Status:
TERMINATED
Efficacy and Safety Study of 4975 in Patients Undergoing Total Hip Replacement
Lead Sponsor:
Anesiva, Inc.
Conditions:
Arthroplasty
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
Evaluate the efficacy, safety and tolerability of a single intraoperative dose of 4975 in patients undergoing total hip replacement
Detailed Description
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
Eligibility Criteria
Inclusion
- Key
- Male or female aged 18 to 85 years with an American Society of Anesthesiologists (ASA) status of I, II, III
- Planning to undergo unilateral THA
- In good health and capable of undergoing THA with spinal block and sedation anesthesia
- No additional planned surgeries during the course of the trial
- Willing and able to complete the study procedures and pain scales and to communicate meaningfully in English
- Key
Exclusion
- A body mass index greater than 40
- Known bleeding disorder or is taking agents affecting coagulation preoperatively
- A medical condition that could adversely impact the patient's participation, safety, or conduct of the study
- Diabetes mellitus with a known HbA1C\>9.5 or a history of prolonged uncontrolled diabetes
- Previous hip arthroplasty of the same hip
- Participated in another clinical trial within 30 days of the planned hip surgery
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00683267
Start Date
September 1 2007
End Date
December 1 2008
Last Update
May 4 2009
Active Locations (10)
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1
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35235
2
Lotus Clinical Research, Inc.
Arcadia, California, United States, 91007
3
Glendale Adventist Medical Center
Glendale, California, United States, 91206
4
Webster Orthopaedic Medical Group
Oakland, California, United States, 94612