Status:
TERMINATED
Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic Surgery
Lead Sponsor:
Alkermes, Inc.
Conditions:
Laparoscopic Surgery
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the analgesic efficacy and safety of N1539 in subjects undergoing abdominal laparoscopic surgery.
Eligibility Criteria
Inclusion
- Planning to undergo elective abdominal laparoscopic surgery involving a single site/organ and does not have intraperitoneal metastases suspected or identified
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01436032
Start Date
October 1 2011
End Date
March 1 2012
Last Update
March 14 2012
Active Locations (1)
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1
Lotus Clinical Research LLC
Pasadena, California, United States, 91105