Evaluate Analgesic / Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain
NCT ID: NCT01495858
Last Updated: 2015-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
267 participants
INTERVENTIONAL
2011-12-31
2012-02-29
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
TREATMENT
TRIPLE
Study Groups
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Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Naproxen Sodium 440 mg (BAYH6689)
Naproxen Sodium 440 mg (BAYH6689)
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
DPH 50 mg
DPH 50 mg
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Interventions
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Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Naproxen Sodium 440 mg (BAYH6689)
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
DPH 50 mg
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Eligibility Criteria
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Inclusion Criteria
* Scheduled to undergo surgical removal of a minimum of two third molars of which at least one has to be a mandibular third molar. The mandibular extraction(s) required by each subject must meet one of the following scenarios:
* one full bony impaction
* two partial bony impactions
* one full bony impaction and one partial bony impaction
* one full bony impaction and one soft tissue impaction
* one full bony impaction and one erupted third molar. Two full bony mandibular impactions are not allowed. Maxillary third molars may be removed regardless of impaction level.
* Have moderate to severe postoperative pain on the Categorical Pain Rating Scale and a score of \>/= 50 mm on the 100-mm visual analog Pain Severity Rating Scale between 1600 hour and 1830 hour on the day of surgery
* Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and prior to surgery. Female subjects of non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy.
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 within the last 5 years
* Relevant concomitant disease such as asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than 50 percent obstruction (polyposis nasi, marked septal deviation) that can interfere with the conduct of the study in the judgment of the investigator
* Current or past history of bleeding disorder(s)
* Acute illness or local infection prior to surgery that can interfere with the conduct of the study in the judgment of the investigator
* Chronic use of antihistamines defined as using 5 or more times a week for 2 or more consecutive weeks during the past 3 months
* Positive alcohol breathalyzer test and positive urine drug test prior to surgery
* Females who are pregnant or lactating
* Chronic or severe sleep problems that do not respond to Over the Counter (OTC) medication and requires a prescription hypnotic or sedative
* Habitually spends less than 6.5 hours in bed
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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Austin, Texas, United States
Salt Lake City, Utah, United States
Countries
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References
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Cooper S, Laurora I, Wang Y, Venkataraman P, An R, Roth T. Efficacy and tolerability studies evaluating a sleep aid and analgesic combination of naproxen sodium and diphenhydramine in the dental impaction pain model in subjects with induced transient insomnia. Int J Clin Pract. 2015 Oct;69(10):1149-58. doi: 10.1111/ijcp.12669. Epub 2015 May 21.
Other Identifiers
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15881
Identifier Type: -
Identifier Source: org_study_id
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