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OMS103HP

Phase 3

Anterior Cruciate Ligament Reconstruction | Small molecule | Musculoskeletal |Omeros Corporation|Last Updated: Oct 12, 2012

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment480
FDA Designations
No designations recorded
Clinical trial landscape

OMS103HP · 4 trials · 3 indications

Phase 3 3Phase 2 1
NCT00226772Efficacy and Safety of OMS103HP in Patients Undergoing Autograft Anterior Cruciate Ligament (ACL) ReconstructionKnee Injuries
COMPLETED326 Analytics
NCT00226759Efficacy and Safety of OMS103HP in Patients Undergoing Allograft Anterior Cruciate Ligament (ACL) ReconstructionKnee Injuries
COMPLETED321 Analytics
NCT00245271Safety of OMS103HP in Patients Undergoing Anterior Cruciate Ligament (ACL) ReconstructionAnterior Cruciate Ligament Reconstruction
COMPLETED480 Analytics
PHASE3COMPLETED
Efficacy and Safety of OMS103HP in Patients Undergoing Autograft Anterior Cruciate Ligament (ACL) Reconstruction
Knee Injuries
NCT00226772326
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PHASE3COMPLETED
Efficacy and Safety of OMS103HP in Patients Undergoing Allograft Anterior Cruciate Ligament (ACL) Reconstruction
Knee Injuries
NCT00226759321
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PHASE3COMPLETED
Safety of OMS103HP in Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction
Anterior Cruciate Ligament Reconstruction
NCT00245271480
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Study Endpoints
Primary Endpoints
Improvement in knee function
30 days
The overall incidence of adverse events regardless of relationship to study drug.
90 days
The primary efficacy endpoint is the mean VAS at 24 hours postoperatively.
24 hours
Secondary Endpoints
Decreased pain
30 days
Improved range of motion
30 days
Earlier return to work
30 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
OMS103HP irrigation solutionEXPERIMENTALDrug
vehicle irrigation solutionPLACEBO_COMPARATORVehicle
1EXPERIMENTALOMS103 Irrigation Solution
2PLACEBO_COMPARATORBalanced Salt Solution (BSS)
DrugEXPERIMENTAL -
VehiclePLACEBO_COMPARATOR -
Interventions
NameTypeDescription
OMS103HPDRUGMaximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours
VehicleDRUGMaximum of 39 liters of vehicle irrigation solution over a maximum of 2 hours
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Eligibility Criteria
Age Range15 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * 15 - 65 years of age * In good general health with an ACL tear that occurred from 2 weeks to 18 months prior to the day of arthroscopic surgery * Undergoing primary unilateral ACL reconstruction using a medial hamstring (semitendinosus and gracilis) autograft * Able to partici...

Countries:United StatesCanada
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