Efficacy, Safety and Tolerability Study of Meloxicam Injection in Subjects After Abdominal Surgery

A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Analgesic Efficacy, Safety and Tolerability of Meloxicam Injection in Subjects After Abdominal Surgery

The purpose of this study is to determine the analgesic efficacy and safety of Meloxicam Injection in subjects undergoing abdominal surgery.

Inclusion Criteria:

Voluntarily provide written informed consent. Be scheduled to undergo elective abdominoplasty surgery without collateral procedures.

Be American Society of Anesthesiology (ASA) physical class 1 or 2. Male or female between 18 and 70 years of age, inclusive. Have a body mass index 18~30 kg/m2. Be able to understand the study procedures, comply with all study procedures, and agree to participate in the study program.

Exclusion Criteria:

Have a history of abdominoplasty surgery within the preceding 12 months. Have active or recent (within 6 months) gastrointestinal ulceration or bleeding.

Have a history of myocardial infarction or coronary artery bypass graft surgery within the preceding 12 months.

Have a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study.

Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants.

Have another painful physical condition that may confound the assessments of post operative pain.

Have a history of advanced malignant tumor. Have a history of alcohol abuse (regularly drinks > 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) within the past 5 years or a history of prescription/illicit drug abuse.

Have positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse.

Have evidence of a clinically significant 12 lead ECG abnormality. Have a clinically significant abnormal clinical laboratory test value. Have history of or positive test results for HIV, treponema pallidum,or hepatitis B or C.

Have a known allergy to meloxicam or any excipient of N1539, D5W, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs) or to any peri- or postoperative medications used in this study.

Have been receiving or have received chronic opioid therapy defined as greater than 15 morphine equivalents units per day for greater than 3 out of 7 days per week over a one-month period within 12 months of surgery.