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Also known as Commercial naproxen sodium tablet
Commercial naproxen · 1 trial · 1 indication
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...
Commercial naproxen is a small molecule pain medication developed by Johnson & Johnson (ticker JNJ). It is being studied in a Phase 3 clinical program for post-operative dental pain. The drug is also known as commercial naproxen sodium tablet.
Commercial naproxen is being evaluated for the treatment of post-operative dental pain. It has completed a Phase 3 clinical trial in this indication, which enrolled 501 participants. The drug is not yet approved for this use and remains investigational.
Commercial naproxen is developed by Johnson & Johnson, which trades under the ticker symbol JNJ. The company is responsible for the clinical development of the drug, including the completed Phase 3 trial in post-operative dental pain.
Commercial naproxen is in Phase 3 development. One Phase 3 trial has been completed, and there are currently no active trials. The drug is investigational and has not been approved by the FDA for any indication.
Commercial naproxen has been studied in one completed Phase 3 trial, NCT03566979, titled "Efficacy and Safety Study of a Test Naproxen Sodium 220mg Tablet in Postoperative Dental Pain." The trial enrolled 501 participants in the United States and was randomized, double-blind, and placebo-controlled.
Yes, commercial naproxen is also known as commercial naproxen sodium tablet. Both names refer to the same investigational product developed by Johnson & Johnson for post-operative dental pain.