Study at a glance
Active-controlled, physician-relevant comparator
Design
Randomized, double-blind, multicenter Phase III
Population
Long-term NSAID users requiring ulcer prevention
Arms
Tegoprazan 25 mg vs lansoprazole 15 mg
Follow-up
Up to 24 weeks
Primary efficacy endpoint
Week 24 peptic ulcer incidence
Non-inferior
Tegoprazan 25 mg met the non-inferiority criterion versus lansoprazole 15 mg for prevention of NSAID-induced gastroduodenal ulcers.
p=0.0004
Primary endpoint met
24
Weeks of ulcer prevention follow-up
Why prevention matters
Chronic NSAID exposure raises gastroduodenal ulcer risk
Long-term NSAID therapy can compromise upper gastrointestinal mucosal protection. For patients who need continuous NSAIDs, proactive acid suppression is a key strategy to reduce peptic ulcer development.
Clinical context
Continuous NSAID users often require durable gastroprotection.
Clinical question
Can tegoprazan provide ulcer prevention comparable to lansoprazole?
Key findings by endpoint
Per-protocol efficacy analysis: 269 patients
| Endpoint | Timing | Finding | Reported statistic |
|---|---|---|---|
| Peptic ulcer incidence | Week 24 | Tegoprazan non-inferior to lansoprazole | p=0.0004 |
| Heartburn-free rate | Week 12 | Favored tegoprazan | Direction reported; rate not specified in provided data |
| Adverse drug reactions | Up to 24 weeks | Comparable between groups | No significant difference reported |
| Serious adverse events | Up to 24 weeks | Comparable between groups | No significant difference reported |
392
Patients randomized 1:1
269
Included in per-protocol analysis
25 mg vs 15 mg
Tegoprazan dose compared with lansoprazole
Clinical takeaway
For patients requiring continuous long-term NSAID therapy, tegoprazan 25 mg appears to be a clinically effective and well-tolerated alternative to lansoprazole 15 mg for peptic ulcer prevention.