Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03224403 | Randomized, Double-Blind, Single-Dose, Efficacy and Safety Study of Test Acetaminophen Tablet in Postoperative Dental Pain | PHASE3 | COMPLETED | 664 | — | — | Jul 19, 2017 | Apr 12, 2018 | Apr 15, 2021 | 1 | United States |
Minutes until confirmed perceptible pain relief is achieved. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief.
| Arm | Type | Description |
|---|---|---|
| Test acetaminophen | EXPERIMENTAL | Test acetaminophen 1000 mg dose |
| Commercial acetaminophen | ACTIVE_COMPARATOR | Commercial acetaminophen 1000 mg dose |
| Commercial ibuprofen | ACTIVE_COMPARATOR | Commercial ibuprofen, 400 mg dose |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Test acetaminophen | DRUG | single dose of 2 Test acetaminophen 500 mg tablets |
| Commercial acetaminophen | DRUG | single dose of 2 acetaminophen 500 mg caplets |
| Commercial ibuprofen | DRUG | Single dose of 2 ibuprofen 200 mg Liquid-filled Capsules |
| Placebo | DRUG | 2 placebo caplets |
Inclusion Criteria: 1. 17 to 50 years old 2. Weigh 100 lbs. or greater and have a body mass index (BMI) of 18 to 30 (inclusive) 3. Dental extraction of three or four third molars 4. Meets post-surgical pain criteria 5. Females of childbearing age must be willing to use acceptable method of birth co...