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

• Status: Terminated
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Ketorolac; Ketorolac Tromethamine

Criteria

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