Study to Evaluate the Efficacy, Safety and Tolerability of N1539

Hysterectomy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084161
• Other study ID #: N1539-04
• Status: Completed
• Phase: Phase 2
• First received: March 5, 2010
• Last updated: November 28, 2011
• Start date: March 2010
• Est. completion date: January 2011

Study information

• Verified date: November 2011
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGeorgia: Ministry of HealthSerbia and Montenegro: Agency for Drugs and Medicinal DevicesPoland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 486
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hysterectomy

Intervention

Drug:
• N1539
5 mg IV once per day
• N1539
7.5 mg IV once per day
• N1539
15 mg IV once per day
• N1539
30 mg IV once per day
• placebo
IV placebo once per day
• Morphine
morphine 10-15 mg IV once per day
• N1539
60 mg IV once per day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Countries where clinical trial is conducted

Georgia,  Poland,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Additionally, to determine the efficacy seen within the first hour after study drug administration, as measured by the SPID 0-60 minutes post-dose.	at 60 minutes post dose and at 24 hours	No
Secondary	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	Yes