Trial Condition(s):

Pain

Safety Trial of Naproxen Sodium/ Diphenhydramine (MUST)

Bayer Identifier:

15560

ClinicalTrials.gov Identifier:

NCT01365052

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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)

Trial Summary

Enrollment Goal
326
Trial Dates
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Phase
3
Could I receive a placebo?
Yes
Products
Aleve PM (BAY98-7111)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Rancho Cucamonga Clinical Trials, Inc.

Rancho Cucamonga, United States, 91730

Status
Completed
 
Locations

FPA Clinical Research

Kissimmee, United States, 34741

Status
Completed
 
Locations

East Valley Family Physicians, PLC

Chandler, United States, 85224

Status
Completed
 
Locations

Mesa Family Medical Center

Mesa, United States, 85203

Status
Completed
 
Locations

Omega Medical Research

Warwick, United States, 02886

Status
Completed
 
Locations

Centennial Medical Group

Elkridge, United States, 21075

Status
Completed
 
Locations

Benchmark Research

San Angelo, United States, 76904

Status
Terminated
 
Locations

Benchmark Research

Metairie, United States, 70006

Status
Completed
 
Locations

Miami Research Associates

South Miami, United States, 33143

Status
Completed
 
Locations

Integra Clinical Research, LLC

San Antonio, United States, 78231

Status
Completed
 
Locations

Benchmark Research

Sacramento, United States, 95816

Status
Completed
 
Locations

Clinical Research Atlanta

Stockbridge, United States, 30281

Status
Completed
 
Locations

Benchmark Research

Fort Worth, United States, 76135

Status
Completed
 
Locations

Colorado Springs Health Partners, PC

Colorado Springs, United States, 80922

Status
Completed
 
Locations

Coastal Carolina Research Center

Mt. Pleasant, United States, 29464

Status
Completed
 
Locations

Premier Research Group

Peoria, United States, 85381

Status
Completed
 
Locations

Lifetree Clinical Research

Salt Lake City, United States, 84106

Status
Completed
 
Locations

Advanced Clinical Research Institute

Anaheim, United States, 92801

Status
Completed
 
Locations

Pines Clinical Research

Pembroke Pines, United States, 33028

Status
Completed
 

Trial Design