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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04784910

Enrollment

423

Registered

2021-03-05

Start date

2021-05-21

Completion date

2023-12-11

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peptic Ulcer

Brief summary

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.

Interventions

DRUGDWP14012 20mg

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

DRUGLansoprazole 15 mg

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

DRUGDWP14012 20mg placebo

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

DRUGLansoprazole 15 mg placebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Proportion of subjects who develop peptic ulcer by Week 24 as assessed by investigator	at 24 weeks

Secondary

Measure	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026