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Completed

NCT Number: NCT01084161

Study to Evaluate the Efficacy, Safety and Tolerability of N1539

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

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Key information

Conditions

Hysterectomy

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Tbilisi, Georgia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N1539

Drug

5 mg IV once per day

Placebo

Drug

IV placebo once per day

Morphine

Drug

morphine 10-15 mg IV once per day

Primary outcomes

  1. 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

    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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 10, 2010
Registry last updated
Dec 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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