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

Gastroesophageal Reflux Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04720781
• Other study ID #: Revisiting
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Showa Inan General Hospital
• Contact: Akira Horiuchi, MD
• Phone: 81265822121
• Email: horiuchi.akira[@]sihp.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

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

Locations

Country	Name	City	State
Japan	Showa Inan General hospital	Komagane	Nagano

Sponsors (1)

Lead Sponsor	Collaborator
Showa Inan General Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Questionnaire on satisfaction with taking the medicine at revisiting	The patient's satisfaction is assessed using visual analogue scale (Exellent 100% to very bad 0%).	3months
Primary	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.	3 months
Secondary	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%	3 months