GERDPhase 4GERDNCT07268820
Heartburn, Gastroesophageal Reflux Disease
A Phase 4 study testing Zastaprazan and Esomeprazole in people with GERD, run by Incheon St.Mary's Hospital at 10 sites in South Korea.
Trial summary
Gastroesophageal reflux disease (GERD) is a condition caused by the reflux of stomach contents into the esophagus, presenting with typical symptoms such as heartburn and acid regurgitation. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- GERD
- What is being tested?
- Zastaprazan and Esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 7 Jul 2025to 30 Sep 2026
- Phase
- Phase 4
- 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
Who may be able to join
- Korean adults aged 19 years or older as of the date of written consent
- Those diagnosed with erosive gastroesophageal reflux disease based on upper gastrointestinal endoscopy (EGD)
- Those who reported nighttime heartburn for more than 3 months at the time of screening (Visit 1)
- Those who voluntarily decided to participate and provide written informed consent
Who cannot join
- Those who cannot undergo upper gastrointestinal endoscopy (EGD)
- Individuals with a history of drug or alcohol abuse (within the past year)
- Individuals who have received other investigational products within one month prior to the screening visit (Visit 1)
- In addition to the above, individuals with clinically significant findings that the investigator deems medically inappropriate for the present study
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
South Korea10 sites, 10 recruiting
- Recruiting
Korea University Ansan Hospital
Ansan
- Recruiting
Pusan National University Hospital
Busan
- Recruiting
Kyungpook National University Chilgok Hospital
Chilgok
- Recruiting
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon
- Recruiting
Chonnam National University Hospital
Gwangju
- Recruiting
Catholic University of Korea, Incheon ST. Mary's Hospital
Incheon
Byung-Wook Kim, 82-2-1544-9004, gastro@catholic.ac.kr
- Recruiting
Gangnam Severance Hospital
Seoul
- Recruiting
Kyung Hee University Hospital
Seoul
- Recruiting
Soonchunhyang University Hospital
Seoul
- Recruiting
Pusan National University Yangsan Hospital
Yangsan
About this study
Official title: A Multicenter, Double-blind, Randomized, Investigator-initiated Trial to Evaluate the Degree of Symptom Relief of Zastaprazan and Esomeprazole in Patients With Erosive Reflux Disease With Night-time Heartburn Symptoms
Gastroesophageal reflux disease (GERD) is a condition caused by the reflux of stomach contents into the esophagus, presenting with typical symptoms such as heartburn and acid regurgitation.
GERD is a chronic condition that affects quality of life, and patients with this condition are known to have a lower quality of life compared to healthy individuals. In particular, nocturnal heartburn can lead to sleep deprivation and affect daily life, as well as overall quality of life.
This study aims to evaluate the efficacy of alleviating nocturnal heartburn symptoms in patients with erosive reflux disease (ERD).
Read the detailed description
This multicenter, double-blind, randomized, active-controlled Phase 4 study aims to exploratorily evaluate the comparative effects and safety of zastaprazan 20 mg and esomeprazole 40 mg in subjects with gastroesophageal reflux disease.
- Conditions
- GERD
- Being tested
- Zastaprazan, Esomeprazole
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZastaprazanDrug
Also called P-CAB
Participants in this arm will receive zastaprazan. This group serves as the experimental treatment group exploratorily evaluating drug for GERD.
EsomeprazoleDrug
Also called PPI
Participants in this arm will receive esomeprazole. This group serves as the active comparator treatment group exploratorily evaluating drug for GERD.
| Study group | Role | What they receive |
|---|---|---|
| Zastaprazan | Experimental | Zastaprazan 20 mg, once daily, preferably administered orally in the morning before breakfast for four weeks Receives: Drug: Zastaprazan |
| Esomeprazole | Active comparator | Esomeprazole 40 mg, once daily, preferably administered orally in the morning before breakfast for four weeks Receives: Drug: Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants without sleep disturbance related to nighttime heartburn during the last 7 days
This measure is based on participant-reported information collected by subject diary during the study and reflects whether sleep disturbance related to heartburn was noted over the period evaluated. Symptom severity ranges from 0 to 4, with higher scores indicating worse sleep disturbance.
Measured: Week 2
Secondary outcomes (4)
Proportion of participants without sleep disturbance related to nighttime heartburn during the last 7 days
This measure is based on participant-reported information collected by subject diary during the study and reflects whether sleep disturbance related to heartburn was noted over the period evaluated. Symptom severity ranges from 0 to 4, with higher scores indicating worse sleep disturbance.
Measured: Week 4
Mean change from baseline in Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score
The change from baseline in GERD-HRQL scores, evaluated at Weeks 2 and 4 during the treatment period. The GERD-HRQL uses item scores ranging from 0 to 5, with higher scores indicating more severe symptoms.
