Safety and Efficacy Study of 4975 in Patients Undergoing Total Knee Replacement
- Conditions
- Total Knee Arthroplasty (Replacement)
- Interventions
- Drug: 4975 - 5 mgDrug: Placebo ComparatorDrug: 4975, 15 and 5 mg
- Registration Number
- NCT00681356
- Lead Sponsor
- Anesiva, Inc.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 214
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 4975 - 5 mg 4975 - truncated for Phase 3 2 Placebo Comparator Placebo 1 4975, 15 and 5 mg 4975 - 15 mg
- Primary Outcome Measures
Name Time Method Numerical Rating Scale (NRS) measures of pain at prespecified times Primary endpoint is 2 days (4-48 hours)
- Secondary Outcome Measures
Name Time Method Other efficacy parameters, safety and tolerability of 4975 42 Days or Early Termination
Trial Locations
- Locations (24)
Alabama Clinical Therapeutics, LLC
🇺🇸Birmingham, Alabama, United States
Springhill Medical Center
🇺🇸Mobile, Alabama, United States
Hellen Keller Hospital
🇺🇸Sheffield, Alabama, United States
Visions Clinical Research/Tucson Medical Center
🇺🇸Tucson, Arizona, United States
Glendale Adventist Medical Center - Lotus Clinical Research
🇺🇸Glendale, California, United States
Physicians Clinical Research Corporation
🇺🇸Laguna Hills, California, United States
Saddleback Memorial Medical Center/Accurate Clinical Trials
🇺🇸Laguna Hills, California, United States
Webster Orthopeadic Medical Group
🇺🇸Oakland, California, United States
UCSF-Mt. Zion Medical Center
🇺🇸San Francisco, California, United States
Orthopedic Associates of Hartford
🇺🇸Hartford, Connecticut, United States
Scroll for more (14 remaining)Alabama Clinical Therapeutics, LLC🇺🇸Birmingham, Alabama, United States