Study to Evaluate the Safety, Efficacy of Tegoprazan for the Prevention of PUD in Patients on Treatment With NSAIDs

Study Overview
=================
Brief Summary
-----------------
This study is designed to confirm the non-inferiority of Tegoprazan 25 mg, compared to Lansoprazole 15 mg, to prevent gastroduodenal ulcers and verify the safety of tegoprazan following oral administration of tegoprazan 25 mg QD or lansoprazole 15 mg QD in patients on long-term treatment with NSAIDs.

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

Official Title
-----------------
A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tegoprazan 25 mg for the Prevention of Peptic Ulcer Disease in Patients on Continuous Long-term Treatment With NSAIDs

Conditions
-----------------
Preventive Peptic Ulcer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥60 years of age, or ≥20 years of age with a history of gastroduodenal ulcers (gastric and/or duodenal ulcers) at screening Requires continued treatment with NSAIDs for ≥24 weeks Exclusion Criteria: Has an active stage (A1, A2) or healing stage (H1, H2) of gastroduodenal ulcers per the Sakita-Miwa classification identified by upper GI endoscopy at screening Has uncontrolled severe hypertension Has severe heart failure, congestive heart failure (NYHA Ⅱ to Ⅳ), ischemic heart disease (unstable angina, myocardial infarction), or peripheral artery disease, or has undergone coronary artery bypass graft (CABG) who is considered ineligible for treatment with NSAIDs Has a positive H. pylori test at screening

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tegoprazan 25mg<br>Tegoprazan 25mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months. | Drug: Tegoprazan 25 mg<br>* Tegoprazan 25 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.<br>|
| Active Comparator: Lansoprazole 15mg<br>Lansoprazole 15mg capsules will be orally administered, once a day, with NSAIDs, for up to 6 months. | Drug: Lansoprazole 15 mg<br>* Lansoprazole 15 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with gastric and/or duodenal ulcers at Week 24 | The proportion of subjects with gastric and/or duodenal ulcers on upper GI endoscopy at Week 24 | week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects without NSAID-related GI symptoms at Weeks 4, 12, and 24 | GI symptoms are as follows; Heartburn, Regurgitation, Upper abdominal pain or discomfort | week 4, 12, 24 |