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

Study Overview
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Brief Summary
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Evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing total knee replacement

Detailed Description
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The purpose of this study is to evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing primary unilateral total knee arthroplasty

Official Title
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A Phase 3, Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, Safety, and Pharmacokinetics of 4975 in Patients Undergoing Primary Unilateral Total Knee Arthroplasty

Conditions
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Total Knee Arthroplasty (Replacement)

Intervention / Treatment
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* Drug: 4975, 15 and 5 mg
* Drug: Placebo Comparator
* Drug: 4975 - 5 mg


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Male or female aged 18 to 85 years with an American Society of Anesthesiologists (ASA) status of I, II, or III Planning to undergo primary unilateral Total Knee Arthroplasty (TKA) Key Exclusion Criteria: A body mass index (BMI) greater than 43 Known bleeding disorder or is taking agents affecting coagulation preoperatively Use of medications or a medical condition that in the investigator's opinion could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments Diabetes mellitus with a known HbA1C>9.5 or a history of prolonged uncontrolled diabetes Previous knee arthroplasty (partial or total) of the same knee Participated in another clinical trial within 30 days prior to the planned TKA surgery

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>4975 - 15 mg | Drug: 4975, 15 and 5 mg<br>* Direct instillation into the surgical site<br>* Other names: Adlea;|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo Comparator<br>* Direct instillation into the surgical site<br>|
| Experimental: 3<br>4975 - truncated for Phase 3 | Drug: 4975 - 5 mg<br>* Direct instillation into the surgical site<br>|

What is the study measuring?
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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 parameters, safety and tolerability of 4975 |  | 42 Days or Early Termination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TKA, Total knee arthroplasty, Total knee replacement, Knee surgery