Gastroesophageal RefluxNCT04720781
The Need of Revisiting to an Outpatient Clinic After the Prescription of Vonoprazan or Esomeprazole
A study testing Vonoprazan and Esomeprazole in people with Gastroesophageal Reflux, run by Showa Inan General Hospital at 1 site in Japan.
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… Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Vonoprazan and Esomeprazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteJapan
- Study dates
- 21 Jan 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- outpatients belonging to American Society of Anesthesiologists class I or II
- patients have erosive esophagitis diagnosed by esophagogastroduodenoscopy shortly before the prescription
Who cannot join
- other acid blockers are taken
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Vonoprazan, Esomeprazole
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoprazanDrug
Also called Esomeprazole
Vonoprazan (20mg/day) is prescribed for 4 weeks.
EsomeprazoleDrug
esomeprazole (20mg/day)
| Study group | Role | What they receive |
|---|---|---|
| Vonoprazan | Active comparator | Vonoprazan (20mg/day) is prescribed for patients with erosive esophagitis Receives: Drug: Vonoprazan |
| Esomeprazole | Placebo comparator | Esomeprazole (20mg/day) is prescribed for patients with erosive esophagitis Receives: Drug: Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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%
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start21 Jan 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Showa Inan General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akira Horiuchi, Showa Inan General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720781
- Sponsor's protocol ID
- Revisiting
- Status last verified
- May 2025
- First submitted
- 17 Jan 2021
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04720781
- Acronym / sponsor ID
- Revisiting
- Conditions
- Gastroesophageal Reflux
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Showa Inan General HospitalUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vonoprazan | Active comparator | Drug: VonoprazanVonoprazan (20mg/day) is prescribed for patients with erosive esophagitis |
| Esomeprazole | Placebo comparator | Drug: EsomeprazoleEsomeprazole (20mg/day) is prescribed for patients with erosive esophagitis |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- outpatients belonging to American Society of Anesthesiologists class I or II
- patients have erosive esophagitis diagnosed by esophagogastroduodenoscopy shortly before the prescription
Key exclusion criteria (1 listed)
- other acid blockers are taken
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VonoprazanAlso: EsomeprazoleVonoprazan (20mg/day) is prescribed for 4 weeks. | Drug | Vonoprazan |
| Esomeprazoleesomeprazole (20mg/day) | Drug | Esomeprazole |
Primary outcome
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.
1 secondary outcome
Change of the main symptom with patients after/before medication when the patients revisit again
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vonoprazan and Esomeprazole in people with Gastroesophageal Reflux, run by Showa Inan General Hospital at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients who revisit our outpatient clinic after the prescription without any appointments (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.