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

Phase 3

Terminated

• Conditions: Laparoscopic Surgery
• Interventions: Drug: N1539; Drug: Ketorolac Tromethamine; Drug: Placebo

• Registration Number: NCT01436032
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-15
• Study First Submitted QC: 2011-09-16
• Study First Posted: 2011-09-19
• Study Start: 2011-10
• Status Verified: 2012-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Disposition First Submitted: 2012-03-12
• Disposition First Submitted QC: 2012-03-12
• Last Update Submitted: 2012-03-12
• Disposition First Posted: 2012-03-14
• Last Update Posted: 2012-03-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N1539 30 mg	N1539	-
N1539 15 mg	N1539	-
Ketorolac	Ketorolac Tromethamine	IV
Placebo	Placebo	IV
N1539 7.5mg	N1539	-

Primary Outcome Measures

Name	Time	Method
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)	0 to 24 hours

Trial Locations

Locations (1)

Lotus Clinical Research LLC; 🇺🇸 Pasadena, California, United States