Efficacy and Safety Study of 4975 in Patients Undergoing Total Hip Replacement
May 1, 2009 updated by: Anesiva, Inc.
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
Evaluate the efficacy, safety and tolerability of a single intraoperative dose of 4975 in patients undergoing total hip replacement
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
118
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35235
- Alabama Clinical Therapeutics, LLC
-
-
California
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Arcadia, California, United States, 91007
- Lotus Clinical Research, Inc.
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Glendale, California, United States, 91206
- Glendale Adventist Medical Center
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Oakland, California, United States, 94612
- Webster Orthopaedic Medical Group
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San Francisco, California, United States, 94115
- University of California at San Francisco - Mt. Zion
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-
Florida
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Port Orange, Florida, United States, 32127
- Coastal Medical Research, Inc.
-
-
Michigan
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Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital
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Troy, Michigan, United States, 48085
- William Beaumont Hospital
-
-
Pennsylvania
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Sewickley, Pennsylvania, United States, 15143
- Sewickley Valley Hospial
-
-
Texas
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Lubbock, Texas, United States, 79410
- Covenant Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Study treatment, 4975, is instilled directly into surgical site
|
One dose administered by direct instillation into the surgical site
Other Names:
|
|
Placebo Comparator: 2
Placebo is instilled directly into surgical site
|
One dose administered by direct instillation into the surgical site
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Numerical Rating Scale (NRS) measures of pain at prespecified times
Time Frame: Primary endpoint is 2 days (4-48 hours)
|
Primary endpoint is 2 days (4-48 hours)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Other efficacy endpoints, safety and tolerability of 4975
Time Frame: 42 Days
|
42 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Shaun Comfort, MD, MBA, Anesiva, Inc.
- Study Director: William Houghton, MD, Anesiva, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
May 21, 2008
First Submitted That Met QC Criteria
May 21, 2008
First Posted (Estimate)
May 23, 2008
Study Record Updates
Last Update Posted (Estimate)
May 4, 2009
Last Update Submitted That Met QC Criteria
May 1, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 114-03P
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.