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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Peptic Ulcer

Treatments: Drug: DWP14012 20mg placebo; Drug: Lansoprazole 15 mg placebo; Drug: DWP14012 20mg; Drug: Lansoprazole 15 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04784910

DW_DWP14012304

Details and patient eligibility

About

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.

Enrollment: 423 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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423 participants in 2 patient groups

DWP14012 20mg

Experimental group

Description:

orally, once daily

Treatment:

Drug: DWP14012 20mg

Drug: Lansoprazole 15 mg placebo

Lansoprazole 15mg

Active Comparator group

Description:

orally, once daily

Treatment:

Drug: Lansoprazole 15 mg

Drug: DWP14012 20mg placebo