Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
326 participants
INTERVENTIONAL
2011-05-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111)
Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111)
2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
Placebo
Placebo
2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
Interventions
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Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111)
2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
Placebo
2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
12 Years
ALL
Yes
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Chandler, Arizona, United States
Mesa, Arizona, United States
Peoria, Arizona, United States
Anaheim, California, United States
Rancho Cucamonga, California, United States
Sacramento, California, United States
Colorado Springs, Colorado, United States
Kissimmee, Florida, United States
Pembroke Pines, Florida, United States
South Miami, Florida, United States
Stockbridge, Georgia, United States
Metairie, Louisiana, United States
Elkridge, Maryland, United States
Warwick, Rhode Island, United States
Mt. Pleasant, South Carolina, United States
Fort Worth, Texas, United States
San Angelo, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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15560
Identifier Type: -
Identifier Source: org_study_id
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