Safety Trial of Naproxen Sodium/ Diphenhydramine

Condition(s) targeted: Pain

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

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Primary outcome:

Percentage of Subjects With Any Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product

Percentage of Subjects With Any Serious Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

Chandler, Arizona 85224, United States

Mesa, Arizona 85203, United States

Peoria, Arizona 85381, United States

Anaheim, California 92801, United States

Rancho Cucamonga, California 91730, United States

Sacramento, California 95816, United States

Colorado Springs, Colorado 80922, United States

Kissimmee, Florida 34741, United States

Pembroke Pines, Florida 33028, United States

South Miami, Florida 33143, United States

Stockbridge, Georgia 30281, United States

Metairie, Louisiana 70006, United States

Elkridge, Maryland 21075, United States

Warwick, Rhode Island 02886, United States

Mt. Pleasant, South Carolina 29464, United States

Fort Worth, Texas 76135, United States

San Angelo, Texas 76904, United States

San Antonio, Texas 78231, United States

Salt Lake City, Utah 84106, United States

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Starting date: May 2011
Last updated: May 13, 2015