Status:
COMPLETED
Safety and Efficacy Study of 4975 in Patients Undergoing Total Knee Replacement
Lead Sponsor:
Anesiva, Inc.
Conditions:
Total Knee Arthroplasty (Replacement)
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
Evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing total knee replacement
Detailed Description
The purpose of this study is to evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing primary unilateral total knee arthroplasty
Eligibility Criteria
Inclusion
- Key
- Male or female aged 18 to 85 years with an American Society of Anesthesiologists (ASA) status of I, II, or III
- Planning to undergo primary unilateral Total Knee Arthroplasty (TKA)
- Key
Exclusion
- A body mass index (BMI) greater than 43
- Known bleeding disorder or is taking agents affecting coagulation preoperatively
- Use of medications or a medical condition that in the investigator's opinion could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments
- Diabetes mellitus with a known HbA1C\>9.5 or a history of prolonged uncontrolled diabetes
- Previous knee arthroplasty (partial or total) of the same knee
- Participated in another clinical trial within 30 days prior to the planned TKA surgery
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT00681356
Start Date
September 1 2007
End Date
December 1 2008
Last Update
May 4 2009
Active Locations (25)
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1
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35235
2
Springhill Medical Center
Mobile, Alabama, United States, 36608
3
Hellen Keller Hospital
Sheffield, Alabama, United States, 35660
4
Visions Clinical Research/Tucson Medical Center
Tucson, Arizona, United States, 85712