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

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

Outcome

Missed primary endpoint

paper In the second study, the NS 440 mg/DPH 25 mg combination failed to show any significant improvements vs. either component alone. PMID 25996289 ↗

registry analysis (superiority or other test); Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) vs Naproxen Sodium 440 mg (BAYH6689); p = 0.3047; ANCOVA NCT01495858 ↗

registry analysis (superiority or other test); Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) vs DPH 50 mg; p = 0.1677; Log Rank NCT01495858 ↗

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	Small molecule	25 mg	Oral
Subject	Diphenhydramine	Small molecule	50 mg	Oral
Subject	Naproxen	Small molecule	440 mg	Oral

Indications

No indication recorded.