A Full-Factorial, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single-Dose Efficacy and Safety Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen, and Naproxen Sodium in Postoperative Dental Pain

CCSPAA005199

The purpose of this study is to evaluate how well a fixed combination of acetaminophen/naproxen sodium relieves postoperative dental pain compared with acetaminophen, naproxen sodium and placebo.

2023-05-22

2024-05-17

2024-05-31

Recruiting

Early phase I

440

Inclusion Criteria: * Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (inclusive) at screening * Surgical removal of three or four third molars, of which, two must be mandibular impactions * Meets requirements for post-surgical pain level * Females of childbearing potential and males agree to contraceptive requirements of study * Have a negative urine drug screen at screening, and on day of surgical procedure Exclusion Criteria: * Pregnant female, breastfeeding, trying to become pregnant or male with pregnant partner or partner currently trying to become pregnant * Have a known allergy or hypersensitivity to naproxen (or other NSAIDs including aspirin) or to acetaminophen, oxycodone or other opioids * Not able to swallow whole large tablets or capsules * History of any condition(s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study * Use analgesics 5 or more times per week * History of chronic tranquilizer use, heavy drinking, or substance abuse, as judged by the investigator site staff, in the last 5 years * Use any immunosuppressive drugs within 2 weeks of surgical procedure * History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Postoperative dental pain following third molar extraction.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 440, 'type': 'ESTIMATED'}}

2024-05-08