Study to Evaluate the Efficacy, Safety and Tolerability of N1539
NCT ID: NCT01084161
Last Updated: 2011-12-02
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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COMPLETED
PHASE2
486 participants
INTERVENTIONAL
2010-03-31
2011-01-31
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
TRIPLE
Study Groups
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N1539 5 mg
N1539
5 mg IV once per day
N1539 7.5 mg
N1539
7.5 mg IV once per day
N1539 15 mg
N1539
15 mg IV once per day
N1539 30 mg
N1539
30 mg IV once per day
N1539 60 mg
N1539
60 mg IV once per day
Placebo
placebo
IV placebo once per day
morphine
Morphine
morphine 10-15 mg IV once per day
Interventions
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N1539
5 mg IV once per day
N1539
7.5 mg IV once per day
N1539
15 mg IV once per day
N1539
30 mg IV once per day
placebo
IV placebo once per day
Morphine
morphine 10-15 mg IV once per day
N1539
60 mg IV once per day
Eligibility Criteria
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Inclusion Criteria
* undergo open abdominal hysterectomy
* ASA I or II
* signed ICF
* BMI \>18.5 and \< 31.5 kg/m\^2
Exclusion Criteria
* prior abdominal surgery with postoperative complications
* active pancreatitis, obstruction of biliary tree or total bilirubin\> 2.5 mg/dL
* active GI bleeding, or peptic ulcer disease
* unstable medical condition
* HbA1c \>9.5 or uncontrolled diabetes
* SBP \>150 mmHg or DBP \> 95 mmHg
* personal or familial contraindication to undergoing general anesthesia
* Antihypertensive agents or diabetic regimen that is not stable (4 weeks prior to surgery)
* taking CNS agents for pain
* acetaminophen or NSAIDs not discontinued for at least 5 half-lives prior to planned surgery
* currently taking an opioid or has taken an opioid chronically for pain in past 2 years
* corticosteroid or systemic corticosteroids within 6 weeks of planned surgery
* has a known bleeding disorder or taking agents affecting coagulation
* history of intolerance or allergic reactions to NSAIDs, COX-2 inhibitors, aspirin and other salicylates
* receiving lithium or a combination of furosemide with an ACE inhibitor or angiotensin receptor blocker
* Known to have sleep apnea
* History of hepatitis B or C
* AST or ALT \> 2 times the upper limit of normal
* Known or suspected COPD with retention of carbon dioxide
* psychiatric condition that impairs the capability of the subject to report pain
18 Years
65 Years
FEMALE
No
Sponsors
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Alkermes, Inc.
INDUSTRY
Responsible Party
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Locations
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Tbilisi, , Georgia
Tbilisi, , Georgia
Bialystok, , Poland
Gdansk, , Poland
Lodz, , Poland
Lublin, , Poland
Poznan, , Poland
Ruda Śląska, , Poland
Szczecin, , Poland
Belgrade, , Serbia
Kragujevac, , Serbia
Novi Sad, , Serbia
Countries
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References
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Rechberger T, Mack RJ, McCallum SW, Du W, Freyer A. Analgesic Efficacy and Safety of Intravenous Meloxicam in Subjects With Moderate-to-Severe Pain After Open Abdominal Hysterectomy: A Phase 2 Randomized Clinical Trial. Anesth Analg. 2019 Jun;128(6):1309-1318. doi: 10.1213/ANE.0000000000003920.
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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N1539-04
Identifier Type: -
Identifier Source: org_study_id