check_circleStudy Completed

Pain

Bayer Identifier:

15560

ClinicalTrials.gov Identifier:

NCT01365052

EudraCT Number:

Not Available

EU CT Number:

Not Available
Safety Trial of Naproxen Sodium/ Diphenhydramine

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.

Key Participants Requirements

Sex

Both

Age

12 - N/A
  • - 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).


  • - 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
May 2011 - July 2011
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Aleve PM (BAY98-7111)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Rancho Cucamonga Clinical Trials, Inc.Rancho Cucamonga, 91730, United States
Completed
FPA Clinical ResearchKissimmee, 34741, United States
Completed
East Valley Family Physicians, PLCChandler, 85224, United States
Completed
Mesa Family Medical CenterMesa, 85203, United States
Completed
Omega Medical ResearchWarwick, 02886, United States
Completed
Centennial Medical GroupElkridge, 21075, United States
Terminated
Benchmark ResearchSan Angelo, 76904, United States
Completed
Benchmark ResearchMetairie, 70006, United States
Completed
Miami Research AssociatesSouth Miami, 33143, United States
Completed
Integra Clinical Research, LLCSan Antonio, 78231, United States
Completed
Benchmark ResearchSacramento, 95816, United States
Completed
Clinical Research AtlantaStockbridge, 30281, United States
Completed
Benchmark ResearchFort Worth, 76135, United States
Completed
Colorado Springs Health Partners, PCColorado Springs, 80922, United States
Completed
Coastal Carolina Research CenterMt. Pleasant, 29464, United States
Completed
Premier Research GroupPeoria, 85381, United States
Completed
Lifetree Clinical ResearchSalt Lake City, 84106, United States
Completed
Advanced Clinical Research InstituteAnaheim, 92801, United States
Completed
Pines Clinical ResearchPembroke Pines, 33028, United States

Primary Outcome

  • Percentage of subjects with any adverse event for those subjects who were randomized and took at least one dose of investigational product
    date_rangeTime Frame:
    10 days after randomization
    enhanced_encryption
    Safety Issue:
    Yes
  • Percentage of subjects with any serious adverse event for those subjects who were randomized and took at least one dose of investigational product
    date_rangeTime Frame:
    10 days after randomization
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Safety and Tolerability Trial of Naproxen Sodium/ Diphenhydramine Combination in an OTC Population
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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