A Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn

Study Overview
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Brief Summary
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This study aims to compare the nighttime heartburn improvement effect of Tegoprazan 50mg and Esomeprazole 40mg(or 20mg) in patients with GERD.

Detailed Description
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This is a multi-center, double-blind, randomized, active-controlled phase 4 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg or 20mg).

Official Title
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A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Drug: Tegoprazan
* Drug: Esomeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects aged between 19 and 75 years Subjects who have erosive reflux disease or non-erosive reflux disease Exclusion Criteria: Unable to undergo upper GI endoscopy Symptoms of primary or secondary esophageal movement disorders Subjects who have undergone or are scheduled to undergo surgery that can affect gastric acid secretion(e.g. upper gastrectomy, vagotomy, etc)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tegoprazan 50mg<br>Tegoprazan 50mg, once daily, oral administration for two weeks | Drug: Tegoprazan<br>* Tegoprazan 50mg tablet<br>|
| Active Comparator: Esomeprazole 40mg or 20mg<br>In case of ERD patients: Esomeprazole 40mg, qd, oral administration for two weeks In case of NERD patients: Esomeprazole 20mg, qd, oral administration for two weeks | Drug: Esomeprazole<br>* Esomeprazole 20mg tablet For patients with ERD: two Esomeprazole 20mg tablets For patients with NERD: one Esomeprazole 20mg tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of days without nighttime heartburn during the 2-week dosing period | Percentage of days without nighttime heartburn = Number of days without nighttime heartburn symptoms during the dosing period / Number of days when nighttime heartburn was assessed x 100 | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first nighttime hearturn-free interval(days) | Number of days to reach the first day without symptoms of nighttime heartburn after the administration of investigational drug | 2 weeks | 
| Percentage of days without daytime heartburn during the 2-week dosing period | Percentage of days without daytime heartburn = Number of days without daytime heartburn symptoms during the dosing period / Number of days when daytime heartburn was assessed x 100 | 2 weeks |