Study to Collect Information on How Well the Study Drug Naproxen Sodium Tablets Works Compared to Hydrocodone/Acetaminophen Tablets in Order to Relieve Pain in Participants Experiencing Moderate to Severe Pain After Having Their Wisdom Teeth Removed
Condition: Pain
Intervention: Naproxen Sodium (Aleve, BAY117031); Hydrocodone/Acetaminophen; Placebo
Intervention description: 220 mg per tablet, two tablets (440 mg), intake a single dose orally.; 5/325 mg per tablet, two tablets (10/650 mg), intake a single dose orally.; two tablets, intake a single dose orally.
Intervention MeSH terms: Acetaminophen; Naproxen; Acetaminophen, hydrocodone drug combination; Hydrocodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 221.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Postsurgical Dental Pain

Summary:

      With this study researchers want to collect information on how long the pain relief lasts
      after a fixed dose of naproxen sodium or hydrocodone/acetaminophen or placebo (contains no
      medication) over 12 hours in subjects experiencing moderate to severe pain after having their
      wisdom teeth removed. Naproxen Sodium (Aleve®) is a drug that is used for the temporary
      relief of minor aches and pains.

      Hydrocodone/Acetaminophen is a combination drug used to relieve moderate to severe pain. It
      contains an opioid (narcotic) pain reliever (hydrocodone) and a non-opioid pain reliever
      (acetaminophen).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, ambulatory, male or female volunteers 18 to 40 years of age;

          -  Subjects will undergo surgical extraction of three or four third molars, two of which
             must be mandibular molars. Maxillary third molars may be removed regardless of
             impaction level. The mandibular extractions must have a trauma rating of mild or
             moderate and meet one of the following scenarios:

               -  two full bony impactions

               -  two partial bony impactions

               -  one full bony impaction in combination with one partial bony impaction
                  Supernumerary teeth present may also be removed at the discretion of the oral
                  surgeon;

          -  Have not consumed alcoholic beverages, or foods and beverages containing caffeine
             (examples; coffee, tea, chocolate, and colas) after midnight prior to surgery and
             agree not to consume any of these foods or beverages throughout their stay at the
             study site;

          -  Use of only short-acting local anesthetic (e.g., mepivacaine or lidocaine)
             preoperatively, with or without a vasoconstrictor and nitrous oxide at the discretion
             of the Investigator;

          -  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 ≥ 5 on the 0-10 pain intensity
             NRS within 4.5 hours postsurgery;

          -  Ability to understand and follow study-related instructions;

          -  Be willing and able to participate in all scheduled visits, treatment plan, and trial
             procedures according to the clinical protocol;

        Exclusion Criteria:

          -  History of hypersensitivity to naproxen sodium, hydrocodone/acetaminophen, ibuprofen,
             NSAIDS, aspirin, similar pharmacological agents, local anesthetics, rescue medication
             or components of the investigational products;

          -  Evidence or history of clinically significant (in the judgment of the investigator)
             hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular
             (including hypertension), hepatic, psychiatric, neurologic diseases, or malignancies
             within the last 5 years;

          -  Subjects with the following medical conditions may be eligible at the discretion of
             the investigator: ADHD on a stable dose regimen of methylphenidate/(dextro)amphetamine
             for at least 6 months; subjects with hypothyroidism on a stable dose of synthetic
             thyroid hormone for at least 6 months;

          -  Have received any form of treatment in the form of medication for depression in the
             past 6 months or any form of psychotropic agent (including selective serotonin uptake
             inhibitors [SSRI] but excluding ADHD medications described above) within the last 6
             months;

          -  Use of any OTC or prescription medications with which the administration of naproxen,
             hydrocodone/acetaminophen, acetaminophen, ibuprofen, any other NSAID, (e.g., tramadol)
             or if a medication is contraindicated;

          -  Females who are planning to become pregnant, pregnant or lactating;

          -  Habituation to analgesic drugs including opioids (i.e., routine use of oral analgesics
             5 or more times per week for greater than 3 weeks within the past 2 years);

          -  Alcoholism or drug abuse within 2 years prior to the Screening Visit or routine
             consumption of 3 or more alcohol containing beverages per day; Alcohol containing
             beverages are defined as one beer (5%), one glass of wine (11%) and one shot (40%)
             hard liquor;

          -  Surgeon's trauma rating of severe following surgery;

          -  Unwilling or unable to comply with all requirements outlined in the protocol;