Study to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer

Study Overview
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Brief Summary
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The study aims to demonstrate the preventive effect of DWP14012 20 mg for peptic ulcer is non-inferior to that of Lansoprazole 15 mg in terms of prevention of peptic ulcer and confirm the safety of DWP14012 20 mg.

Official Title
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A Multi-center, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer

Conditions
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Peptic Ulcer

Intervention / Treatment
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* Drug: DWP14012 20mg
* Drug: Lansoprazole 15 mg
* Drug: DWP14012 20mg placebo
* Drug: Lansoprazole 15 mg placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female adults aged ≥ 19 years at the time of informed consent Subjects who are diagnosed with musculoskeletal disease at screening and require continued treatment with NSAIDs for at least 24 weeks Subjects with at least one of the following risk factors for ulcer development at screening. Subjects who have no gastric or duodenal mucosal break or have ulcer in the scarring stage based on the EGD result at screening. Exclusion Criteria: Subjects with esophagitis, gastroesophageal varix, esophagus, Barrett's esophagus, acute gastrointestinal bleeding and else based on the screening EGD results. Subjects who have undergone gastroduodenal surgery or total small bowel resection Subjects with history of clinically significant disease of hepatic, renal, nervous, pulmonary, endocrine, hemato-oncologic, cardiovascular or urinary system Subjects who have had a malignant tumor in the last 5 years Subjects who history of hypersensitivity to the IP ingredients, aspirin and NSAIDs

Ages Eligible for Study
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Minimum Age: 19 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWP14012 20mg<br>orally, once daily | Drug: DWP14012 20mg<br>* DWP14012 20mg, tablet, orally, once daily for up to 24 weeks<br>Drug: Lansoprazole 15 mg placebo<br>* Lansoprazole 15mg placebo matching capsule, orally, once daily for up to 24 weeks<br>|
| Active Comparator: Lansoprazole 15mg<br>orally, once daily | Drug: Lansoprazole 15 mg<br>* Lansoprazole 15mg capsule, orally, once daily for up to 24 weeks<br>Drug: DWP14012 20mg placebo<br>* DWP14012 20mg placebo-matching tablet, orally, once daily for up to 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who develop peptic ulcer by Week 24 as assessed by investigator |  | at 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who develop peptic ulcer by Week 12 as assessed by investigator |  | at 12 weeks | 
| Proportion of subjects with endoscopic gastric or duodenal bleeding** by Week 12 and Week 24 |  | at 12, 24 weeks |