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

NCT07115706 | Not Yet Recruiting

• 1 other identifier: JL-JAQ-403
• Study Type: observational
• Target: 7,150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Erosive Gastroesophageal Reflux Disease

Keywords

Erosive Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

• Change in Reflux Disease Questionnaire (RDQ) at 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.

  Week 8

Study Arms (1)

Group1

those with a condition

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

hospital

You may qualify if:

• 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

You may not qualify if:

• Subjects who fall under the contraindications listed in the precautions for use section of the approved labeling for Fexuclu tablets:
• Subjects with hypersensitivity or a history of hypersensitivity to the investigational drug or any of its components
• Subjects currently taking medications containing atazanavir, nelfinavir, or rilpivirine
• Pregnant women, women who may be pregnant, or breastfeeding women
• 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.

Sponsors & Collaborators

• Jeil Pharmaceutical Co., Ltd.: lead

Central Study Contacts

Minjeong Kim

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08