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Sponsored by: |
Omeros Corporation |
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Information provided by: | Omeros Corporation |
ClinicalTrials.gov Identifier: | NCT00226759 |
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.
Condition | Intervention | Phase |
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Knee Injuries |
Drug: OMS103HP Drug: Vehicle |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind, Multicenter Phase 3 Study Comparing the Efficacy and Safety of OMS103HP With Vehicle in Patients Undergoing Allograft ACL Reconstruction |
Estimated Enrollment: | 280 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Drug
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Drug: OMS103HP
Maximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours.
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2: Placebo Comparator
Vehicle
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Drug: Vehicle
Maximum of 39 liters bags of vehicle irrigation solution over a maximum of 2 hours
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Ages Eligible for Study: | 15 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.) | Recruiting |
Redwood City, California, United States, 94063 | |
Contact: Louise Loh 650-995-1250 | |
Principal Investigator: Michael Dillingham, MD | |
Kerlan-Jobe Orthopaedic Clinic | Recruiting |
Los Angeles, California, United States, 90045 | |
Contact: Emily vollmer 310-665-7200 | |
Principal Investigator: Neal S ElAttrache, MD | |
CORE Orthopedics | Recruiting |
Encinitas, California, United States, 92024 | |
Contact: Farouk Awad 760-943-6700 fawad@COREOrthopaedic.com | |
Principal Investigator: Michael Skyhar, MD | |
United States, Colorado | |
Colorado Orthopedic Consultants, PC | Recruiting |
Englewood, Colorado, United States, 80110 | |
Contact: Renae Jackson 303-671-2149 rjackson@cocortho.com | |
Principal Investigator: Philip A Stull, MD | |
American Clinical Research Services | Recruiting |
Steamboat Springs, Colorado, United States, 80487 | |
Contact: Anna Petri 970-879-9911 | |
Principal Investigator: Eric Verploeg, MD | |
United States, Florida | |
University of Florida | Recruiting |
Gainesville, Florida, United States, 32611 | |
Contact: Chris Koenig, MS, ATC/L koenicj@ortho.ufl.edu | |
Principal Investigator: Peter Indelicato, MD | |
United States, Georgia | |
Southeastern Center for Clinical Trials | Recruiting |
Atlanta, Georgia, United States, 30350 | |
Contact: George Rainey, MD 404-216-7099 | |
Principal Investigator: Maurice Jove, MD | |
United States, Minnesota | |
Minnesota Sports Medicine | Recruiting |
Minneapolis, Minnesota, United States, 55454 | |
Contact: Russell Giveans mgivean1@Fairview.org | |
Principal Investigator: Christopher Larson, MD | |
United States, North Carolina | |
Wake Forest University Health Sciences | Recruiting |
Winston-Salem, North Carolina, United States, 27103 | |
Contact: Martha Holden mholden@wfubmc.edu | |
Principal Investigator: Gary G Poehling, MD | |
United States, Ohio | |
Ohio State University | Recruiting |
Columbus, Ohio, United States, 43221 | |
Contact: Breanna Beck Beck.261@osu.edu | |
Principal Investigator: Christopher Kaeding, MD | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15203 | |
Contact: Matthew Bottegal 412-432-3619 bottegalmt@anes.upmc.edu | |
Principal Investigator: Christopher Harner, MD | |
University Orthopedics Center | Recruiting |
State College, Pennsylvania, United States, 16801 | |
Contact: Kate Tyson 814-231-2101 ktyson@uoc.com | |
Principal Investigator: Thomas Ellis, MD | |
University Orthopedics Center | Recruiting |
Altoona, Pennsylvania, United States, 16602 | |
Contact: Robyn Stern 814-231-2101 rstern@uoc.com | |
Principal Investigator: Christopher McClennan, DO | |
United States, Texas | |
Hill Country Sports Medicine | Recruiting |
San Marcos, Texas, United States, 78666 | |
Contact: Melissa Gattis 512-353-8661 mag@hccrsite.com | |
Principal Investigator: Gerard M Pennington, MD | |
Unlimited Research | Recruiting |
San Antonio, Texas, United States, 78217 | |
Contact: Rhonda Seward 210-447-5160 rseward@unlimitedresearchtx.com | |
Principal Investigator: David Fox, MD | |
Plano Orthopedic Sports Medicine and Spine Center | Recruiting |
Plano, Texas, United States, 75093 | |
Contact: Jennifer Heldreth 972-250-5700 | |
Principal Investigator: Alan F Barber | |
Sports Medicine Associates of San Antonio | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Lisa Rodriquez 210-343-0807 | |
Principal Investigator: David Schmidt, MD | |
Texas Orthopedics | Recruiting |
Austin, Texas, United States, 78759 | |
Contact: Melissa Gattis 512-439-1011 | |
Principal Investigator: Gerard M Pennington, MD | |
Canada, Ontario | |
Rouge Valley Health System | Recruiting |
Ajax, Ontario, Canada, L1S 2J5 | |
Contact: Patricia Dekeseredy 905.686.0882 | |
Principal Investigator: Fathi Abuzgaya, MD |
Study Director: | Paul Strauss, MD | Omeros Corporation |
Responsible Party: | Omeros Corporation ( Gregory Demopulos, MD, CEO, CMO ) |
Study ID Numbers: | C03511 |
Study First Received: | September 26, 2005 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00226759 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anterior cruciate ligament reconstruction ACL reconstruction |
Wounds and Injuries Disorders of Environmental Origin Knee Injuries Leg Injuries |
Wounds and Injuries Disorders of Environmental Origin Knee Injuries Leg Injuries |