Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Lansoprazole and naproxen and aspirin
Lansoprazole · 5 trials · 7 indications
The number of participants that developed gastric ulcer and/or duodenal ulcer at month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.
| Arm | Type | Description |
|---|---|---|
| Lansoprazole 15 mg QD | EXPERIMENTAL | - |
| Gefarnate 50 mg BID | ACTIVE_COMPARATOR | - |
| Lansoprazole 30 mg QD + Naproxen 500 mg BID | EXPERIMENTAL | (and added aspirin) |
| Celecoxib 200 mg QD | ACTIVE_COMPARATOR | (and added aspirin) |
| Lansoprazole IV 30 mg QD | EXPERIMENTAL | - |
| Lansoprazole Capsule 30 mg QD | ACTIVE_COMPARATOR | - |
| Lansoprazole 0.5 mg/kg QD | EXPERIMENTAL | - |
| Lansoprazole 1.0 mg/kg QD | EXPERIMENTAL | - |
| Lansoprazole 2.0 mg/kg QD | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Lansoprazole | DRUG | Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months. |
| Gefarnate | DRUG | Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months. |
| Lansoprazole and naproxen and aspirin | DRUG | Lansoprazole 30 mg, capsules, orally once daily; Naproxen 500 mg, capsules, orally, twice daily; and aspirin 81 mg or 325 mg, tablets, orally, once daily for up to 12 weeks. |
| Celecoxib and aspirin | DRUG | Celecoxib 200 mg, capsules, orally once daily and aspirin 81 mg or 325 mg, tablets, orally, once daily for up to 12 weeks. |
Inclusion Criteria: * The patient was on nonsteroid anti-inflammatory drug (NSAID) treatment on the day when consent was obtained, and requires the long-term continuous treatment even after treatment with the investigational drug is started. * The patient was confirmed to have a history of gastric ...