Post-marketing check of zastaprazan citrate safety and how well it works in Korean patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational surveillance monitors safety and effectiveness of zastaprazan citrate used according to the approved prescribing information in Korean patients. Data are collected from individuals who have recently been prescribed zastaprazan citrate and provided informed consent. The study excludes those with drug hypersensitivities, pregnancy, lactation, certain concomitant antiretroviral therapies, or specific hereditary lactose-related disorders. Primary focus is on real-world safety signals and clinical effectiveness in erosive gastroesophageal reflux disease. No active intervention beyond standard prescribing practices is involved, and the study is conducted at Seoul National University BORAMAE Medical Center in Seoul.

Why it matters

Who can join: the full rules

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:

* 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.

Where it's running

• Seoul National University BORAMAE Medical Center
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Ji Wom Kim — SMG-SNU Boramae Medical Center
• Study coordinator: Project Leader in Jeil Pharmaceutical
• Email: pvsafety@jeilpharm.co.kr
• Phone: +82-2-549-7451

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.