Hysterectomy
Conditions
Brief summary
To determine the analgesic efficacy, duration of effect, and safety of single doses of N1539 in subjects undergoing open abdominal hysterectomy
Interventions
DRUGN1539
5 mg IV once per day
DRUGplacebo
IV placebo once per day
DRUGMorphine
morphine 10-15 mg IV once per day
Sponsors
Alkermes, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | at 60 minutes post dose and at 24 hours | Additionally, to determine the efficacy seen within the first hour after study drug administration, as measured by the SPID 0-60 minutes post-dose. |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of IV N1539 by laboratory data, vital signs, wound site evaluation and Adverse Events | 5-7 days post initial dosing |
Countries
Georgia, Poland, Serbia
Outcome results
None listed