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

Anesiva, Inc.214 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

214

Conditions

Total Knee Arthroplasty (Replacement)

Interventions

4975, 15 and 5 mgDRUG

Direct instillation into the surgical site

Placebo ComparatorDRUG

Direct instillation into the surgical site

4975 - 5 mgDRUG

Direct instillation into the surgical site

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (25)

Outcomes

Primary Outcomes

Numerical Rating Scale (NRS) measures of pain at prespecified times

Time frame: Primary endpoint is 2 days (4-48 hours)

Secondary Outcomes

Other efficacy parameters, safety and tolerability of 4975

Time frame: 42 Days or Early Termination

Data from ClinicalTrials.gov

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