Study to Evaluate the Efficacy, Safety and Tolerability of N1539

Phase 2

Completed

• Conditions: Hysterectomy
• Interventions: Drug: N1539; Drug: placebo; Drug: Morphine

• Registration Number: NCT01084161
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-05
• Study First Submitted QC: 2010-03-09
• Study First Posted: 2010-03-10
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Disposition First Submitted: 2011-06-24
• Status Verified: 2011-11
• Disposition First Submitted QC: 2011-11-28
• Last Update Submitted: 2011-11-28
• Disposition First Posted: 2011-12-02
• Last Update Posted: 2011-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 486

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N1539 5 mg	N1539	-
Placebo	placebo	-
N1539 7.5 mg	N1539	-
N1539 15 mg	N1539	-
N1539 30 mg	N1539	-
N1539 60 mg	N1539	-
morphine	Morphine	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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