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Study to Evaluate the Efficacy, Safety and Tolerability of N1539

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01084161
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : December 2, 2011
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Hysterectomy Drug: N1539 Drug: placebo Drug: Morphine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 486 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : March 2010
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084161

Tbilisi, Georgia, 0159
Tbilisi, Georgia, 0186
Tblisi, Georgia, 0186
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
Belgrade, Serbia, 11000
Kragujevac, Serbia, 34000
Novi Sad, Serbia, 21000
Sponsors and Collaborators
Alkermes, Inc.

Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT01084161     History of Changes
Other Study ID Numbers: N1539-04
First Posted: March 10, 2010    Key Record Dates
Last Update Posted: December 2, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents