- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04720781
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
Conditions
Intervention / Treatment
Detailed Description
- Patients who have erosive esophagitis diagnosed by esophagogastroduodenoscopy is enrolled.
- Vonoprazan (20mg/day) or esomeprazole (20mg/day) is prescribed for 4weeks the patients randomly without next appointments.
- Some patients may visit our outpatient clinic again due to some reasons without any appointments.
- 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
- Name: Akira Horiuchi, MD
- Phone Number: 3012 81265822121
- Email: horiuchi.akira@sihp.jp
Study Locations
-
-
Nagano
-
Komagane, Nagano, Japan, 399-4191
- Recruiting
- Showa Inan General Hospital
-
Contact:
- Akira Horiuchi, M.D.
- Phone Number: 3012 81265822121
- Email: horiuchi.akira@sihp.jp
-
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:
|
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Revisiting
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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