A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain
Summary
To compare the duration of analgesic efficacy as determined by the time to rescue medication of a single oral dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo over 24 hours in subjects experiencing moderate to severe post-impaction surgery dental pain. To compare the overall analgesic effect (SPID 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo. To compare the overall relief from pain (TOTPAR 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.
Timeline
- Start
- 2018-02-12
- Primary completion
- 2018-07-06
- Completion
- 2018-07-10
Outcome
Met primary endpoint
registry analysis (superiority test); Naproxen Sodium (Aleve, BAY117031) vs Ibuprofen (Advil); p <0.001; Log Rank NCT03404206 ↗
paper the time to rescue medication was significantly (p < .001) longer with NAPSO than IBU and placebo. PMID 31402718 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ibuprofen | Small molecule | 400 mg | Oral |
| Subject | Naproxen | Small molecule | 440 mg | Oral |