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

MLI-RD85-P2-2023

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

2023-07-01

2023-12-01

2024-02-01

Not yet recruiting

Early phase I

108

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.

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2023-07-18