Clinical trial NCT00683267: Efficacy and Safety Study of 4975 in Patients Undergoing Total Hip Replacement
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Arthroplasty
Keywords: THA, Total hip arthroplasty, total hip replacement
Lead sponsor: Anesiva, Inc.
Sponsor class: INDUSTRY
First posted: 2008-05-23
Enrollment: 118
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: TREATMENT

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

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

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 endpoints, safety and tolerability of 4975
timeFrame: 42 Days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Arcadia
country: United States
facility: Lotus Clinical Research, Inc.
state: California
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: Oakland
country: United States
facility: Webster Orthopaedic Medical Group
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco - Mt. Zion
state: California
city: Port Orange
country: United States
facility: Coastal Medical Research, Inc.
state: Florida
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Sewickley
country: United States
facility: Sewickley Valley Hospial
state: Pennsylvania
city: Lubbock
country: United States
facility: Covenant Medical Center
state: Texas
Study officials:
affiliation: Anesiva, Inc.
name: Shaun Comfort, MD, MBA
role: STUDY_DIRECTOR
affiliation: Anesiva, Inc.
name: William Houghton, MD
role: STUDY_DIRECTOR
References: