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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 InjuriesUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety of OMS103HP in Patients Undergoing Allograft Anterior Cruciate Ligament (ACL) Reconstruction
Knee InjuriesUnlock trial analytics
PHASE3COMPLETED
Safety of OMS103HP in Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction
Anterior Cruciate Ligament ReconstructionUnlock trial analytics

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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Frequently asked questions about OMS103HP

What is OMS103HP used for?

OMS103HP is an investigational small molecule being studied for use in anterior cruciate ligament reconstruction, knee injuries, and postoperative pain. It is administered as an irrigation solution during knee surgery. The drug is developed by Omeros Corporation and is currently in Phase 3 clinical development.

What does OMS103HP target?

OMS103HP is a small molecule that targets multiple pathways involved in inflammation and pain. It is designed to be used as an irrigation solution during knee surgeries to reduce postoperative pain and improve recovery. The drug is being studied in patients undergoing ACL reconstruction and meniscectomy procedures.

Who makes OMS103HP?

OMS103HP is developed by Omeros Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol OMER. The company is conducting clinical trials to evaluate the safety and efficacy of OMS103HP for knee surgery-related indications.

What phase is OMS103HP in?

OMS103HP is in Phase 3 clinical development. It has completed multiple Phase 3 trials in patients undergoing anterior cruciate ligament reconstruction, including both allograft and autograft procedures. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is OMS103HP in?

OMS103HP has completed several clinical trials, including NCT00226759 and NCT00226772, which were Phase 3 studies in patients undergoing allograft and autograft ACL reconstruction, respectively. Another Phase 3 trial, NCT00245271, evaluated safety in ACL reconstruction patients. A Phase 2 trial, NCT00624845, studied the drug in meniscectomy patients.

Is OMS103HP the same as any other drug?

OMS103HP is a unique investigational drug developed by Omeros Corporation. It is not known to be the same as any other approved medication. The drug is being studied specifically as an irrigation solution for use during knee surgeries to address postoperative pain and inflammation.