Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic Surgery
NCT ID: NCT01436032
Last Updated: 2012-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
50 participants
INTERVENTIONAL
2011-10-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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N1539 15 mg
N1539
IV
N1539 30 mg
N1539
IV
Ketorolac
IV
Ketorolac Tromethamine
IV
Placebo
IV
Placebo
IV
N1539 7.5mg
N1539
IV
Interventions
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N1539
IV
N1539
IV
N1539
IV
Ketorolac Tromethamine
IV
Placebo
IV
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Alkermes, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Neil Singla, MD
Role: PRINCIPAL_INVESTIGATOR
Lotus Clinical Research, LLC
Locations
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Lotus Clinical Research LLC
Pasadena, California, United States
Countries
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References
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Viscusi ER, Gan TJ, Bergese S, Singla N, Mack RJ, McCallum SW, Du W, Hobson S. Intravenous meloxicam for the treatment of moderate to severe acute pain: a pooled analysis of safety and opioid-reducing effects. Reg Anesth Pain Med. 2019 Mar;44(3):360-368. doi: 10.1136/rapm-2018-100184. Epub 2019 Feb 7.
Other Identifiers
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N1539-05
Identifier Type: -
Identifier Source: org_study_id
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