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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2010

Detailed Description

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.

Interventions

  • Drug: OMS103HP
    • Maximum of 13 bags of OMS103HP irrigation solution over a maximum of 2 hours
  • Drug: Vehicle
    • Maximum of 13 bags of BSS irrigation over a maximum of 2 hours.

Arms, Groups and Cohorts

  • Experimental: 1
    • OMS103 Irrigation Solution
  • Placebo Comparator: 2
    • Balanced Salt Solution (BSS)

Clinical Trial Outcome Measures

Primary Measures

  • The overall incidence of adverse events regardless of relationship to study drug.
    • Time Frame: 90 days

Secondary Measures

  • Measures of safety and tolerability (e.g., clinical laboratory tests, physical examinations, etc.).
    • Time Frame: 30 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 17 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Omeros Corporation
  • Provider of Information About this Clinical Study
    • Gregory Demopulos, MD, CEO, CMO, Omeros Corporation
  • Overall Official(s)
    • Scott Houston, Study Director, Omeros Corporation

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