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

Phase 3 Completed 712 enrolled Bayer

RandomizedParallel-groupTriple-blindTreatment

Summary

The objective of the study is to evaluate the efficacy and safety of a single oral dose of two dose combinations of naproxen sodium and diphenhydramine (DPH) to demonstrate that naproxen sodium/DPH combination provides added clinical benefit to sleep improvement than either single ingredient alone in subjects with post-surgical dental pain and phase advanced sleep.

Timeline

Start: 2010-10
Primary completion: 2011-01
Completion: 2011-02

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
Comparator	Diphenhydramine	Unknown	50 mg	Oral
Comparator	Naproxen	Small molecule	220 mg	Oral
Comparator	Naproxen	Small molecule	440 mg	Oral

Indications

No indication recorded.