Status:
UNKNOWN
Study to Evaluate the Safety, Efficacy of Tegoprazan for the Prevention of PUD in Patients on Treatment With NSAIDs
Lead Sponsor:
HK inno.N Corporation
Conditions:
Preventive Peptic Ulcer
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
This study is designed to confirm the non-inferiority of Tegoprazan 25 mg, compared to Lansoprazole 15 mg, to prevent gastroduodenal ulcers and verify the safety of tegoprazan following oral administr...
Detailed Description
This is a double-blind, randomized, active-controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 25 mg, lansoprazole 15 mg).
Eligibility Criteria
Inclusion
- ≥60 years of age, or ≥20 years of age with a history of gastroduodenal ulcers (gastric and/or duodenal ulcers) at screening
- Requires continued treatment with NSAIDs for ≥24 weeks
Exclusion
- Has an active stage (A1, A2) or healing stage (H1, H2) of gastroduodenal ulcers per the Sakita-Miwa classification identified by upper GI endoscopy at screening
- Has uncontrolled severe hypertension
- Has severe heart failure, congestive heart failure (NYHA Ⅱ to Ⅳ), ischemic heart disease (unstable angina, myocardial infarction), or peripheral artery disease, or has undergone coronary artery bypass graft (CABG) who is considered ineligible for treatment with NSAIDs
- Has a positive H. pylori test at screening
Key Trial Info
Start Date :
May 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT04840550
Start Date
May 7 2021
End Date
July 1 2024
Last Update
July 14 2023
Active Locations (2)
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1
Samsung Medical Center
Seoul, South Korea
2
The catholic univ. of Korea Eunpyeong ST. Mari's hospital
Seoul, South Korea