Conditions: Pain, Postoperative
Keywords: Naproxen sodium Diphenhydramine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 712
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111) intervention 2: Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111) intervention 3: Naproxen sodium 440 mg (BAYH6689) intervention 4: DPH 50 mg
Intervention descriptions: intervention 1: Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose intervention 2: Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose intervention 3: Participants received two Naproxen sodium 220 mg tablets orally, single dose intervention 4: Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose

Protocol document: