Safety of OMS103HP in Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction

Study Overview
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Brief Summary
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OMS103HP is being developed for improvement in knee function following ACL reconstruction. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee motion and earlier return to work.

Detailed Description
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The anterior cruciate ligament (ACL) is an important stabilizer of the knee. Orthopedic surgeons replace the torn ligament during ACL reconstruction surgery. Surgical trauma initiates an acute inflammatory response, including swelling and pain, that leads to restricted joint motion and loss of function. Because of the dynamic nature, complexity and redundancy of the chemical mediators of inflammation and pain and their pathways, no currently available single drug has sufficiently broad spectrum of activity to effectively inhibit the inflammatory process. OMS103 provides a multicomponent approach to controlling the inflammation induced by arthroscopic surgery. It delivers three active ingredients, each with distinct pharmacological activities, directly to the site of surgical procedures to preemptively block the inflammatory cascade induced by surgical trauma.

Official Title
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Double-Blind, Multicenter Study Evaluating the Safety of OMS103HP and Vehicle in Subjects Undergoing Anterior Cruciate Ligament Reconstruction With an Open-Label Phase Containing a PK Analysis in a Subset of Subjects

Conditions
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Anterior Cruciate Ligament Reconstruction

Intervention / Treatment
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* Drug: OMS103HP
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 17 - 65 years of age In good general health Undergoing arthroscopic ACL reconstruction for an ACL tear Exclusion Criteria: Allergies to any of the individual ingredients in OMS103HP Has open physes in the distal femur or proximal tibia Undergoing bilateral knee surgery Subject who is considered by Investigator to be an unsuitable candidate

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>OMS103 Irrigation Solution | Drug: OMS103HP<br>* Maximum of 13 bags of OMS103HP irrigation solution over a maximum of 2 hours<br>|
| Placebo Comparator: 2<br>Balanced Salt Solution (BSS) | Drug: Vehicle<br>* Maximum of 13 bags of BSS irrigation over a maximum of 2 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The overall incidence of adverse events regardless of relationship to study drug. |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures of safety and tolerability (e.g., clinical laboratory tests, physical examinations, etc.). |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee, Musculoskeletal System, Ligament, ACL reconstruction