Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study
Condition: Pain
Intervention: 440 mg naproxen sodium with 1000 mg acetaminophen; 220 mg naproxen sodium with 650 mg acetaminophen; 10 mg hydrocodone + 650 mg acetaminophen; 440 mg naproxen sodium; Placebo tablet
Intervention description: 440 mg naproxen sodium with 1000 mg acetaminophen administered as a single dose of two naproxen sodium 220 mg tablets and two acetaminophen 500 mg tablets; 220 mg naproxen sodium with 650 mg acetaminophen administered as a single dose of one naproxen sodium 220 mg tablet and two acetaminophen 325 mg tablets and one placebo tablet; 10 mg hydrocodone with 650 mg acetaminophen administered as a single dose of two hydrocodone 5 mg + acetaminophen 325 mg tablets and two placebo tablets; 440 mg naproxen sodium administered as a single dose of two naproxen sodium 220 mg tablets and two placebo tablets; Single dose of four placebo tablets
Intervention MeSH terms: Acetaminophen; Naproxen; Acetaminophen, hydrocodone drug combination; Hydrocodone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Post-operative dental pain following third molar extraction.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 290.0
Sex: All
Minimum age: 17 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Analgesics; Dental Pain; Naproxen; Acetaminophen; Pain

Summary:

      Study assessing efficacy and safety of concomitantly dosed naproxen sodium with
      acetaminophen, compared with naproxen sodium, hydrocodone/acetaminophen and Placebo in a
      postoperative dental pain.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males of females 17-50 years old

          2. Weigh 100 pounds or greater and have a body mass index (BMI) of 18.5 to 35 (inclusive)
             at screening

          3. Surgical removal of up to four third molars, of which, two must be mandibular
             impactions

          4. Meets requirements for post -surgical pain level

          5. Females of childbearing potential and males agree to contraceptive requirements of
             study

          6. Have a negative urine drug screen at screening, and on day of surgical procedure

        Exclusion Criteria:

          1. Pregnant female, breastfeeding, trying to become pregnant or male with pregnant
             partner or partner currently trying to become pregnant

          2. Have known allergy or hypersensitivity to naproxen or other NSAIDS, including aspirin,
             or to acetaminophen, tramadol, hydrocodone or other opioids

          3. Not able to swallow large tablets or capsules

          4. History of any condition (s) in investigator's opinion, may jeopardize subject safety,
             well-being and integrity of study

          5. Use analgesics 5 or more times per week

          6. History of chronic tranquilizer use, heavy drinking, substance abuse as judged by
             investigator site staff within last 5 years

          7. Use of immunosuppressive drugs within 2 weeks of screening

          8. History of peptic ulcer disease or gastrointestinal bleeding in the last two years or
             hematologic bleeding