Measured: Baseline, Week 2, Week 4
Mean change from baseline in Gastrointestinal Symptom Rating Scale (GSRS) score
The GSRS assesses gastrointestinal symptoms across multiple domains, with each item scored on a 1 to 7 scale, where higher scores indicate more severe symptoms.
Measured: Baseline, Week 2, Week 4
Change from baseline in Gastroesophageal Reflux Disease Questionnaire (GerdQ) score
The GerdQ evaluates symptoms using ordinal item scores; for heartburn and acid regurgitation items, higher scores indicate more frequent symptoms; each item is scored on a 0 to 3 scale based on symptom frequency over the previous week, with reverse scoring applied to upper stomach pain and nausea items.
Measured: Baseline, Week 2, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start7 Jul 2025
- Primary completion29 May 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incheon St.Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byung-Wook Kim, Incheon St.Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268820
- Sponsor's protocol ID
- JL-JAQ-402
- Acronym
- GERD
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Investigator-initiated Trial to Evaluate the Degree of Symptom Relief of Zastaprazan and Esomeprazole in Patients With Erosive Reflux Disease With Night-time Heartburn Symptoms
- ClinicalTrials.gov ID
- NCT07268820
- Acronym / sponsor ID
- GERD / JL-JAQ-402
- Conditions
- GERD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Incheon St.Mary's HospitalUniversity, hospital or other
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 29 May 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 8 Dec 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.
Gastroesophageal reflux disease (GERD) is a condition caused by the reflux of stomach contents into the esophagus, presenting with typical symptoms such as heartburn and acid regurgitation.
GERD is a chronic condition that affects quality of life, and patients with this condition are known to have a lower quality of life compared to healthy individuals. In particular, nocturnal heartburn can lead to sleep deprivation and affect daily life, as well as overall quality of life.
This study aims to evaluate the efficacy of alleviating nocturnal heartburn symptoms in patients with erosive reflux disease (ERD).
Detailed description
This multicenter, double-blind, randomized, active-controlled Phase 4 study aims to exploratorily evaluate the comparative effects and safety of zastaprazan 20 mg and esomeprazole 40 mg in subjects with gastroesophageal reflux disease.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zastaprazan | Experimental | Drug: ZastaprazanZastaprazan 20 mg, once daily, preferably administered orally in the morning before breakfast for four weeks |
| Esomeprazole | Active comparator | Drug: EsomeprazoleEsomeprazole 40 mg, once daily, preferably administered orally in the morning before breakfast for four weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Korean adults aged 19 years or older as of the date of written consent
- Those diagnosed with erosive gastroesophageal reflux disease based on upper gastrointestinal endoscopy (EGD)
- Those who reported nighttime heartburn for more than 3 months at the time of screening (Visit 1)
- Those who voluntarily decided to participate and provide written informed consent
Key exclusion criteria (4 listed)
- Those who cannot undergo upper gastrointestinal endoscopy (EGD)
- Individuals with a history of drug or alcohol abuse (within the past year)
- Individuals who have received other investigational products within one month prior to the screening visit (Visit 1)
- In addition to the above, individuals with clinically significant findings that the investigator deems medically inappropriate for the present study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZastaprazanAlso: P-CABParticipants in this arm will receive zastaprazan. This group serves as the experimental treatment group exploratorily evaluating drug for GERD. | Drug | Zastaprazan |
| EsomeprazoleAlso: PPIParticipants in this arm will receive esomeprazole. This group serves as the active comparator treatment group exploratorily evaluating drug for GERD. | Drug | Esomeprazole |
Primary outcome
Proportion of participants without sleep disturbance related to nighttime heartburn during the last 7 days
Time frame: Week 2
This measure is based on participant-reported information collected by subject diary during the study and reflects whether sleep disturbance related to heartburn was noted over the period evaluated. Symptom severity ranges from 0 to 4, with higher scores indicating worse sleep disturbance.
4 secondary outcomes
Proportion of participants without sleep disturbance related to nighttime heartburn during the last 7 days
Time frame: Week 4
Mean change from baseline in Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score
Time frame: Baseline, Week 2, Week 4
Mean change from baseline in Gastrointestinal Symptom Rating Scale (GSRS) score
Time frame: Baseline, Week 2, Week 4
Change from baseline in Gastroesophageal Reflux Disease Questionnaire (GerdQ) score
Time frame: Baseline, Week 2, Week 4
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 23 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for GERD
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Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
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Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zastaprazan and Esomeprazole in people with GERD, run by Incheon St.Mary's Hospital at 10 sites 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Byung-Wook Kim (+82-1544-9004, gastro@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants without sleep disturbance related to nighttime heartburn during the last 7 days (time frame: Week 2). 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 23 Dec 2025.