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

This study has been terminated.
(Enrollment of patients has halted prematurely and will not resume. No future patients will be enrolled or treated.)
Sponsor:
Information provided by:
Anesiva, Inc.
ClinicalTrials.gov Identifier:
NCT00683267
First received: May 21, 2008
Last updated: May 1, 2009
Last verified: May 2009
  Purpose

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


Condition Intervention Phase
Arthroplasty
Drug: 4975, highly purified capsaicin
Drug: Placebo
Phase 2

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

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 endpoints, safety and tolerability of 4975 [ Time Frame: 42 Days ] [ Designated as safety issue: Yes ]

Enrollment: 118
Study Start Date: September 2007
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  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, 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
  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: NCT00683267

Locations
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.
Investigators
Study Director: Shaun Comfort, MD, MBA Anesiva, Inc.
Study Director: William Houghton, MD Anesiva, Inc.
  More Information

No publications provided

Responsible Party: Shaun Comfort, MD, Anesiva, Inc.
ClinicalTrials.gov Identifier: NCT00683267     History of Changes
Other Study ID Numbers: 114-03P
Study First Received: May 21, 2008
Last Updated: May 1, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Capsaicin
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014