The purpose of this study is to determine the analgesic efficacy and safety of N1539 in
subjects undergoing abdominal laparoscopic surgery.
Drug: Ketorolac Tromethamine
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Full eligibility criteria for NCT01436032
Ages eligible for Study
18 Years to 80 Years
Genders 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
All locations for NCT01436032
United States (1)
Lotus Clinical Research LLC
Pasadena, California, United States, 91105
View full eligibility
Tris trial is registered with FDA with number: NCT01436032. The sponsor of the trial is Alkermes, Inc. and it is looking for 50 volunteers for the current phase.
Official trial title: A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Analgesic Efficacy, Safety and Tolerability of Intravenous N1539 in Subjects After Abdominal Laparoscopic Surgery
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