Study to Evaluate the Efficacy, Safety and Tolerability of N1539

Alkermes

Status and phase: Completed; Phase 2

Conditions: Hysterectomy

Treatments: Drug: N1539; Drug: placebo; Drug: Morphine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01084161

N1539-04

Details and patient eligibility

About

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

Enrollment: 486 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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486 participants in 7 patient groups, including a placebo group

N1539 5 mg

Experimental group

Treatment:

Drug: N1539

Drug: N1539

Drug: N1539

Drug: N1539

Drug: N1539

N1539 7.5 mg

Experimental group

Treatment:

Drug: N1539

Drug: N1539

Drug: N1539

Drug: N1539

Drug: N1539

N1539 15 mg

Experimental group

Treatment:

Drug: N1539

Drug: N1539

Drug: N1539

Drug: N1539

Drug: N1539

N1539 30 mg

Experimental group

Treatment:

Drug: N1539

Drug: N1539

Drug: N1539

Drug: N1539

Drug: N1539

N1539 60 mg

Experimental group

Treatment:

Drug: N1539

Drug: N1539

Drug: N1539

Drug: N1539

Drug: N1539

Placebo

Placebo Comparator group

Treatment:

Drug: placebo

morphine

Active Comparator group

Treatment:

Drug: Morphine