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Sponsor: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Conditions: Post-operative Dental Pain
Interventions: Test naproxen sodium tablet, Commercial naproxen sodium tablet, Commercial naproxen sodium liquid gels capsule, Placebo tablet
Countries: United States
To evaluate analgesic onset, efficacy, and safety of a single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets compared with two commercial naproxen sodium products (two naproxen sodium 220 mg tablets and two naproxen sodium 220 mg liquid gels capsules) and placebo in the dental pain model following third-molar extractions.
Sex: ALL
Age: 17 Years to 50 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: 1. 17 - 50 years old 2. Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (inclusive) at screening 3. Dental extraction of three or four third molars 4. Meets post-surgical pain 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 be pregnant or male with pregnant partner or partner currently trying to become pregnant 2. Have a known allergy or hypersensitivity to naproxen or other NSAIDs, including aspirin, or to acetaminophen, 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 endoscopically documented peptic ulcer disease or bleeding disorder in last 2 years
- Salt Lake City, Utah, United States