Study to Evaluate the Safety, Efficacy of Tegoprazan for the Prevention of PUD in Patients on Treatment With NSAIDs
- Conditions
- Preventive Peptic Ulcer
- Interventions
- Registration Number
- NCT04840550
- Lead Sponsor
- HK inno.N Corporation
- 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 administration of tegoprazan 25 mg QD or lansoprazole 15 mg QD in patients on long-term treatment with NSAIDs.
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 390
- ≥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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lansoprazole 15mg Lansoprazole 15 mg Lansoprazole 15mg capsules will be orally administered, once a day, with NSAIDs, for up to 6 months. Tegoprazan 25mg Tegoprazan 25 mg Tegoprazan 25mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.
- Primary Outcome Measures
Name Time Method Proportion of subjects with gastric and/or duodenal ulcers at Week 24 week 24 The proportion of subjects with gastric and/or duodenal ulcers on upper GI endoscopy at Week 24
- Secondary Outcome Measures
Name Time Method Proportion of subjects without NSAID-related GI symptoms at Weeks 4, 12, and 24 week 4, 12, 24 GI symptoms are as follows; Heartburn, Regurgitation, Upper abdominal pain or discomfort
Trial Locations
- Locations (2)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
The catholic univ. of Korea Eunpyeong ST. Mari's hospital
🇰🇷Seoul, Korea, Republic of