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

Study Overview
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Brief Summary
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This study is designed to confirm the non-inferiority of Tegoprazan 25mg, compared to Lansoprazole 15mg as maintenance therapy in patients with healed erosive esophagitis confirmed by endoscopy following oral administration once daily(QD) for 6 months.

Detailed Description
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This is a double blind, randomized, active-controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 25mg, lansoprazole 15mg).

Official Title
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A Phase 3, Double-blind, Randomized, Active-controlled Study to Evaluate the Safety and Efficacy of Tegoprazan as Maintenance Therapy in Patients With Healed Erosive Esophagitis

Conditions
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Healed Erosive Esophagitis

Intervention / Treatment
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* Drug: Tegoprazan 25mg QD
* Drug: Lansoprazole 15mg QD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Erosive eshophagitis(LA classification Grades A to D) within 12 weeks prior to Randomization Healed erosive esophagitis within 7 days prior to Randomization No heartburn and regurgitation within 7 days prior to Randomization Exclusion Criteria: Unable to undergo upper GI endoscopy Presence of esophageal stricture, ulcerated stricture, gastroesophageal varix, long segment Barrett's esophagus with >3 cm length(LSBE), active digestive ulcer, gastric bleeding or malignant tumors on an upper GI endoscopy Diagnosed with primary esophageal motility disorder, irritable bowel syndome(IBS) or inflammatory bowel disease(IBD) History of acid-suppressive, esophageal or gastric surgeries

Ages Eligible for Study
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Minimum Age: 20 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 25mg QD<br>Tegoprazan 25mg tablet, once daily, oral administration | Drug: Tegoprazan 25mg QD<br>* Tegoprazan 25mg tablets will be orally administered, once daily, for up to 6 months.<br>|
| Active Comparator: Lansoprazole 15mg QD<br>Lansoprazole 15mg capsule, once daily, oral administration | Drug: Lansoprazole 15mg QD<br>* Lansoprazole 15mg capsules will be orally administered, once daily, for up to 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic remission rate of EE at 24-week | Endoscopic remission: No endoscopic recurrence of erosion(LA grade A to D) during maintenance period(24 weeks) | 24-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic remission rate of EE at 12-week | Endoscopic remission: No endoscopic recurrence of erosion(LA grades A to D) during maintenance period(12 weeks) | 12-week |