Evaluate Efficacy and Safety of Extended Release (ER) Naproxen Sodium
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Naproxen Sodium ER (BAYH6689); Naproxen Sodium IR (Aleve, BAYH6689); Naproxen Sodium ER Placebo; Naproxen Sodium IR Placebo
Intervention description: 660 mg Naproxen Sodium extended release tablet, orally administered once daily for 24 hours; 220 mg Naproxen Sodium instant release tablet, orally administered 3 times daily (TID) for 24 hours; Matching placebo of 660 mg Naproxen Sodium ER for 24 hours; Matching placebo of 220 mg Naproxen Sodium IR (Aleve) for 24 hours
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: 300.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Naproxen Sodium,; dental pain

Summary:

      The objective is to evaluate pain relief of the extended release naproxen sodium 660 mg
      tablet compared to commercial naproxen sodium 220 mg tablet over 24 hours in patients with
      postsurgical dental pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, ambulatory, male and female volunteers 15 years of age and above

          -  Scheduled to undergo surgical removal of up to two impacted third molars, one of which
             must be mandibular full or partial bony impaction and the other a maxillary impaction

          -  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, NuvaRing,
             Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and
             prior to surgery

          -  Have not taken any form of medication or herbal supplements (ie, St. Johns Wort)
             within 5 days of admission (except for oral contraceptives, prophylactic antibiotics,
             or other routine medications to treat benign conditions, such as antibiotics to treat
             acne) and agree not to take any medication (other than that provided to them)
             throughout the study

          -  Have not consumed alcoholic beverages, or foods and beverages containing xanthines
             (examples, coffee, tea, chocolate, and colas) after midnight prior to surgery and
             agree not to consume any of these foods or beverages throughout the evaluation period

          -  Use of only short-acting local anesthetic (e.g., mepivacaine or lidocaine)
             preoperatively, with or without vasoconstrictor and nitrous oxide

          -  Have moderate to severe postoperative pain on the Categorical Pain Intensity Scale (a
             score of at least 2 on a 4 point scale) and a score of ≥ 50 mm on the 100 mm Visual
             Analog Scale (VAS) within 4 hours postsurgery, but no later than 1330 hours +/- 15
             minutes

          -  Understand the pain rating scales (as judged by the study coordinator)

          -  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 form (ICF) 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 sodium, acetaminophen, Non Steroidal
             Anti-inflammatory Drugs (NSAIDS), aspirin, hydrocodone, similar pharmacological agents
             or components of the investigational 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 gastrointestinal bleeding or other 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

          -  Use of any Over-the-Counter (OTC) or prescription medications with which the
             administration of naproxen, acetaminophen, ibuprofen or any other NSAIDs, Lortab, is
             contraindicated or use of any medications within 5 days of surgery (except oral
             contraceptives, prophylactic antibiotics or medications to treat benign conditions
             such as antibiotics to treat acne)

          -  Females who are pregnant or lactating

          -  Habituation to analgesic drugs (i.e., routine use of oral analgesics 5 or more times
             per week for greater than 3 weeks)

          -  Alcoholism or drug abuse within 2 years prior to the Screening Visit or routine
             consumption of 3 or more alcohol containing beverages per day

          -  Positive urine, alcohol or nicotine test on day of surgery

          -  Smokers or using nicotine replacement therapies including transdermal patches, spray,
             lozenges or gum