Safety and Efficacy Study of 4975 in Patients Undergoing Total Knee Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00681356
Recruitment Status : Completed
First Posted : May 21, 2008
Last Update Posted : May 4, 2009
Information provided by:
Anesiva, Inc.

Brief Summary:
Evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing total knee replacement

Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty (Replacement) Drug: 4975, 15 and 5 mg Drug: Placebo Comparator Drug: 4975 - 5 mg Phase 3

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : September 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: 1
4975 - 15 mg
Drug: 4975, 15 and 5 mg
Direct instillation into the surgical site
Other Name: Adlea

Placebo Comparator: 2
Drug: Placebo Comparator
Direct instillation into the surgical site

Experimental: 3
4975 - truncated for Phase 3
Drug: 4975 - 5 mg
Direct instillation into the surgical site

Primary Outcome Measures :
  1. Numerical Rating Scale (NRS) measures of pain at prespecified times [ Time Frame: Primary endpoint is 2 days (4-48 hours) ]

Secondary Outcome Measures :
  1. Other efficacy parameters, safety and tolerability of 4975 [ Time Frame: 42 Days or Early Termination ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00681356

United States, Alabama
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35235
Springhill Medical Center
Mobile, Alabama, United States, 36608
Hellen Keller Hospital
Sheffield, Alabama, United States, 35660
United States, Arizona
Visions Clinical Research/Tucson Medical Center
Tucson, Arizona, United States, 85712
United States, California
Glendale Adventist Medical Center - Lotus Clinical Research
Glendale, California, United States, 91206
Physicians Clinical Research Corporation
Laguna Hills, California, United States, 92653
Saddleback Memorial Medical Center/Accurate Clinical Trials
Laguna Hills, California, United States, 92653
Webster Orthopeadic Medical Group
Oakland, California, United States, 94612
UCSF-Mt. Zion Medical Center
San Francisco, California, United States, 94115
United States, Connecticut
Orthopedic Associates of Hartford
Hartford, Connecticut, United States, 06106
United States, Florida
Florida Hospital - Florida Research Associates, LLC
DeLand, Florida, United States, 32720
University of Miami, Miller School of Medicine
Miami, Florida, United States, 33136
Miami Institute for Medical Research
Miami, Florida, United States, 33186
Southeastern Clinical Research Consultants
Orlando, Florida, United States, 32804
Coastal Medical Research
Port Orange, Florida, United States, 32127
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Maryland
Ruxton Professional Center - Orthopaedic Associates
Towson, Maryland, United States, 21204
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48085
William Beaumont Hospital
Troy, Michigan, United States, 48085
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Sewickley Valley Hospital
Sewickley, Pennsylvania, United States, 15143
United States, Texas
Presbyterian Hospital of Dallas
Dallas, Texas, United States, 75231
Memorial City Hospital - Memorial Hermann Healthcare System
Houston, Texas, United States, 77024
Sponsors and Collaborators
Anesiva, Inc.
Study Director: Shaun Comfort, MD Anesiva, Inc.

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Lisa Renick, CRA, Anesiva, Inc, Identifier: NCT00681356     History of Changes
Other Study ID Numbers: 114-01P
First Posted: May 21, 2008    Key Record Dates
Last Update Posted: May 4, 2009
Last Verified: May 2009

Keywords provided by Anesiva, Inc.:
Total knee arthroplasty
Total knee replacement
Knee surgery