Safety and Efficacy Study of 4975 in Patients Undergoing Total Knee Replacement
NCT ID: NCT00681356
Last Updated: 2009-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
214 participants
INTERVENTIONAL
2007-09-30
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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1
4975 - 15 mg
4975, 15 and 5 mg
Direct instillation into the surgical site
2
Placebo
Placebo Comparator
Direct instillation into the surgical site
3
4975 - truncated for Phase 3
4975 - 5 mg
Direct instillation into the surgical site
Interventions
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4975, 15 and 5 mg
Direct instillation into the surgical site
Placebo Comparator
Direct instillation into the surgical site
4975 - 5 mg
Direct instillation into the surgical site
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planning to undergo primary unilateral Total Knee Arthroplasty (TKA)
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Anesiva, Inc.
INDUSTRY
Responsible Party
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Anesiva, Inc,
Principal Investigators
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Shaun Comfort, MD
Role: STUDY_DIRECTOR
Anesiva, Inc.
Locations
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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
Florida Hospital - Florida Research Associates, LLC
DeLand, Florida, United States
University of Miami, Miller School of Medicine
Miami, Florida, United States
Miami Institute for Medical Research
Miami, Florida, United States
Southeastern Clinical Research Consultants
Orlando, Florida, United States
Coastal Medical Research
Port Orange, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Ruxton Professional Center - Orthopaedic Associates
Towson, Maryland, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
William Beaumont Hospital
Troy, Michigan, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Sewickley Valley Hospital
Sewickley, Pennsylvania, United States
Presbyterian Hospital of Dallas
Dallas, Texas, United States
Memorial City Hospital - Memorial Hermann Healthcare System
Houston, Texas, United States
Countries
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References
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Hartrick CT, Pestano C, Carlson N, Hartrick S. Capsaicin instillation for postoperative pain following total knee arthroplasty: a preliminary report of a randomized, double-blind, parallel-group, placebo-controlled, multicentre trial. Clin Drug Investig. 2011 Dec 1;31(12):877-82. doi: 10.1007/BF03256925.
Related Links
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Anesiva, Inc. Home Page
ADLEA Product Information
Other Identifiers
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114-01P
Identifier Type: -
Identifier Source: org_study_id
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