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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Laparoscopic Surgery

In brief

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

Key facts

Study ID

NCT01436032

Run by

Alkermes, Inc.

People needed

50

Starts

2011-10-01

Expected to finish

2012-03-01

Last updated by the study team

2012-03-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Planning to undergo elective abdominal laparoscopic surgery involving a single site/organ and does not have intraperitoneal metastases suspected or identified

You may not qualify if…

• 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

Where it is running

• Lotus Clinical Research LLC — Pasadena, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.