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N1539

Phase 2

Hysterectomy | Small molecule | Other |Alkermes plc|Last Updated: Dec 2, 2011

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment486
FDA Designations
No designations recorded
Clinical trial landscape

N1539 · 2 trials · 2 indications

Phase 2 2
NCT01084161Study to Evaluate the Efficacy, Safety and Tolerability of N1539Hysterectomy
COMPLETED486 Analytics
NCT00945763Single Dose Study of N1539 in the Treatment of Pain Secondary to Dental Impaction SurgeryDental Pain
COMPLETED230 Analytics
PHASE2COMPLETED
Study to Evaluate the Efficacy, Safety and Tolerability of N1539
Hysterectomy
NCT01084161486
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PHASE2COMPLETED
Single Dose Study of N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery
Dental Pain
NCT00945763230
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Study Endpoints
Primary Endpoints
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.
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.

Pain Intensity Difference at End of Study
0-24 hours
Secondary Endpoints
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
Onset of action
0-1 hour
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
N1539 5 mgEXPERIMENTAL -
N1539 7.5 mgEXPERIMENTAL -
N1539 15 mgEXPERIMENTAL -
N1539 30 mgEXPERIMENTAL -
N1539 60 mgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
morphineACTIVE_COMPARATOR -
MotrinACTIVE_COMPARATOR -
Interventions
NameTypeDescription
N1539DRUG5 mg IV once per day
placeboDRUGIV placebo once per day
MorphineDRUGmorphine 10-15 mg IV once per day
MotrinDRUG400 mg
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Eligibility Criteria
Age Range18 Years to 65 Years
SexFEMALE
Healthy VolunteersNo
Study Sites12

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 complicatio...

Countries:GeorgiaPolandSerbiaUnited States
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