Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111); Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111); Naproxen sodium 440 mg (BAYH6689); DPH 50 mg
Intervention description: Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose; Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose; Participants received two Naproxen sodium 220 mg tablets orally, single dose; Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Intervention MeSH terms: Naproxen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 712.0
Sex: All
Minimum age: 12 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Naproxen sodium; Diphenhydramine

Summary:

      The objective of the study is to evaluate the efficacy and safety of a single oral dose of
      two dose combinations of naproxen sodium and diphenhydramine (DPH) to demonstrate that
      naproxen sodium/DPH combination provides added clinical benefit to sleep improvement than
      either single ingredient alone in subjects with post-surgical dental pain and phase advanced
      sleep.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, ambulatory, male and female volunteers ages 12 and older

          -  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 nonchildbearing potential must be amenorrheic for
             at least 2 years or had a hysterectomy and/or bilateral oophorectomy

          -  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, diphenhydramine, nonsteroidal
             anti-inflammatory drug (NSAIDS), tramadol, aspirin or any other antihistamine and
             similar pharmacological agents or components of the products

          -  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