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

Not yet recruiting

• Conditions: Erosive Gastroesophageal Reflux Disease

• Registration Number: NCT07115706
• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.

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

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-04
• Study First Submitted QC: 2025-08-04
• Study First Posted: 2025-08-11
• Last Update Submitted: 2025-08-11
• Last Update Posted: 2025-08-14
• Study Start: 2025-08-25
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 7150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.