Evaluate Efficacy and Safety of Extended Release (ER) Naproxen Sodium

Phase 3 Completed 300 enrolled Bayer

RandomizedParallel-groupTriple-blindTreatment

Summary

The objective is to evaluate pain relief of the extended release naproxen sodium 660 mg tablet compared to commercial naproxen sodium 220 mg tablet over 24 hours in patients with postsurgical dental pain.

Timeline

Start: 2011-06
Primary completion: 2011-09
Completion: 2011-09

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	220 mg	Oral
Subject	Naproxen	Small molecule	660 mg	Oral

Indications

No indication recorded.