Clinical trial NCT00681356: Safety and Efficacy Study of 4975 in Patients Undergoing Total Knee Replacement
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Total Knee Arthroplasty (Replacement)
Keywords: TKA
Total knee arthroplasty
Total knee replacement
Knee surgery
Lead sponsor: Anesiva, Inc.
Sponsor class: INDUSTRY
First posted: 2008-05-21
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Numerical Rating Scale (NRS) measures of pain at prespecified times
timeFrame: Primary endpoint is 2 days (4-48 hours)
Secondary outcomes:
measure: Other efficacy parameters, safety and tolerability of 4975
timeFrame: 42 Days or Early Termination
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Mobile
country: United States
facility: Springhill Medical Center
state: Alabama
city: Sheffield
country: United States
facility: Hellen Keller Hospital
state: Alabama
city: Tucson
country: United States
facility: Visions Clinical Research/Tucson Medical Center
state: Arizona
city: Glendale
country: United States
facility: Glendale Adventist Medical Center - Lotus Clinical Research
state: California
city: Laguna Hills
country: United States
facility: Physicians Clinical Research Corporation
state: California
city: Laguna Hills
country: United States
facility: Saddleback Memorial Medical Center/Accurate Clinical Trials
state: California
city: Oakland
country: United States
facility: Webster Orthopeadic Medical Group
state: California
city: San Francisco
country: United States
facility: UCSF-Mt. Zion Medical Center
state: California
city: Hartford
country: United States
facility: Orthopedic Associates of Hartford
state: Connecticut
city: DeLand
country: United States
facility: Florida Hospital - Florida Research Associates, LLC
state: Florida
city: Miami
country: United States
facility: University of Miami, Miller School of Medicine
state: Florida
city: Miami
country: United States
facility: Miami Institute for Medical Research
state: Florida
city: Orlando
country: United States
facility: Southeastern Clinical Research Consultants
state: Florida
city: Port Orange
country: United States
facility: Coastal Medical Research
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Towson
country: United States
facility: Ruxton Professional Center - Orthopaedic Associates
state: Maryland
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Sewickley
country: United States
facility: Sewickley Valley Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: Presbyterian Hospital of Dallas
state: Texas
city: Houston
country: United States
facility: Memorial City Hospital - Memorial Hermann Healthcare System
state: Texas
Study officials:
affiliation: Anesiva, Inc.
name: Shaun Comfort, MD
role: STUDY_DIRECTOR
References:
citation: Hartrick CT, Pestano C, Carlson N, Hartrick S. Capsaicin instillation for postoperative pain following total knee arthroplasty: a preliminary report of a randomized, double-blind, parallel-group, placebo-controlled, multicentre trial. Clin Drug Investig. 2011 Dec 1;31(12):877-82. doi: 10.1007/BF03256925.