Erosive Reflux DiseaseNCT06952855
Observationa Study is a Prospective and Multi-institutional Observational Study.
An observational study of Erosive Reflux Disease and Heartburn, run by Jeil Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This observational study is a prospective, multi-institutional non intervention study to examine the prescription patterns, corresponding treatment effects and safety in routine clinical practice for patients prescribed for the treatment of gastroesophageal reflux disease. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Erosive Reflux Disease, Heartburn, Acid Regurgitation
- How many people
- 5,536 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2024to 23 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: GERD patients
Who may be able to join
- An adult over 19 years of age
- A person who voluntarily provides written informed consent
Who cannot join
- A pregnant woman or a nursing woman
- A person who is deemed unsuitable for the subject of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study to Evaluate Effectiveness, Safety and Satisfaction Level of Zastaprazan (JAQBO®) Under Daily Treatment for Patients With Erosive Gastroesophageal Reflux Disease
This observational study is a prospective, multi-institutional non intervention study to examine the prescription patterns, corresponding treatment effects and safety in routine clinical practice for patients prescribed for the treatment of gastroesophageal reflux disease.
Read the detailed description
The present observational study is designed to check effect and safety for patients who have been prescribed JAQBO for the treatment of erosive gastroesophageal reflux disease.
- Conditions
- Erosive Reflux Disease, Heartburn, Acid Regurgitation
- Keywords
- GERD, ERD
- Medical subject headings
- Heartburn, Gastroesophageal Reflux
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 |
|---|---|---|
| 1 cohort | No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GERD (heartburn, acid regurgitation) score in RDQ
Scale(none / 1day / 2day/ 3-4 day / 5-6 day/ every day)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Nov 2024
- Primary completion23 Apr 2025
- Study completion23 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive 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
- Other
- Time perspective
- Prospective
- Enrolment
- 5,536 participants (actual)
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
- NCT06952855
- Sponsor's protocol ID
- JL-JAQ-401
- Status last verified
- May 2025
- First submitted
- 11 Mar 2025
- Last updated
- 13 May 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 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate Effectiveness, Safety and Satisfaction Level of Zastaprazan (JAQBO®) Under Daily Treatment for Patients With Erosive Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT06952855
- Acronym / sponsor ID
- JL-JAQ-401
- Conditions
- Erosive Reflux Disease, Heartburn, Acid Regurgitation
- Keywords
- GERD, ERD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,536 participants (actual)
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 23 Apr 2025 (actual)
- First posted
- 1 May 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.
This observational study is a prospective, multi-institutional non intervention study to examine the prescription patterns, corresponding treatment effects and safety in routine clinical practice for patients prescribed for the treatment of gastroesophageal reflux disease.
Detailed description
The present observational study is designed to check effect and safety for patients who have been prescribed JAQBO for the treatment of erosive gastroesophageal reflux disease.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 cohort | – | –No interventions |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- GERD patients
Key inclusion criteria (2 listed)
- An adult over 19 years of age
- A person who voluntarily provides written informed consent
Key exclusion criteria (2 listed)
- A pregnant woman or a nursing woman
- A person who is deemed unsuitable for the subject of the study
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 GERD (heartburn, acid regurgitation) score in RDQ
Time frame: 4 weeks
Scale(none / 1day / 2day/ 3-4 day / 5-6 day/ every day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Erosive Reflux Disease
RecruitingObservational study
Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Zastaprazan Citrate
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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
Cognitive-behavioral Therapy for the 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erosive Reflux Disease and Heartburn, run by Jeil Pharmaceutical Co., Ltd. at 1 site in South Korea.
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 2 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: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GERD (heartburn, acid regurgitation) score in RDQ (time frame: 4 weeks). 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 13 May 2025.