Safety and Efficacy Study of 4975 in Patients Undergoing Total Knee Replacement
A Phase 3, Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, Safety, and Pharmacokinetics of 4975 in Patients Undergoing Primary Unilateral Total Knee Arthroplasty
1 other identifier
interventional
214
1 country
25
Brief Summary
Evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing total knee replacement
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2007
Shorter than P25 for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 16, 2008
CompletedFirst Posted
Study publicly available on registry
May 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedMay 4, 2009
May 1, 2009
1 year
May 16, 2008
May 1, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Numerical Rating Scale (NRS) measures of pain at prespecified times
Primary endpoint is 2 days (4-48 hours)
Secondary Outcomes (1)
Other efficacy parameters, safety and tolerability of 4975
42 Days or Early Termination
Study Arms (3)
1
EXPERIMENTAL4975 - 15 mg
2
PLACEBO COMPARATORPlacebo
3
EXPERIMENTAL4975 - truncated for Phase 3
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Anesiva, Inc.lead
Study Sites (25)
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235, United States
Springhill Medical Center
Mobile, Alabama, 36608, United States
Hellen Keller Hospital
Sheffield, Alabama, 35660, United States
Visions Clinical Research/Tucson Medical Center
Tucson, Arizona, 85712, United States
Glendale Adventist Medical Center - Lotus Clinical Research
Glendale, California, 91206, United States
Physicians Clinical Research Corporation
Laguna Hills, California, 92653, United States
Saddleback Memorial Medical Center/Accurate Clinical Trials
Laguna Hills, California, 92653, United States
Webster Orthopeadic Medical Group
Oakland, California, 94612, United States
UCSF-Mt. Zion Medical Center
San Francisco, California, 94115, United States
Orthopedic Associates of Hartford
Hartford, Connecticut, 06106, United States
Florida Hospital - Florida Research Associates, LLC
DeLand, Florida, 32720, United States
University of Miami, Miller School of Medicine
Miami, Florida, 33136, United States
Miami Institute for Medical Research
Miami, Florida, 33186, United States
Southeastern Clinical Research Consultants
Orlando, Florida, 32804, United States
Coastal Medical Research
Port Orange, Florida, 32127, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Ruxton Professional Center - Orthopaedic Associates
Towson, Maryland, 21204, United States
William Beaumont Hospital
Royal Oak, Michigan, 48085, United States
William Beaumont Hospital
Troy, Michigan, 48085, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Sewickley Valley Hospital
Sewickley, Pennsylvania, 15143, United States
Presbyterian Hospital of Dallas
Dallas, Texas, 75231, United States
Memorial City Hospital - Memorial Hermann Healthcare System
Houston, Texas, 77024, United States
Related Publications (1)
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.
PMID: 21971213DERIVED
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Shaun Comfort, MD
Anesiva, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 16, 2008
First Posted
May 21, 2008
Study Start
September 1, 2007
Primary Completion
September 1, 2008
Study Completion
December 1, 2008
Last Updated
May 4, 2009
Record last verified: 2009-05