Evaluate the efficacy, safety and tolerability of a single intraoperative dose of 4975 in patients undergoing total hip replacement
The purpose of this study is to evaluate the efficacy, safety, and tolerability of a single intraoperative dose of 4975 in patients undergoing primary unilateral total hip arthroplasty
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
118
One dose administered by direct instillation into the surgical site
One dose administered by direct instillation into the surgical site
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
Lotus Clinical Research, Inc.
Arcadia, California, United States
Glendale Adventist Medical Center
Glendale, California, United States
Numerical Rating Scale (NRS) measures of pain at prespecified times
Time frame: Primary endpoint is 2 days (4-48 hours)
Other efficacy endpoints, safety and tolerability of 4975
Time frame: 42 Days
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Webster Orthopaedic Medical Group
Oakland, California, United States
University of California at San Francisco - Mt. Zion
San Francisco, California, United States
Coastal Medical Research, Inc.
Port Orange, Florida, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
William Beaumont Hospital
Troy, Michigan, United States
Sewickley Valley Hospial
Sewickley, Pennsylvania, United States
Covenant Medical Center
Lubbock, Texas, United States