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

Arthroplasty Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00683267
• Other study ID #: 114-03P
• Status: Terminated
• Phase: Phase 2
• First received: May 21, 2008
• Last updated: May 1, 2009
• Start date: September 2007
• Est. completion date: December 2008

Study information

• Verified date: May 2009
• Source: Anesiva, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 118
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty

Intervention

Drug:
• 4975, highly purified capsaicin
One dose administered by direct instillation into the surgical site
• Placebo
One dose administered by direct instillation into the surgical site

Locations

Country	Name	City	State
United States	Lotus Clinical Research, Inc.	Arcadia	California
United States	Alabama Clinical Therapeutics, LLC	Birmingham	Alabama
United States	Glendale Adventist Medical Center	Glendale	California
United States	Covenant Medical Center	Lubbock	Texas
United States	Webster Orthopaedic Medical Group	Oakland	California
United States	Coastal Medical Research, Inc.	Port Orange	Florida
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	University of California at San Francisco - Mt. Zion	San Francisco	California
United States	Sewickley Valley Hospial	Sewickley	Pennsylvania
United States	William Beaumont Hospital	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Anesiva, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Rating Scale (NRS) measures of pain at prespecified times		Primary endpoint is 2 days (4-48 hours)	Yes
Secondary	Other efficacy endpoints, safety and tolerability of 4975		42 Days	Yes