Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain.

NCT00720057 ↗

Phase 3 Completed 312 enrolled Bayer

RandomizedParallel-groupDouble-blindTreatment

Summary

To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium extended-release tablet, compared to placebo in postsurgical dental pain.

Timeline

Start: 2008-06
Primary completion: 2008-08
Completion: 2008-08

Outcome

Met primary endpoint

paper Primary efficacy analyses: pain intensity was significantly lower over 24 h with ER naproxen sodium vs. placebo (p < 0.001), PMID 26588111 ↗

registry analysis (superiority or other test); Naproxen Sodium ER (BAYH6689) vs Placebo; p <0.001; ANCOVA NCT00720057 ↗

Publications

Laurora I, An R. Efficacy of single-dose, extended-release naproxen sodium 660 mg in postsurgical dental pain: two double-blind, randomized, placebo-controlled trials. Curr Med Res Opin. 2016;32(2):331-42. doi: 10.1185/03007995.2015.1123680. Epub 2015 Dec 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Naproxen	Small molecule	660 mg	Oral