A Phase 4 interventional study of Tegoprazan 50 mg and Placebo in GERD (Gastroesophageal Reflux Disease), sponsored by HK inno.N Corporation. Not yet recruiting. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by HK inno.N Corporation · Phase 4, Interventional, and Diagnostic
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.
1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
This study's planned enrollment of 100 is above the median of 68 across 796 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →HK inno.N Corporation is the lead sponsor of 102 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Use of any prohibited medications within the specified or requiring continuous use during the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tegoprazan 50 mg tablet will be orally administered once daily for 7 days.
Drug: Tegoprazan 50 mg
Placebo tablet will be orally administered once daily for 7 days.
Drug: Placebo
Tegoprazan 50 mg tablet will be orally administered once daily for 7 days.
Placebo tablet will be orally administered once daily for 7 days.
Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on total symptom score
Time frame: Day 7
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)
Daily sensitivity and specificity of GERD diagnosis
Time frame: Daily for 7 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tegoprazan