Conditions: Pain
Keywords: Maximum Use Safety Trial
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 326
Healthy volunteers: yes

Brief summary:
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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111) intervention 2: Placebo
Intervention descriptions: intervention 1: 2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days intervention 2: 2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days

Protocol document: