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Study to Evaluate the Efficacy, Safety and Tolerability of N1539

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alkermes
ClinicalTrials.gov Identifier:
NCT01084161
First received: March 5, 2010
Last updated: November 28, 2011
Last verified: November 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Hysterectomy
 Drug: N1539
Drug: placebo
Drug: Morphine
 Phase 2

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
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

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Further study details as provided by Alkermes:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 486
Study Start Date: March 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: N1539 5 mg Drug: N1539
5 mg IV once per day
Experimental: N1539 7.5 mg Drug: N1539
7.5 mg IV once per day
Experimental: N1539 15 mg Drug: N1539
15 mg IV once per day
Experimental: N1539 30 mg Drug: N1539
30 mg IV once per day
Experimental: N1539 60 mg Drug: N1539
60 mg IV once per day
Placebo Comparator: Placebo Drug: placebo
IV placebo once per day
Active Comparator: morphine Drug: Morphine
morphine 10-15 mg IV once per day

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084161

Locations
Georgia
Tbilisi, Georgia, 0186
Tbilisi, Georgia, 0159
Tblisi, Georgia, 0186
Poland
Bialystok, Poland, 15-276
Gdansk, Poland, 80-402
Lodz, Poland, 94-029
Lublin, Poland, 20-081
Poznan, Poland, 60-535
Ruda Slaska, Poland, 41-703
Szczecin, Poland, 70-111
Serbia
Belgrade, Serbia, 11000
Kragujevac, Serbia, 34000
Novi Sad, Serbia, 21000
Sponsors and Collaborators
Alkermes
  More Information

No publications provided

Responsible Party: Alkermes
ClinicalTrials.gov Identifier: NCT01084161     History of Changes
Other Study ID Numbers: N1539-04
Study First Received: March 5, 2010
Last Updated: November 28, 2011
Health Authority: United States: Food and Drug Administration
Georgia: Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Poland: Ministry of Health

Additional relevant MeSH terms:
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on June 18, 2013