Clinical trial NCT01084161: Study to Evaluate the Efficacy, Safety and Tolerability of N1539
Official title: A Randomized Double-Blind, Placebo- and Active-Controlled, Dose-Ranging Study to Evaluate the Analgesic, Efficacy, Safety and Tolerability of Intravenous N1539 in Subjects After Open Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hysterectomy
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-10
Enrollment: 486
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the analgesic efficacy, duration of effect, and safety of single doses of N1539 in subjects undergoing open abdominal hysterectomy


Eligibility criteria: Inclusion Criteria:

* moderate to severe pain with VAS of \>/= 45 mm
* undergo open abdominal hysterectomy
* ASA I or II
* signed ICF
* BMI \>18.5 and \< 31.5 kg/m\^2

Exclusion Criteria:

* suspected metastatic cervical or endometrial cancer
* 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

Primary outcomes:
measure: To determine the analgesic efficacy, duration of effect and safety of single doses of IV N1539 as measured by the SPID (summary of pain intensity) and TOPAR (summary of the time-weighted pain relief scores) from 0-24 hours.
timeFrame: at 60 minutes post dose and at 24 hours
Secondary outcomes:
measure: To assess the safety and tolerability of IV N1539 by laboratory data, vital signs, wound site evaluation and Adverse Events
timeFrame: 5-7 days post initial dosing
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
city: Tbilisi
country: Georgia
city: Tblisi
country: Georgia
city: Bialystok
country: Poland
city: Gdansk
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Ruda Slaska
country: Poland
city: Szczecin
country: Poland
city: Belgrade
country: Serbia
city: Kragujevac
country: Serbia
city: Novi Sad
country: Serbia
Study officials:
References:
citation: 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.
citation: 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.