The purpose of this trial is to see how safe the combination of naproxen sodium 440 mg and
diphenhydramine hydrochloride (DPH) 50 mg (the investigational product) is compared to
placebo (capsules containing no drug) when taken for 10 days.
Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine
Completed
Bayer
Phase 4
2008-01-01
The objectives of the study are to evaluate the analgesic and hypnotic efficacy of naproxen
sodium and diphenhydramine combination when compared to naproxen sodium, diphenhydramine, and
an ibuprofen and diphenhydramine combination
Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain
Completed
Bayer
Phase 3
2010-10-01
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.
The purpose of this trial is to see how safe the combination of naproxen sodium 440 mg and
diphenhydramine hydrochloride (DPH) 50 mg (the investigational product) is compared to
placebo (capsules containing no drug) when taken for 10 days.
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