Erosive Gastroesophageal Reflux DiseaseNCT07115706
JAQBO® Tab. 20 mg(Zastaprazan Citrate) in Erosive GERD
An observational study of Erosive Gastroesophageal Reflux Disease, run by Jeil Pharmaceutical Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Erosive Gastroesophageal Reflux Disease
- How many people
- 7,150 participants
- Where
- No sites listed yet
- Study dates
- 25 Aug 2025to 31 Jul 2026
- How long will I take part?
- 8 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hospital
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multi-center Prospective Observational Study to Evaluate the Effectiveness and Safety of JAQBO® Tab. 20 mg(Zastaprazan Citrate) in Erosive Gastroesophageal Reflux Disease
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.
Read the detailed description
Multi-center prospective observational study
- Conditions
- Erosive Gastroesophageal Reflux Disease
- Keywords
- Erosive Gastroesophageal Reflux Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group1 | those with a condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start25 Aug 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 7,150 participants (estimated)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115706
- Sponsor's protocol ID
- JL-JAQ-403
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Prospective Observational Study to Evaluate the Effectiveness and Safety of JAQBO® Tab. 20 mg(Zastaprazan Citrate) in Erosive Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT07115706
- Acronym / sponsor ID
- JL-JAQ-403
- Conditions
- Erosive Gastroesophageal Reflux Disease
- Keywords
- Erosive Gastroesophageal Reflux Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 7,150 participants (estimated)
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group1 | – | –those with a condition |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospital
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- Subjects who fall under the contraindications listed in the precautions for use section of the approved labeling for Fexuclu tablets:
- Subjects deemed inappropriate for participation in the study at the investigator's discretion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Reflux Disease Questionnaire (RDQ) at Week 8
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Erosive Gastroesophageal Reflux Disease
RecruitingObservational study
Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Zastaprazan Citrate
Erosive Gastroesophageal Reflux Disease
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks
Symptomatic Non-erosive Gastroesophageal Reflux Disease
Not yet recruitingPhase 4
PPI Dosing Per CYP2C19 Genotype
Gastroesophageal Reflux Disease With Esophagitis
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn
Recruiting
Neuroregulators for the Treatment of Diseases Associated With Esophageal-brain-gut Axis Communication Abnormalities.
Gut-Brain Disorders, GERD Without Erosive Esophagitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Erosive Gastroesophageal Reflux Disease, run by Jeil Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minjeong Kim (+82 2-549-7451 ext. 542, mjkim1@jeilpharm.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Reflux Disease Questionnaire (RDQ) at Week 8 (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.