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

Study Overview
=================
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

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

Conditions
-----------------
Arthroplasty

Intervention / Treatment
-----------------
* Drug: 4975, highly purified capsaicin
* Drug: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Study treatment, 4975, is instilled directly into surgical site | Drug: 4975, highly purified capsaicin<br>* One dose administered by direct instillation into the surgical site<br>* Other names: 4975, Adlea;|
| Placebo Comparator: 2<br>Placebo is instilled directly into surgical site | Drug: Placebo<br>* One dose administered by direct instillation into the surgical site<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale (NRS) measures of pain at prespecified times |  | Primary endpoint is 2 days (4-48 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other efficacy endpoints, safety and tolerability of 4975 |  | 42 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
THA, Total hip arthroplasty, total hip replacement