Evaluate Efficacy and Safety of Extended Release (ER) Naproxen Sodium (VERNE) - Trial 2014-005272-28

Timeline & Enrollment

Primary Outcome

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

ICD-10 Classifications