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RecruitingNCT07894939Updated Oct 26, 2026

Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Zastaprazan Citrate

An observational study in Erosive Gastroesophageal Reflux Disease, sponsored by Jeil Pharmaceutical Co., Ltd.. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Jeil Pharmaceutical Co., Ltd. · Observational

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 11 months later.
Updated Oct 26, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Erosive Gastroesophageal Reflux Disease
03

In context

Lead sponsor

Jeil Pharmaceutical Co., Ltd. is the lead sponsor of 37 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Erosive Gastroesophageal Reflux Disease

    Patients administrated zastaprazan citrate

    Drug: zastaprazan citrate

Interventions

  • Drugzastaprazan citrate

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollment to the end of treatment at 8 weeks

07

Study locations

1 of 1 sites recruiting
  • Seoul National University BORAMAE Medical Center
    Seoul, South Korea
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07894939
Responsible party
Sponsor
First posted
Oct 26, 2026
Start date
Nov 2, 2024
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Oct 26, 2026

Study contacts

Project Leader in Jeil Pharmaceutical
Contact
pvsafety@jeilpharm.co.kr
+82-2-549-7451
Ji Wom Kim
principal investigator · SMG-SNU Boramae Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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