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Etodolac-lidocaine patch

Phase 3

Acute Delayed Onset Muscle Soreness (DOMS) | Small molecule | Other |BrainsWay Ltd.|Last Updated: Sep 12, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

Etodolac-lidocaine patch · 1 trial · 1 indication

Phase 3 1
NCT02695381Etodolac-lidocaine Patch in Subjects Experiencing Acute Delayed Onset Muscle SorenessAcute Delayed Onset Muscle Soreness (DOMS)
COMPLETED100 Analytics
PHASE3COMPLETED
Etodolac-lidocaine Patch in Subjects Experiencing Acute Delayed Onset Muscle Soreness
Acute Delayed Onset Muscle Soreness (DOMS)
NCT02695381100
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Study Endpoints

Primary Endpoints

Sum of the time-weighted differences from baseline in pain intensity with movement (SPIDMove) over 0-24 hours post-T0 (SPIDMove 0-24 hours).
24 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelFACTORIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Etodolac-lidocaine Topical PatchEXPERIMENTALTherapy with experimental drug
PlaceboPLACEBO_COMPARATORTherapy with placebo

Interventions

NameTypeDescription
Etodolac-lidocaine topical patchDRUGOnce daily
PlaceboDRUGOnce daily
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Eligibility Criteria

Age Range18 Years to 35 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Have not engaged in significant upper extremity fitness activities for more than two times per week for ≥ 2 consecutive weeks in the past 6 months prior to screening. * Subject has a body mass index of between 18 and 30 kg/m2, inclusive. * Subjects who report a pain with movem...

Countries:United States
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