JAQBO® Tab. 20 mg(Zastaprazan Citrate) in Erosive GERD

A Multi-center Prospective Observational Study to Evaluate the Effectiveness and Safety of JAQBO® Tab. 20 mg(Zastaprazan Citrate) in Erosive Gastroesophageal Reflux Disease

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07115706

Enrollment

7150

Registered

2025-08-11

Start date

2025-08-25

Completion date

2026-07-31

Last updated

2025-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erosive Gastroesophageal Reflux Disease

Keywords

Erosive Gastroesophageal Reflux Disease

Brief summary

The purpose of this study is to evaluate the effectiveness and safety of JAQBO® Tab. 20 mg(Zastaprazan citrate) patients who have been prescribed the investigational drug.

Detailed description

Multi-center prospective observational study

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* subjects aged 19 years or older who have been diagnosed with erosive reflux disease (ERD) * subjects who have voluntarily decided to participate in this observational study and have provided written informed consent after receiving the study information and consent form

Exclusion criteria

* Subjects who fall under the contraindications listed in the precautions for use section of the approved labeling for Fexuclu tablets: 1. Subjects with hypersensitivity or a history of hypersensitivity to the investigational drug or any of its components 2. Subjects currently taking medications containing atazanavir, nelfinavir, or rilpivirine 3. Pregnant women, women who may be pregnant, or breastfeeding women 4. Subjects with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption * Subjects deemed inappropriate for participation in the study at the investigator's discretion.

Design outcomes

Primary

Measure	Time frame	Description
Change in Reflux Disease Questionnaire (RDQ) at Week 8	Week 8	This questionnaire is a self-reported instrument designed to assess the main symptoms of gastroesophageal reflux disease (GERD), including heartburn, acid regurgitation, and dyspepsia. It consists of a total of 12 items, each evaluating the frequency and severity of symptoms using a 6-point scale (0 to 5). In this observational study, only heartburn and acid regurgitation symptoms are assessed. The questionnaire is completed by the study participants themselves, and higher total scores indicate more severe symptoms.

Contacts

Primary ContactMinjeong Kim

mjkim1@jeilpharm.co.kr+82 2-549-7451

Outcome results