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Loxoprofen Pain Patch

Phase 2

Delayed Onset Muscle Soreness | Small molecule | Other |Cardinal Health, Inc.|Last Updated: Oct 28, 2016

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 Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02602353Pilot Study Comparing the Efficacy and Safety of a New Pain Patch and Placebo in Delayed Onset Muscle Soreness (DOMS)PHASE2 COMPLETED 42 — — Oct 1, 2015Dec 1, 2015Oct 28, 20161 United States
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Study Endpoints
Primary Endpoints
Sum of pain intensity differences over 24 hours from baseline (SPID 24) with movement
0-24 hours
Secondary Endpoints
Sum of pain intensity differences over 24 hours from baseline (SPID 24) at rest
0-24 hours
Sum of pain intensity differences over 48 hours from baseline (SPID 48) with movement
0-48 hours
Sum of pain intensity differences over 48 hours from baseline (SPID 48) at rest
0-48 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Loxoprofen Pain PatchEXPERIMENTALOne Active Pain Patch containing loxoprofen applied once daily for 3 days
Placebo PatchPLACEBO_COMPARATOROne Placebo Patch applied once daily for 3 days
No TreatmentOTHERNo Treatment for 3 days
Interventions
NameTypeDescription
Loxoprofen Pain PatchDRUGOne Loxoprofen Pain Patch (active NSAID) applied once daily for 3 days
Placebo PatchDRUGOne Placebo Patch applied daily for 3 days
No TreatmentDRUGNo Treatment for 3 days
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Males or females, 18 to 40 years of age * are in good general health, with a BMI less than or equal to 32, and able to perform the exercise regimen * develops muscle pain/soreness within 24-48 hours of the end of the exercise regimen and have a baseline muscle pain/soreness wi...

Countries:United States
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