Clinical trial NCT01365052: Safety Trial of Naproxen Sodium/ Diphenhydramine
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Maximum Use Safety Trial
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-06-03
Enrollment: 326
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.


Eligibility 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)

Primary outcomes:
measure: Percentage of Subjects With Any Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product
timeFrame: 10 days after randomization
measure: Percentage of Subjects With Any Serious Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product
timeFrame: 10 days after randomization
Secondary outcomes:
Other outcomes:
measure: Percentage of Subjects Who Discontinued Due to an Adverse Event for Those Subjects Who Are Randomized and Take at Least One Dose of Investigational Product
timeFrame: 10 days after randomization
measure: Treatment Compliance - Number of Capsules Taken
timeFrame: 10 days after randomization
measure: Treatment Compliance - Duration of Exposure to Treatment in Days
timeFrame: 10 days after randomization
Locations:
city: Chandler
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: Peoria
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Rancho Cucamonga
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Kissimmee
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Stockbridge
country: United States
state: Georgia
city: Metairie
country: United States
state: Louisiana
city: Elkridge
country: United States
state: Maryland
city: Warwick
country: United States
state: Rhode Island
city: Mt. Pleasant
country: United States
state: South Carolina
city: Fort Worth
country: United States
state: Texas
city: San Angelo
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: