Efficacy and Safety Study of 4975 in Patients Undergoing Total Hip 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: NCT00683267
Recruitment Status : Terminated (Enrollment of patients has halted prematurely and will not resume. No future patients will be enrolled or treated.)
First Posted : May 23, 2008
Last Update Posted : May 4, 2009
Information provided by:
Anesiva, Inc.

Brief Summary:
Evaluate the efficacy, safety and tolerability of a single intraoperative dose of 4975 in patients undergoing total hip replacement

Condition or disease Intervention/treatment Phase
Arthroplasty Drug: 4975, highly purified capsaicin Drug: Placebo Phase 2

Detailed Description:
The purpose of this study is to evaluate the efficacy, safety, and tolerability of a single intraoperative dose of 4975 in patients undergoing primary unilateral total hip arthroplasty

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of a Single Intraoperative Localized Instillation of 4975 in Patients Undergoing Primary Unilateral Total Hip Arthroplasty
Study Start Date : September 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement
Drug Information available for: Capsaicin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Study treatment, 4975, is instilled directly into surgical site
Drug: 4975, highly purified capsaicin
One dose administered by direct instillation into the surgical site
Other Name: 4975, Adlea
Placebo Comparator: 2
Placebo is instilled directly into surgical site
Drug: Placebo
One dose administered by 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 endpoints, safety and tolerability of 4975 [ Time Frame: 42 Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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, III
  • Planning to undergo unilateral THA
  • In good health and capable of undergoing THA with spinal block and sedation anesthesia
  • No additional planned surgeries during the course of the trial
  • Willing and able to complete the study procedures and pain scales and to communicate meaningfully in English

Key Exclusion Criteria:

  • A body mass index greater than 40
  • Known bleeding disorder or is taking agents affecting coagulation preoperatively
  • A medical condition that could adversely impact the patient's participation, safety, or conduct of the study
  • Diabetes mellitus with a known HbA1C>9.5 or a history of prolonged uncontrolled diabetes
  • Previous hip arthroplasty of the same hip
  • Participated in another clinical trial within 30 days of the planned hip 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): NCT00683267

United States, Alabama
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35235
United States, California
Lotus Clinical Research, Inc.
Arcadia, California, United States, 91007
Glendale Adventist Medical Center
Glendale, California, United States, 91206
Webster Orthopaedic Medical Group
Oakland, California, United States, 94612
University of California at San Francisco - Mt. Zion
San Francisco, California, United States, 94115
United States, Florida
Coastal Medical Research, Inc.
Port Orange, Florida, United States, 32127
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
William Beaumont Hospital
Troy, Michigan, United States, 48085
United States, Pennsylvania
Sewickley Valley Hospial
Sewickley, Pennsylvania, United States, 15143
United States, Texas
Covenant Medical Center
Lubbock, Texas, United States, 79410
Sponsors and Collaborators
Anesiva, Inc.
Study Director: Shaun Comfort, MD, MBA Anesiva, Inc.
Study Director: William Houghton, MD Anesiva, Inc.

Additional Information:
Responsible Party: Shaun Comfort, MD, Anesiva, Inc. Identifier: NCT00683267     History of Changes
Other Study ID Numbers: 114-03P
First Posted: May 23, 2008    Key Record Dates
Last Update Posted: May 4, 2009
Last Verified: May 2009

Keywords provided by Anesiva, Inc.:
THA, Total hip arthroplasty, total hip replacement

Additional relevant MeSH terms:
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs