Erosive Gastroesophageal Reflux DiseaseNCT07894939
Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Zastaprazan Citrate
An observational study of Erosive Gastroesophageal Reflux Disease, run by Jeil Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This post-marketing surveillance aims to evaluate the safety and effectiveness of zastaprazan citrate administered in Korean patients receiving the drug in accordance with the approved prescribing information. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Erosive Gastroesophageal Reflux Disease
- What is being tested?
- zastaprazan citrate
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Nov 2024to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include patients aged 19 years or older who receive their first prescription for zastaprazan citrate in accordance with the approved prescribing information at participating study sites in South Korea. The first prescription must be issued after execution of the study agreement with the respective site. Eligible patients who provide written informed consent will be enrolled consecutively.
Who may be able to join
- Patients who receive their first prescription for zastaprazan citrate in accordance with the approved prescribing information after execution of the study agreement
- Patients who have received an explanation of the study and voluntarily signed the informed consent form.
Who cannot join
- Patients with hypersensitivity or a history of hypersensitivity to zastaprazan citrate or any component of the product.
- atients currently receiving products containing atazanavir, nelfinavir, or rilpivirine.
- Patients who are pregnant or breastfeeding.
- Patients with hereditary disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. This exclusion criterion does not apply to the orally disintegrating tablet formulation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University BORAMAE Medical Center
Seoul
About this study
This post-marketing surveillance aims to evaluate the safety and effectiveness of zastaprazan citrate administered in Korean patients receiving the drug in accordance with the approved prescribing information.
- Conditions
- Erosive Gastroesophageal Reflux Disease
- Being tested
- zastaprazan citrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zastaprazan citrateDrug
There is no treatment allocation in this study. Patients who are prescribed zastaprazan citrate at the discretion of their treating physicians will be enrolled consecutively. Zastaprazan citrate will be administered in accordance with the approved prescribing information.
| Study group | Role | What they receive |
|---|---|---|
| Erosive Gastroesophageal Reflux Disease | Patients administrated zastaprazan citrate Receives: Drug: zastaprazan citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events
The percentage of participants who experience at least one adverse event during the observation period will be calculated. Adverse events will be assessed for seriousness, expectedness based on the approved prescribing information, and causal relationship to zastaprazan citrate. This assessment will identify serious and non-serious adverse drug reactions, including known and unexpected reactions. Events relevant to the safety concerns specified in the risk management plan will also be reviewed.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start2 Nov 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive Gastroesophageal Reflux DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ji Wom Kim, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894939
- Sponsor's protocol ID
- PMS_JP1366_01
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Zastaprazan Citrate
- ClinicalTrials.gov ID
- NCT07894939
- Acronym / sponsor ID
- PMS_JP1366_01
- Conditions
- Erosive Gastroesophageal Reflux Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 26 Oct 2026 (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.
This post-marketing surveillance aims to evaluate the safety and effectiveness of zastaprazan citrate administered in Korean patients receiving the drug in accordance with the approved prescribing information.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erosive Gastroesophageal Reflux Disease | – | Drug: zastaprazan citratePatients administrated zastaprazan citrate |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients aged 19 years or older who receive their first prescription for zastaprazan citrate in accordance with the approved prescribing information at participating study sites in South Korea. The first prescription must be issued after execution of the study agreement with the respective site. Eligible patients who provide written informed consent will be enrolled consecutively.
Key inclusion criteria (2 listed)
- Patients who receive their first prescription for zastaprazan citrate in accordance with the approved prescribing information after execution of the study agreement
- Patients who have received an explanation of the study and voluntarily signed the informed consent form.
Key exclusion criteria (4 listed)
- Patients with hypersensitivity or a history of hypersensitivity to zastaprazan citrate or any component of the product.
- atients currently receiving products containing atazanavir, nelfinavir, or rilpivirine.
- Patients who are pregnant or breastfeeding.
- Patients with hereditary disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. This exclusion criterion does not apply to the orally disintegrating tablet formulation.
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 |
|---|---|---|
| zastaprazan citrateThere is no treatment allocation in this study. Patients who are prescribed zastaprazan citrate at the discretion of their treating physicians will be enrolled consecutively. Zastaprazan citrate will be administered in accordance with the approved prescribing information. | Drug | Erosive Gastroesophageal Reflux Disease |
Primary outcome
Percentage of Participants With Adverse Events
Time frame: From enrollment to the end of treatment at 8 weeks
The percentage of participants who experience at least one adverse event during the observation period will be calculated. Adverse events will be assessed for seriousness, expectedness based on the approved prescribing information, and causal relationship to zastaprazan citrate. This assessment will identify serious and non-serious adverse drug reactions, including known and unexpected reactions. Events relevant to the safety concerns specified in the risk management plan will also be reviewed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- 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.
Ji Wom Kim principal investigator
SMG-SNU Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erosive Gastroesophageal Reflux Disease, run by Jeil Pharmaceutical Co., Ltd. at 1 site in South Korea.
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 4 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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 South Korea. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Project Leader in Jeil Pharmaceutical (+82-2-549-7451, pvsafety@jeilpharm.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Adverse Events (time frame: From enrollment to the end of treatment at 8 weeks). 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 26 Oct 2026.