Safety Trial of Naproxen Sodium/ Diphenhydramine

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Safety and Tolerability Trial of Naproxen Sodium/ Diphenhydramine Combination in an OTC Population

Conditions
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Pain

Intervention / Treatment
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* Drug: Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111)<br> | Drug: Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111)<br>* 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<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maximum Use Safety Trial