Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Reflux Disease

Study Overview
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Brief Summary
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This study is designed to evaluate the efficacy and safety of Tegoprazan 50mg, compared to Lansoprazole 30mg in patients with healed erosive reflux disease confirmed by endoscopy following oral administration once daily(QD) of 2 weeks or 4 weeks.

Detailed Description
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This is a double blind, radomized, active-controlled, phase 4 study. Subjects will be randomly assigned to one of the two treatment groups (Tegoprazan 50mg, Lansoprazole 30mg)

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 Patients With Erosive Reflux Disease

Conditions
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Erosive Reflux Disease

Intervention / Treatment
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* Drug: Tegoprazan 50mg QD
* Drug: Lansoprazole 30mg QD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Erosive eshophagitis(LA calssfication Grades A to D) with in 30 days prior to Randomization Those who have experienced heartburn symptoms within 7 days prior to Visit 1(screening date) Exclusion Criteria: Unalbe to undergo upper GI endoscopy H. pylori positive Those who cannot write a clinical trial subject diary Presence of esophageal stricture, ulcerated stricture, gastroesophageal varix, long segment Barrett's esophagus with >3cm length(LSBE), eosinophilic oesophagitis, active digestive ulcer or gastric bleeding on an upper GI endoscopy

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 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 QD<br>Tegoprazan 50mg tablet, once daily, oral administration | Drug: Tegoprazan 50mg QD<br>* Tegoprazan 50mg tablets will be orally administered, once daily, for up to 2 weeks or 4 weeks.<br>|
| Active Comparator: Lansoprazole 30mg QD<br>Lansoprazole 30mg capsule, once dauly, oral administration | Drug: Lansoprazole 30mg QD<br>* Lansoprazole 30mg tablets will be orally administered, once daily, for up to 2 weeks or 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4 weeks cumulative ERD healing rate(%) | Healing is defined as not present erosions or fissures according to the LA classification. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2 weeks ERD healing rate(%) | Healing is defined as not present erosions or fissures according to the LA classification. | 2 weeks | 
| Healing rate(%) at 2 weeks and 4 weeks according to CYP2C19 genotype type | Extensive Metaboliser (EM), Intermediate Metaboliser (IM), Poor Metaboliser (PM) | 2 weeks or 4 weeks | 
| Percentage of days without heartburn through the clinical trial subject dairy (%) | On days with no symptoms of heartburn, '0. It is defined as a case assessed as having no symptoms. | 2 weeks or 4 weeks | 
| RDQ (Reflux Disease Questionnaire) evaluation(mean change in severity) | Average scale change in RDQ severity and frequency at 2 weeks and 4 weeks after administration compared to before administration of investigational drugs for each category (heartburn, indigestion, acid reflux) | 2 weeks or 4 weeks | 
| Incidence of Adverse Events [Safety] | Physical examination(weight-kg)(height-cm), vital signs(SBP, DBP, heart rate, body temperature), adverse reactions, blood chemistry test | 2 weeks or 4 weeks |