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

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ClinicalTrials.gov Identifier: NCT01436032
Recruitment Status : Terminated
First Posted : September 19, 2011
Last Update Posted : March 14, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Laparoscopic Surgery Drug: N1539 Drug: Ketorolac Tromethamine Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01436032


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

Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT01436032     History of Changes
Other Study ID Numbers: N1539-05
First Posted: September 19, 2011    Key Record Dates
Last Update Posted: March 14, 2012
Last Verified: March 2012

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