Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic Surgery
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Sum of the time-weighted pain intensity differences (SPID) as recorded on the Visual Analog Scale (VAS) from baseline (time 0) to 24 hours following the first dose of study medication (SPID 24) [ Time Frame: 0 to 24 hours ]
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Planning to undergo elective abdominal laparoscopic surgery involving a single site/organ and does not have intraperitoneal metastases suspected or identified
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