GERD (Gastroesophageal Reflux Disease)Phase 4NCT07826455
A Study to Evaluate Tegoprazan as a Diagnostic Tool for GERD
A Phase 4 study testing Tegoprazan 50 mg in people with GERD (Gastroesophageal Reflux Disease), run by HK inno.N Corporation.
Trial summary
The purpose of this study is to evaluate the diagnostic value of tegoprazan for GERD. Patients experiencing typical GERD symptoms, such as heartburn and acid regurgitation, will take either tegoprazan or a placebo once daily for 1 week. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- GERD (Gastroesophageal Reflux Disease)
- What is being tested?
- Tegoprazan 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Jul 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 19 to 75 years who have experienced symptoms of acid regurgitation or heartburn at least twice a week starting at least 3 months prior to screening.
- Baseline Symptom Assessment Questionnaire score of at least 6 at screening.
- 7-Day Symptom Assessment Questionnaire score of at least 4 at randomization.
Who cannot join
- Known hypersensitivity to Potassium-Competitive Acid Blockers (P-CABs) or benzimidazoles.
- Presence of gastrointestinal warning symptoms (e.g., progressive dysphagia, bleeding, unintentional weight loss within 3 months, hematemesis, anemia, hematochezia, or rectal bleeding) without a confirmed negative tumor finding on endoscopy.
- History of or planned gastrointestinal surgery that potentially affects gastric acid secretion.
- Diagnosed with Zollinger-Ellison syndrome or other gastric acid secretion disorders.
- Endoscopic evidence of esophageal stricture, ulcer stenosis, esophageal varices, Barrett's esophagus (> 3 cm), eosinophilic esophagitis, gastrointestinal bleeding, active peptic ulcer, or malignant tumor.
- Clinically significant hepatic or renal impairment (AST, ALT, ALP, GGT, total bilirubin, and creatinine greater than or equal to 2 times the upper limit of normal [ULN]) at Screening.
Show all 10Show fewer
- Use of any prohibited medications within the specified wash-out periods or requiring continuous use during the study:
- Within 2 weeks prior to screening: Acid suppressants (PPIs, P-CABs).
- Within 1 week prior to screening: Prokinetics, H2 receptor antagonists, gastric mucosal protectors, antacids, or anticholinergics.
- During the study period (continuous use): Corticosteroids, NSAIDs, antithrombotics, anticoagulants, antipsychotics, antidepressants, or anxiolytics.
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: Diagnostic Value of Early Response to Tegoprazan in Symptomatic GERD Patients: An Exploratory Clinical Study
The purpose of this study is to evaluate the diagnostic value of tegoprazan for GERD.
Patients experiencing typical GERD symptoms, such as heartburn and acid regurgitation, will take either tegoprazan or a placebo once daily for 1 week.
Investigators will compare the short-term symptom improvement between the two groups to determine if an early response to tegoprazan can help diagnose GERD.
- Conditions
- GERD (Gastroesophageal Reflux Disease)
- Being tested
- Tegoprazan 50 mg, Placebo
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegoprazan 50 mgDrug
Tegoprazan 50 mg tablet will be orally administered once daily for 7 days.
PlaceboDrug
Placebo tablet will be orally administered once daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Tegoprazan 50 mg | Experimental | Tegoprazan 50 mg tablet will be orally administered once daily for 7 days. Receives: Drug: Tegoprazan 50 mg |
| Placebo | Placebo comparator | Placebo tablet will be orally administered once daily for 7 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on total symptom score
Measured: Day 7
Secondary outcomes (7)
Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on individual symptoms of heartburn and acid regurgitation
Measured: Day 7
Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on total symptom score
Measured: Day 3
Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on individual symptoms of heartburn and acid regurgitation
Measured: Day 3
Change from baseline in the 7-day symptom assessment questionnaire score at the end of visit
Measured: Baseline and Day 7 (End of Visit)
Percentage of patients based on baseline Hospital Anxiety and Depression Scale (HADS) score strata, compared by GERD diagnosis
Measured: Baseline and Day 7 (End of Visit)
Change from baseline in Gastroesophageal Reflux Disease Questionnaire (GERD-Q) total score at the end of visit
Measured: Baseline and Day 7 (End of Visit)
Change from baseline in Self-Evaluation Questionnaire for dyspepsia (SEQ-DYSPEPSIA) total score at the end of visit
Measured: Baseline and Day 7 (End of Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERD (Gastroesophageal Reflux Disease)Studies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Do Hoon Kim, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826455
- Sponsor's protocol ID
- IN_APA_404
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 17 Sep 2026
- 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Early Response to Tegoprazan in Symptomatic GERD Patients: An Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT07826455
- Acronym / sponsor ID
- IN_APA_404
- Conditions
- GERD (Gastroesophageal Reflux Disease)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 17 Sep 2026 (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 diagnostic value of tegoprazan for GERD.
