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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
History of Changes
  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:

U.S. FDA Resources

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 June 18, 2013