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

June 17, 2011 updated by: Omeros Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

480

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

  • United States
    • California
      • Los Angeles, California, United States, 90045
        • Kerlan-Jobe Orthopaedic Clinic
      • Redwood City, California, United States, 94063
        • Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.)
    • Colorado
      • Denver, Colorado, United States, 80230
        • Advanced Orthopedic and Sports Medicine Specialists
      • Englewood, Colorado, United States, 80110
        • Colorado Orthopedic Consultants, PC
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Ohio
      • Columbus, Ohio, United States, 43221
        • Ohio State University Sports Medicine
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Orthopedics
      • Pittsburgh, Pennsylvania, United States, 15203
        • University of Pittsburgh 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

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

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: 1
OMS103 Irrigation Solution
Drug: OMS103HP
Maximum of 13 bags of OMS103HP irrigation solution over a maximum of 2 hours
Placebo Comparator: 2
Balanced Salt Solution (BSS)
Drug: Vehicle
Maximum of 13 bags of BSS irrigation over a maximum of 2 hours.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

October 1, 2004

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

October 26, 2005

First Submitted That Met QC Criteria

October 26, 2005

First Posted (Estimate)

October 27, 2005

Study Record Updates

Last Update Posted (Estimate)

June 27, 2011

Last Update Submitted That Met QC Criteria

June 17, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • C04516

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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