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

May 1, 2009 updated by: Anesiva, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

214

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: Placebo Comparator
Direct instillation into the surgical site
Experimental: 1
4975 - 15 mg
Drug: 4975, 15 and 5 mg
Direct instillation into the surgical site
Other Names:
  • Adlea
Experimental: 3
4975 - truncated for Phase 3
Drug: 4975 - 5 mg
Direct instillation into the surgical site

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Other efficacy parameters, safety and tolerability of 4975
Time Frame: 42 Days or Early Termination
42 Days or Early Termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anesiva, Inc.

Investigators

  • Study Director: Shaun Comfort, MD, Anesiva, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

May 16, 2008

First Submitted That Met QC Criteria

May 16, 2008

First Posted (Estimate)

May 21, 2008

Study Record Updates

Last Update Posted (Estimate)

May 4, 2009

Last Update Submitted That Met QC Criteria

May 1, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 114-01P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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