Study to Evaluate the Efficacy, Safety and Tolerability of N1539

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01084161
• Date of registration: 05/03/2010
• Prospective Registration: No
• Primary sponsor: Alkermes, Inc.
• Public title: Study to Evaluate the Efficacy, Safety and Tolerability of N1539
• Scientific 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
• Date of first enrolment: March 2010
• Target sample size: 486
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01084161
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Georgia, Poland, Serbia

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Hysterectomy

Intervention(s)

Drug: placebo

Drug: N1539

Drug: Morphine

Primary Outcome(s)

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. [Time Frame: at 60 minutes post dose and at 24 hours]

Secondary Outcome(s)

To assess the safety and tolerability of IV N1539 by laboratory data, vital signs, wound site evaluation and Adverse Events [Time Frame: 5-7 days post initial dosing]

Secondary ID(s)

N1539-04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors