Safety Trial of Naproxen Sodium/ Diphenhydramine

Recruitment & Eligibility

Inclusion Criteria

Healthy, ambulatory, male and female volunteers ages 12 and older
History of experiencing occasional sleeplessness accompanied by aches and pains at least two times, but not continually for more than 14 days per month, in at least 2 of the past 3 months
Female subjects of childbearing potential must be using a medically acceptable form of birth control, e.g., oral or patch contraceptives, intrauterine device, Depo-Provera®, for at least 1 month prior to screening (3 months on oral contraceptives), or double-barrier and have a negative pregnancy test at Screening. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or have had a hysterectomy and/or bilateral oophorectomy
Be willing and able to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol
Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial, (subjects <18 years of age must sign a written assent and have parental or guardian consent).

Exclusion Criteria

History of hypersensitivity to naproxen sodium, acetaminophen, or any NSAIDs (Nonsteroidal Antiinflammatory Drugs), diphenhydramine or any other antihistamines, and similar pharmacological agents or components of the product
Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies with the last 5 years
A history of a chronic or severe sleep problem which does not respond to OTC (Over-the-counter) medication and/or requires a prescription hypnotic or sedative
Currently experiencing chronic pain or on chronic NSAID therapy (defined as taking a daily [5 to 7 days per week] regimen of prescription or OTC NSAIDs)
Current or past history of gastrointestinal ulcers or bleeding or other bleeding disorders
Use of any OTC or prescription medications with which the administration of naproxen, acetaminophen, or any NSAIDs, diphenhydramine or any other antihistamines or sedatives, is contraindicated
Chronic use of other products containing diphenhydramine, including topical products
Use of steroids or blood thinning (anticoagulant) drugs (aspirin 81 mg is permitted if the dose has been taken for at least one month prior to screening)

Study & Design

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111)	Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111)	-

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Any Serious Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product	10 days after randomization	Please see further details in AE section
Percentage of Subjects With Any Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product	10 days after randomization	Please see further details in Adverse Events (AE) section

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility