Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Peptic Ulcer
Eligibility:
All Genders
19+ years
Phase:
PHASE3
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 DW...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2023
Estimated Enrollment :
423 Patients enrolled
Trial Details
Trial ID
NCT04784910
Start Date
May 21 2021
End Date
December 11 2023
Last Update
July 8 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Asan Medical Center
Seoul, South Korea