Patients experiencing typical GERD symptoms, such as heartburn and acid regurgitation, will take either tegoprazan or a placebo once daily for 1 week.
Investigators will compare the short-term symptom improvement between the two groups to determine if an early response to tegoprazan can help diagnose GERD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tegoprazan 50 mg | Experimental | Drug: Tegoprazan 50 mgTegoprazan 50 mg tablet will be orally administered once daily for 7 days. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet will be orally administered once daily for 7 days. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 19 to 75 years who have experienced symptoms of acid regurgitation or heartburn at least twice a week starting at least 3 months prior to screening.
- Baseline Symptom Assessment Questionnaire score of at least 6 at screening.
- 7-Day Symptom Assessment Questionnaire score of at least 4 at randomization.
Key exclusion criteria (10 listed)
- Known hypersensitivity to Potassium-Competitive Acid Blockers (P-CABs) or benzimidazoles.
- Presence of gastrointestinal warning symptoms (e.g., progressive dysphagia, bleeding, unintentional weight loss within 3 months, hematemesis, anemia, hematochezia, or rectal bleeding) without a confirmed negative tumor finding on endoscopy.
- History of or planned gastrointestinal surgery that potentially affects gastric acid secretion.
- Diagnosed with Zollinger-Ellison syndrome or other gastric acid secretion disorders.
- Endoscopic evidence of esophageal stricture, ulcer stenosis, esophageal varices, Barrett's esophagus (> 3 cm), eosinophilic esophagitis, gastrointestinal bleeding, active peptic ulcer, or malignant tumor.
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 |
|---|---|---|
| Tegoprazan 50 mgTegoprazan 50 mg tablet will be orally administered once daily for 7 days. | Drug | Tegoprazan 50 mg |
| PlaceboPlacebo tablet will be orally administered once daily for 7 days. | Drug | Placebo |
Primary outcome
Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on total symptom score
Time frame: Day 7
7 secondary outcomes
Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on individual symptoms of heartburn and acid regurgitation
Time frame: Day 7
Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on total symptom score
Time frame: Day 3
Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on individual symptoms of heartburn and acid regurgitation
Time frame: Day 3
Change from baseline in the 7-day symptom assessment questionnaire score at the end of visit
Time frame: Baseline and Day 7 (End of Visit)
Percentage of patients based on baseline Hospital Anxiety and Depression Scale (HADS) score strata, compared by GERD diagnosis
Time frame: Baseline and Day 7 (End of Visit)
Change from baseline in Gastroesophageal Reflux Disease Questionnaire (GERD-Q) total score at the end of visit
Time frame: Baseline and Day 7 (End of Visit)
Change from baseline in Self-Evaluation Questionnaire for dyspepsia (SEQ-DYSPEPSIA) total score at the end of visit
Time frame: Baseline and Day 7 (End of Visit)
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 17 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for GERD (Gastroesophageal Reflux Disease)
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
RecruitingObservational study
Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Zastaprazan Citrate
Erosive Gastroesophageal Reflux Disease
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Recruiting
Phrenoesophageal Ligament Reconstruction With Mesh
Hiatus Hernia, Gastreoesophageal Reflux Disease
Enrolling by invitation
Endoscopic Treatment of Gastroesophageal Reflux Disease
Gastro Esophageal Reflux Disease
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.
Do Hoon Kim principal investigator
Asan Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tegoprazan 50 mg in people with GERD (Gastroesophageal Reflux Disease), run by HK inno.N Corporation.
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 3 inclusion and 10 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 17 Sep 2026. 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. Some participants in this study may receive a placebo. 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 Jisu Kim (+82 31-5176-4670, jisu.kim@inno-n.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on total symptom score (time frame: Day 7). 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 17 Sep 2026.