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

This study has been completed.
Sponsor:
Information provided by:
Anesiva, Inc.
ClinicalTrials.gov Identifier:
NCT00681356
First received: May 16, 2008
Last updated: May 1, 2009
Last verified: May 2009
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Anesiva, Inc.:

Primary Outcome Measures:
  • Numerical Rating Scale (NRS) measures of pain at prespecified times [ Time Frame: Primary endpoint is 2 days (4-48 hours) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Other efficacy parameters, safety and tolerability of 4975 [ Time Frame: 42 Days or Early Termination ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 214
Study Start Date: September 2007
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
4975 - 15 mg
Drug: 4975, 15 and 5 mg
Direct instillation into the surgical site
Other Name: Adlea
Placebo Comparator: 2
Placebo
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681356

Locations
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
Saddleback Memorial Medical Center/Accurate Clinical Trials
Laguna Hills, California, United States, 92653
Physicians Clinical Research Corporation
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
Miami Institute for Medical Research
Miami, Florida, United States, 33186
University of Miami, Miller School of Medicine
Miami, Florida, United States, 33136
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.
Investigators
Study Director: Shaun Comfort, MD Anesiva, Inc.
  More Information

No publications provided by Anesiva, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lisa Renick, CRA, Anesiva, Inc,
ClinicalTrials.gov Identifier: NCT00681356     History of Changes
Other Study ID Numbers: 114-01P
Study First Received: May 16, 2008
Last Updated: May 1, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 21, 2014