Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
acetaminophen Caplet · 1 trial · 1 indication
Minutes until confirmed first perceptible pain relief are achieved. Stopwatch is started after the subject takes the study medication. The subject is instructed to stop the stopwatch when they first begin to feel any pain relief. The first perceptible pain relief is confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief.
| Arm | Type | Description |
|---|---|---|
| Test acetaminophen | EXPERIMENTAL | acetaminophen tablet and placebo caplet and placebo liquid-filled capsule |
| Commercial acetaminophen | ACTIVE_COMPARATOR | acetaminophen caplet and placebo tablet and placebo liquid-filled capsule |
| Commercial ibuprofen | ACTIVE_COMPARATOR | ibuprofen liquid-filled capsule and placebo tablet and placebo caplet |
| Placebo | PLACEBO_COMPARATOR | Placebo tablet and placebo caplet and placebo liquid-filled capsule |
| Name | Type | Description |
|---|---|---|
| acetaminophen Tablet | DRUG | 2 test acetaminophen 500 mg tablets |
| acetaminophen Caplet | DRUG | 2 commercial acetaminophen 500 mg caplets |
| ibuprofen Liquid-filled capsule | DRUG | 2 commercial ibuprofen 200 mg Liquid-filled capsules |
| Placebo Tablet | DRUG | 2 placebo tablets |
| Placebo Caplet | DRUG | 2 placebo caplets |
| Placebo Liquid-filled capsule | DRUG | 2 placebo Liquid-filled capsules |
Inclusion Criteria: 1. 17 years to 50 years old 2. Weight 100 lbs or greater with a body mass index (BMI) 18-30 inclusive 3. Dental extraction of three or four molars 4. Experience moderate to severe pain after extraction of third molars 5. Females of childbearing age must be willing to use accepta...