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

Phase 2

Terminated

• Conditions: Arthroplasty
• Interventions: Drug: Placebo; Drug: 4975, highly purified capsaicin

• Registration Number: NCT00683267
• Lead Sponsor: Anesiva, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-05-21
• Study First Submitted QC: 2008-05-21
• Study First Posted: 2008-05-23
• Primary Completion: 2008-11
• Study Completion: 2008-12
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-01
• Last Update Posted: 2009-05-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 118

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo is instilled directly into surgical site
1	4975, highly purified capsaicin	Study treatment, 4975, is instilled directly into surgical site

Primary Outcome Measures

Name	Time	Method
Numerical Rating Scale (NRS) measures of pain at prespecified times	Primary endpoint is 2 days (4-48 hours)

Secondary Outcome Measures

Name	Time	Method
Other efficacy endpoints, safety and tolerability of 4975	42 Days

Trial Locations

Locations (9)

University of California at San Francisco - Mt. Zion; 🇺🇸 San Francisco, California, United States

Webster Orthopaedic Medical Group; 🇺🇸 Oakland, California, United States

Coastal Medical Research, Inc.; 🇺🇸 Port Orange, Florida, United States

Sewickley Valley Hospial; 🇺🇸 Sewickley, Pennsylvania, United States

Alabama Clinical Therapeutics, LLC; 🇺🇸 Birmingham, Alabama, United States

Glendale Adventist Medical Center; 🇺🇸 Glendale, California, United States

Lotus Clinical Research, Inc.; 🇺🇸 Arcadia, California, United States

Covenant Medical Center; 🇺🇸 Lubbock, Texas, United States

William Beaumont Hospital; 🇺🇸 Troy, Michigan, United States