Anterior Cruciate Ligament Reconstruction Clinical Trial
Official title:
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
Verified date | June 2011 |
Source | Omeros Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 480 |
Est. completion date | March 2011 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 17 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Rush University | Chicago | Illinois |
United States | Ohio State University Sports Medicine | Columbus | Ohio |
United States | Advanced Orthopedic and Sports Medicine Specialists | Denver | Colorado |
United States | Duke University | Durham | North Carolina |
United States | Colorado Orthopedic Consultants, PC | Englewood | Colorado |
United States | Kerlan-Jobe Orthopaedic Clinic | Los Angeles | California |
United States | Temple University Orthopedics | Philadelphia | Pennsylvania |
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.) | Redwood City | California |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Omeros Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The overall incidence of adverse events regardless of relationship to study drug. | 90 days | Yes | |
Secondary | Measures of safety and tolerability (e.g., clinical laboratory tests, physical examinations, etc.). | 30 days | Yes |
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