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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Omeros Corporation
ClinicalTrials.gov Identifier:
NCT00226772
First received: September 26, 2005
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
  Purpose

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 using a hamstring autograft. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee range of motion, and earlier return to work.


Condition Intervention Phase
Knee Injuries
 Drug: OMS103HP
Drug: Vehicle
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind, Multicenter Phase 3 Study Comparing the Efficacy and Safety of OMS103HP With Vehicle in Patients Undergoing Autograft ACL Reconstruction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Omeros Corporation:

Primary Outcome Measures:
  • Improvement in knee function [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decreased pain [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Improved range of motion [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Earlier return to work [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 326
Study Start Date: June 2005
Study Completion Date: March 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 participate in the study rehabilitation protocol
  • and other inclusion criteria

Exclusion Criteria:

  • Allergies to any of the individual ingredients in OMS103HP
  • Taking medications with the same activities as that of the active ingredients in OMS103HP for defined time intervals prior to and after surgery
  • Associated knee injuries likely to interfere with evaluation of the study drug
  • and other exclusion criteria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226772

Locations
United States, California
CORE Orthopaedic Medical Center
Encinitas, California, United States, 92024
United States, Colorado
Advanced Orthopedic and Sports Medicine Specialists
Denver, Colorado, United States, 80230
Colorado Orthopedic Consultants, PC
Englewood, Colorado, United States, 80110
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Minnesota Sports Medicine
Minneapolis, Minnesota, United States, 55454
United States, Pennsylvania
University Orthopedics Center - Altoona
Altoona, Pennsylvania, United States, 16602
University Orthopedics Center
State College, Pennsylvania, United States, 16801
United States, Texas
Texas Orthopedics
Austin, Texas, United States, 78759
Basin Orthopedic Surgical Specialists
Odessa, Texas, United States, 79761
Round Rock Orthopedics
Round Rock, Texas, United States, 78681
Unlimited Research
San Antonio, Texas, United States, 78217
Hill Country Sports Medicine
San Marcos, Texas, United States, 78666
United States, Virginia
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States, 23708
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
Canada, Alberta
Lifemark Health Research Group
Calgary, Alberta, Canada, T2G 5B6
Canada, Ontario
Rouge Valley Health Systems
Ajax, Ontario, Canada, L1S 2J5
Fowler Kennedy Sport Medicine Clinic
London, Ontario, Canada, N6A 3K7
Sponsors and Collaborators
Omeros Corporation
Investigators
Study Director: Scott Houston Omeros Corporation
  More Information

No publications provided

Responsible Party: Omeros Corporation
ClinicalTrials.gov Identifier: NCT00226772     History of Changes
Other Study ID Numbers: C03512
Study First Received: September 26, 2005
Last Updated: October 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Omeros Corporation:
Anterior cruciate ligament reconstruction
ACL reconstruction

Additional relevant MeSH terms:
Knee Injuries
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 19, 2013