Efficacy and Safety of OMS103HP in Patients Undergoing Allograft Anterior Cruciate Ligament (ACL) Reconstruction
NCT ID: NCT00226759
Last Updated: 2012-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
321 participants
INTERVENTIONAL
2004-11-30
2011-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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OMS103HP irrigation solution
Drug
OMS103HP
Maximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours.
vehicle irrigation solution
Vehicle
Vehicle
Maximum of 39 liters of vehicle irrigation solution over a maximum of 2 hours
Interventions
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OMS103HP
Maximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours.
Vehicle
Maximum of 39 liters of vehicle irrigation solution over a maximum of 2 hours
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
15 Years
65 Years
ALL
No
Sponsors
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Omeros Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Scott Houston
Role: STUDY_DIRECTOR
Omeros Corporation
Locations
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CORE Orthopaedic Medical Center
Encinitas, California, United States
Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.)
Redwood City, California, United States
Stanford University
Stanford, California, United States
Colorado Orthopedic Consultants, PC
Englewood, Colorado, United States
American Clinical Research Services
Steamboat Springs, Colorado, United States
University of Florida
Gainesville, Florida, United States
Southeastern Center for Clinical Trials
Atlanta, Georgia, United States
Minnesota Sports Medicine
Minneapolis, Minnesota, United States
Ohio State University
Columbus, Ohio, United States
University Orthopedics Center
Altoona, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University Orthopedics Center
State College, Pennsylvania, United States
Texas Orthopedics
Austin, Texas, United States
Round Rock Orthopedics
Round Rock, Texas, United States
Unlimited Research
San Antonio, Texas, United States
Hill Country Sports Medicine
San Marcos, Texas, United States
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States
Madigan Army Medical Center
Tacoma, Washington, United States
Rouge Valley Health Systems
Ajax, Ontario, Canada
Hotel Dieu Grace Hospital
Windsor, Ontario, Canada
Countries
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Other Identifiers
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C03511
Identifier Type: -
Identifier Source: org_study_id