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

Phase 3

Completed

• Conditions: Peptic Ulcer
• Interventions: Drug: DWP14012 20mg; Drug: Lansoprazole 15 mg; Drug: DWP14012 20mg placebo; Drug: Lansoprazole 15 mg placebo

• Registration Number: NCT04784910
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-04
• Study First Posted: 2021-03-05
• Study Start: 2021-05-21
• Primary Completion: 2023-11-27
• Study Completion: 2023-12-11
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 423

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWP14012 20mg	DWP14012 20mg	orally, once daily
Lansoprazole 15mg	DWP14012 20mg placebo	orally, once daily
Lansoprazole 15mg	Lansoprazole 15 mg	orally, once daily
DWP14012 20mg	Lansoprazole 15 mg placebo	orally, once daily

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of