchi.akira@sihp.jp   
Principal Investigator: Akira Horiuchi, M.D.         
Sponsors and Collaborators
Showa Inan General Hospital
More Information
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Responsible Party: Akira Horiuchi, Chief of Digestive Disease Center, Showa Inan General Hospital
ClinicalTrials.gov Identifier: NCT04720781    
Other Study ID Numbers: Revisiting
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: February 1, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action