Safety Trial of Naproxen Sodium/ Diphenhydramine (MUST)

Bayer

Status and phase

Completed

Phase 3

Conditions

Pain

Treatments

Drug: Placebo

Drug: Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01365052

15560

Details and patient eligibility

About

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.

Enrollment

326 patients

Sex

All

Ages

12+ years old

Volunteers

Accepts Healthy Volunteers

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)