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

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux
• Interventions: Drug: Vonoprazan; Drug: Esomeprazole

• Registration Number: NCT04720781
• Lead Sponsor: Showa Inan General Hospital

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

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 Timeline

• Study First Submitted: 2021-01-17
• Study First Submitted QC: 2021-01-20
• Study Start: 2021-01-21
• Study First Posted: 2021-01-22
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vonoprazan	Vonoprazan	Vonoprazan (20mg/day) is prescribed for patients with erosive esophagitis
Esomeprazole	Esomeprazole	Esomeprazole (20mg/day) is prescribed for patients with erosive esophagitis

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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%

Trial Locations

Locations (1)

Showa Inan General hospital; 🇯🇵 Komagane, Nagano, Japan