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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03566979 | Efficacy and Safety Study of a Test Naproxen Sodium 220mg Tablet in Postoperative Dental Pain | PHASE3 | COMPLETED | 501 | — | — | Aug 13, 2018 | Apr 15, 2019 | Apr 9, 2020 | 1 | United States |
Minutes until confirmed first perceptible pain relief was 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 first perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief.
| Arm | Type | Description |
|---|---|---|
| Test naproxen sodium tablet | EXPERIMENTAL | Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX) |
| Commercial naproxen sodium tablet | ACTIVE_COMPARATOR | Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets |
| Commercial naproxen sodium liquid gels capsule | ACTIVE_COMPARATOR | Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules |
| Placebo tablet | PLACEBO_COMPARATOR | Single dose of two Placebo tablets |
| Name | Type | Description |
|---|---|---|
| Test naproxen sodium tablet | DRUG | Single dose of 2 test naproxen sodium 220 mg tablets |
| Commercial naproxen sodium tablet | DRUG | Single dose of 2 naproxen sodium 220 mg tablets |
| Commercial naproxen sodium liquid gels capsule | DRUG | Single dose of 2 naproxen sodium 220 mg liquid gel capsules |
| Placebo tablet | DRUG | 2 placebo tablets |
Inclusion Criteria: 1. 17 - 50 years old 2. Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (inclusive) at screening 3. Dental extraction of three or four third molars 4. Meets post-surgical pain 5. Females of childbearing potential and males agree to contraceptive requ...