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PMI-150

Phase 3

Pain, Postoperative | Small molecule | Pain |Pfizer, Inc.|Last Updated: Jan 11, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment250
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00709436Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic SurgeryPHASE3 COMPLETED 250 — — Jun 1, 2008Aug 1, 2011Jan 11, 201216 United States
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Study Endpoints
Primary Endpoints
Measures of pain intensity difference
0-6 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALPMI-150 (intranasal ketamine) at time 0 and specified time points thereafter.
2PLACEBO_COMPARATORPlacebo at time 0 and specified time points thereafter.
Interventions
NameTypeDescription
PMI-150 (intranasal ketamine)DRUGPMI-150 (intranasal ketamine) at time 0 and scheduled times thereafter.
PlaceboDRUGPlacebo (intranasal) at time 0 and scheduled times thereafter.
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * patient is scheduled for elective orthopedic surgery or procedure Exclusion Criteria: * patient has received an investigational drug or participated in a clinical trial within 30 days or 5 half-lives (whichever is longer) of entering this study

Countries:United States
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