A Study to Evaluate Tegoprazan as a Diagnostic Tool for GERD

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.

Study Overview

• Status: Not yet recruiting
• Conditions: GERD (Gastroesophageal Reflux Disease)
• Intervention / Treatment: Drug: Tegoprazan 50 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ahrong Kim; Phone Number: +82 31-5176-4666; Email: ahrong.kim@inno-n.com
• Study Contact Backup: Name: Jisu Kim; Phone Number: +82 31-5176-4670; Email: jisu.kim@inno-n.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• Use of any prohibited medications within the specified wash-out periods or requiring continuous use during the study:

  1. Within 2 weeks prior to screening: Acid suppressants (PPIs, P-CABs).
  2. Within 1 week prior to screening: Prokinetics, H2 receptor antagonists, gastric mucosal protectors, antacids, or anticholinergics.
  3. During the study period (continuous use): Corticosteroids, NSAIDs, antithrombotics, anticoagulants, antipsychotics, antidepressants, or anxiolytics.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tegoprazan 50 mg; Tegoprazan 50 mg tablet will be orally administered once daily for 7 days.	Drug: Tegoprazan 50 mg; Tegoprazan 50 mg tablet will be orally administered once daily for 7 days.
Placebo Comparator: Placebo; Placebo tablet will be orally administered once daily for 7 days.	Drug: Placebo; Placebo tablet will be orally administered once daily for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on total symptom score	Day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on individual symptoms of heartburn and acid regurgitation	Day 7
Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on total symptom score	Day 3
Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on individual symptoms of heartburn and acid regurgitation	Day 3
Change from baseline in the 7-day symptom assessment questionnaire score at the end of visit	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	Baseline and Day 7 (End of Visit)
Change from baseline in Gastroesophageal Reflux Disease Questionnaire (GERD-Q) total score at the end of visit	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	Baseline and Day 7 (End of Visit)

Other Outcome Measures

Outcome Measure	Time Frame
Daily sensitivity and specificity of GERD diagnosis	Daily for 7 days

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Principal Investigator: Do Hoon Kim, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: September 13, 2026
• First Submitted That Met QC Criteria: September 13, 2026
• First Posted (Actual): September 17, 2026

Study Record Updates

• Last Update Posted (Actual): September 17, 2026
• Last Update Submitted That Met QC Criteria: September 13, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux; tegoprazan
• Other Study ID Numbers: IN_APA_404

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No