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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Alkermes
ClinicalTrials.gov Identifier:
NCT01436032
First received: September 15, 2011
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Laparoscopic Surgery
Drug: N1539
Drug: Ketorolac Tromethamine
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Alkermes:

Primary Outcome Measures:
  • 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) [ Time Frame: 0 to 24 hours ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: October 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: N1539 15 mg Drug: N1539
IV
Experimental: N1539 30 mg Drug: N1539
IV
Active Comparator: Ketorolac
IV
Drug: Ketorolac Tromethamine
IV
Placebo Comparator: Placebo
IV
Drug: Placebo
IV
Experimental: N1539 7.5mg Drug: N1539
IV

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436032

Locations
United States, California
Lotus Clinical Research LLC
Pasadena, California, United States, 91105
Sponsors and Collaborators
Alkermes
Investigators
Principal Investigator: Neil Singla, MD Lotus Clinical Research, LLC
  More Information

No publications provided

Responsible Party: Alkermes
ClinicalTrials.gov Identifier: NCT01436032     History of Changes
Other Study ID Numbers: N1539-05
Study First Received: September 15, 2011
Last Updated: March 12, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ketorolac Tromethamine
Ketorolac
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014