Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine
Condition: Sleep
Intervention: Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg; Naproxen Sodium 440 mg (BAYH6689); Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg; Naproxen Sodium 220 mg (BAYH6689); DPH 50mg; Ibuprofen 400 mg / Diphenhydramine citrate 76 mg
Intervention description: Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.; Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.; One dose of naproxen sodium 220 mg plus diphenhydramine 50 mg; Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.; Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.; Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Intervention MeSH terms: Diphenhydramine; Promethazine; Ibuprofen; Naproxen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 162.0
Sex: All
Minimum age: 16 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Naproxen sodium; Diphenhydramine; Drugs, Investigational

Summary:

      The objectives of the study are to evaluate the analgesic and hypnotic efficacy of naproxen
      sodium and diphenhydramine combination when compared to naproxen sodium, diphenhydramine, and
      an ibuprofen and diphenhydramine combination
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, ambulatory, male and female volunteers between 16-45 years of age;

          -  Scheduled to undergo surgical removal of 1 to 3 impacted third molars, one of which
             must be at least a partial bony mandibular impaction;

          -  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 by 2030 h
             +/- 15 minutes 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
             antiinflammatory drugs (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 negative 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;