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

Laparoscopic Surgery Clinical Trial

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01436032
• Other study ID #: N1539-05
• Status: Terminated
• Phase: Phase 3
• First received: September 15, 2011
• Last updated: March 12, 2012
• Start date: October 2011
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laparoscopic Surgery

Intervention

Drug:
• N1539
IV
• N1539
IV
• N1539
IV
• Ketorolac Tromethamine
IV
• Placebo
IV

Locations

Country	Name	City	State
United States	Lotus Clinical Research LLC	Pasadena	California

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No