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

Anesiva

Status and phase

Terminated

Phase 2

Conditions

Arthroplasty

Treatments

Drug: Placebo

Drug: 4975, highly purified capsaicin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00683267

114-03P

Details and patient eligibility

About

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

Full 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

Enrollment

118 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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