- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00226772
Efficacy and Safety of OMS103HP in Patients Undergoing Autograft Anterior Cruciate Ligament (ACL) Reconstruction
Double-Blind, Multicenter Phase 3 Study Comparing the Efficacy and Safety of OMS103HP With Vehicle in Patients Undergoing Autograft 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 using a hamstring autograft. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee range of motion, and earlier return to work.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
Alberta
-
Calgary, Alberta, Canada, T2G 5B6
- Lifemark Health Research Group
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Ontario
-
Ajax, Ontario, Canada, L1S 2J5
- Rouge Valley Health Systems
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London, Ontario, Canada, N6A 3K7
- Fowler Kennedy Sport Medicine Clinic
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-
-
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California
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Encinitas, California, United States, 92024
- CORE Orthopaedic Medical Center
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Colorado
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Denver, Colorado, United States, 80230
- Advanced Orthopedic and Sports Medicine Specialists
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Englewood, Colorado, United States, 80110
- Colorado Orthopedic Consultants, PC
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Florida
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Gainesville, Florida, United States, 32611
- University of Florida
-
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Michigan
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Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital
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-
Minnesota
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Minneapolis, Minnesota, United States, 55454
- Minnesota Sports Medicine
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-
Pennsylvania
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Altoona, Pennsylvania, United States, 16602
- University Orthopedics Center - Altoona
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State College, Pennsylvania, United States, 16801
- University Orthopedics Center
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Texas
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Austin, Texas, United States, 78759
- Texas Orthopedics
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Odessa, Texas, United States, 79761
- Basin Orthopedic Surgical Specialists
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Round Rock, Texas, United States, 78681
- Round Rock Orthopedics
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San Antonio, Texas, United States, 78217
- Unlimited Research
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San Marcos, Texas, United States, 78666
- Hill Country Sports Medicine
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Virginia
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Portsmouth, Virginia, United States, 23708
- Naval Medical Center - Portsmouth
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Washington
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Tacoma, Washington, United States, 98431
- Madigan Army Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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 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
Study Plan
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
|
Maximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours
|
Placebo Comparator: vehicle irrigation solution
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
Sponsor
Investigators
- Study Director: Scott Houston, Omeros Corporation
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C03512
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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