Evaluate Analgesic / Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain

Phase 3 Completed 267 enrolled Bayer

RandomizedParallel-groupTriple-blindTreatment

Summary

The objective of the study is to evaluate the efficacy and safety of a single oral dose of naproxen sodium 440 mg in combination with DPH (diphenhydramine) 25 mg in subjects with postsurgical dental pain and phase advanced sleep.

Timeline

Start: 2011-12
Primary completion: 2012-02
Completion: 2012-02

Publications

Cooper S, Laurora I, Wang Y, Venkataraman P, An R, Roth T. Efficacy and tolerability studies evaluating a sleep aid and analgesic combination of naproxen sodium and diphenhydramine in the dental impaction pain model in subjects with induced transient insomnia. Int J Clin Pract. 2015 Oct;69(10):1149-58. doi: 10.1111/ijcp.12669. Epub 2015 May 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Diphenhydramine	Unknown	25 mg	Oral
Subject	Diphenhydramine	Unknown	50 mg	Oral
Subject	Naproxen	Small molecule	440 mg	Oral

Indications

No indication recorded.