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

October 10, 2012 updated by: Omeros Corporation

Double-Blind, Multicenter Phase 3 Study Comparing the Efficacy and Safety of OMS103HP With Vehicle in Patients Undergoing Allograft ACL Reconstruction

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. OMS103HP was designed to deliver targeted therapeutic agents directly to the surgical site during the arthroscopic procedure to inhibit inflammation and pain before they can begin.

The purpose of this study is to assess the effectiveness and safety of OMS103HP in improving knee function following ACL reconstruction. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee range of motion and earlier return to work.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

321

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • Rouge Valley Health Systems
      • Windsor, Ontario, Canada, N9A 1E1
        • Hotel Dieu Grace Hospital
  • United States
    • California
      • Encinitas, California, United States, 92024
        • CORE Orthopaedic Medical Center
      • Redwood City, California, United States, 94063
        • Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.)
      • Stanford, California, United States, 94305
        • Stanford University
    • Colorado
      • Englewood, Colorado, United States, 80110
        • Colorado Orthopedic Consultants, PC
      • Steamboat Springs, Colorado, United States, 80487
        • American Clinical Research Services
    • Florida
      • Gainesville, Florida, United States, 32607
        • University of Florida
    • Georgia
      • Atlanta, Georgia, United States, 30350
        • Southeastern Center for Clinical Trials
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Minnesota Sports Medicine
    • Ohio
      • Columbus, Ohio, United States, 43221
        • Ohio State University
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • University Orthopedics Center
      • Pittsburgh, Pennsylvania, United States, 15203
        • University of Pittsburgh Medical Center
      • State College, Pennsylvania, United States, 16801
        • University Orthopedics Center
    • Texas
      • Austin, Texas, United States, 78759
        • Texas Orthopedics
      • Round Rock, Texas, United States, 78681
        • Round Rock Orthopedics
      • San Antonio, Texas, United States, 78217
        • Unlimited Research
      • San Marcos, Texas, United States, 78666
        • Hill Country Sports Medicine
    • Virginia
      • Portsmouth, Virginia, United States, 23708
        • Naval Medical Center - Portsmouth
    • Washington
      • Tacoma, Washington, United States, 98431
        • Madigan Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 an allograft (patellar tendon bone, Achilles tendon, tibialis tendon, or hamstring)
  • Able to participate in the study rehabilitation protocol
  • and other inclusion criteria

Exclusion Criteria:

  • No allergies to any of the individual ingredients in OMS103HP
  • No medications with the same activities as that of the active ingredients in OMS103HP for defined time intervals prior to and after surgery
  • No associated knee injuries likely to interfere with evaluation of the study drug
  • and other exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OMS103HP irrigation solution
Drug
Drug: OMS103HP
Maximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours.
Placebo Comparator: vehicle irrigation solution
Vehicle
Drug: Vehicle
Maximum of 39 liters of vehicle irrigation solution over a maximum of 2 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in knee function
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Decreased pain
Time Frame: 30 days
30 days
Improved range of motion
Time Frame: 30 days
30 days
Earlier return to work
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Omeros Corporation

Investigators

  • Study Director: Scott Houston, Omeros Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

September 26, 2005

First Submitted That Met QC Criteria

September 26, 2005

First Posted (Estimate)

September 27, 2005

Study Record Updates

Last Update Posted (Estimate)

October 12, 2012

Last Update Submitted That Met QC Criteria

October 10, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C03511

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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