Preventive Peptic Ulcer
Conditions
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).
Interventions
Lansoprazole 15 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.
DRUGTegoprazan 25 mg
Tegoprazan 25 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Contacts
Primary ContactYugyeong Park
Backup ContactJiwon Lee
Outcome results
None listed