Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic Surgery

A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Analgesic Efficacy, Safety and Tolerability of Intravenous N1539 in Subjects After Abdominal Laparoscopic Surgery

The purpose of this study is to determine the analgesic efficacy and safety of N1539 in subjects undergoing abdominal laparoscopic surgery.

Inclusion Criteria:

• Planning to undergo elective abdominal laparoscopic surgery involving a single site/organ and does not have intraperitoneal metastases suspected or identified

Exclusion Criteria:

• Use of ketorolac is contraindicated
• Use of general anesthesia is contraindicated
• Has a medical condition that could adversely impact subject participation
• Has diabetes mellitus and glycosylated hemoglobin (HbA1c) >9.5 or history of prolonged uncontrolled diabetes
• Body mass index (BMI) less than 18 or greater than 35
• Has a history of intolerance or allergic reactions to non-steroidal anti-inflammatory drugs (NSAIDs), Cox-2 inhibitors, aspirin or other salicylates
• Known or suspected sleep apnea
• History of Hepatitis B or C
• Has a psychiatric disorder that impairs capability of subject to report pain
• Known to have chronic obstructive pulmonary disease (COPD) with carbon dioxide retention or chronic hypoxemia