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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

423 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-21

Study Completion Date

2023-12-11

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.

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Detailed Description

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Conditions

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Peptic Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DWP14012 20mg

orally, once daily

Group Type EXPERIMENTAL

DWP14012 20mg

Intervention Type DRUG

DWP14012 20mg, tablet, orally, once daily for up to 24 weeks

Lansoprazole 15 mg placebo

Intervention Type DRUG

Lansoprazole 15mg placebo matching capsule, orally, once daily for up to 24 weeks

Lansoprazole 15mg

orally, once daily

Group Type ACTIVE_COMPARATOR

Lansoprazole 15 mg

Intervention Type DRUG

Lansoprazole 15mg capsule, orally, once daily for up to 24 weeks

DWP14012 20mg placebo

Intervention Type DRUG

DWP14012 20mg placebo-matching tablet, orally, once daily for up to 24 weeks

Interventions

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DWP14012 20mg

DWP14012 20mg, tablet, orally, once daily for up to 24 weeks

Intervention Type DRUG

Lansoprazole 15 mg

Lansoprazole 15mg capsule, orally, once daily for up to 24 weeks

Intervention Type DRUG

DWP14012 20mg placebo

DWP14012 20mg placebo-matching tablet, orally, once daily for up to 24 weeks

Intervention Type DRUG

Lansoprazole 15 mg placebo

Lansoprazole 15mg placebo matching capsule, orally, once daily for up to 24 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male and female adults aged ≥ 19 years at the time of informed consent
2. Subjects who are diagnosed with musculoskeletal disease at screening and require continued treatment with NSAIDs for at least 24 weeks
3. Subjects with at least one of the following risk factors for ulcer development at screening.
4. 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

1. Subjects with esophagitis, gastroesophageal varix, esophagus, Barrett's esophagus, acute gastrointestinal bleeding and else based on the screening EGD results.
2. Subjects who have undergone gastroduodenal surgery or total small bowel resection
3. Subjects with history of clinically significant disease of hepatic, renal, nervous, pulmonary, endocrine, hemato-oncologic, cardiovascular or urinary system
4. Subjects who have had a malignant tumor in the last 5 years
5. Subjects who history of hypersensitivity to the IP ingredients, aspirin and NSAIDs

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No