Conditions: Sleep
Keywords: Naproxen sodium Diphenhydramine Drugs, Investigational
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 162
Healthy volunteers: no

Brief summary:
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

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None

Interventions: intervention 1: Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg intervention 2: Naproxen Sodium 440 mg (BAYH6689) intervention 3: Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg intervention 4: Naproxen Sodium 220 mg (BAYH6689) intervention 5: DPH 50mg intervention 6: Ibuprofen 400 mg / Diphenhydramine citrate 76 mg
Intervention descriptions: intervention 1: Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally. intervention 2: Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. intervention 3: One dose of naproxen sodium 220 mg plus diphenhydramine 50 mg intervention 4: Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally. intervention 5: Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally. intervention 6: Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.

Protocol document: