A Phase 3 Study to Evaluate the Safety and Efficacy of SKY0402 in Subjects Undergoing Total Knee Arthroplasty
NCT ID: NCT00745290
Last Updated: 2013-08-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
245 participants
INTERVENTIONAL
2008-08-31
2009-02-28
Brief Summary
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Detailed Description
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The secondary objectives are to evaluate additional efficacy parameters and characterize the safety profile of SKY0402 in comparison with bupivacaine HCl.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Bupivacaine HCl
Single dose of 200 mg bupivacaine HCl administered intraoperatively via local infiltration
Bupivacaine HCl
200 mg bupivacaine HCl
SKY0402
Single dose of 600 mg SKY0402 (study drug) administered intraoperatively via local infiltration
SKY0402
600 mg SKY0402 (study drug).
Interventions
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Bupivacaine HCl
200 mg bupivacaine HCl
SKY0402
600 mg SKY0402 (study drug).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Female subjects only: Postmenopausal, surgically sterile, or willing to use acceptable means of contraception for at least 30 days after surgery including any of the following: hormonal contraceptives (e.g., oral, injectable, implantable starting at least 30 days before study drug administration), effective double-barrier methods (e.g., condoms with spermicide), intrauterine device, lifestyle with a personal choice of abstinence, nonheterosexual lifestyle, or a strictly monogamous relationship with a partner who has had a vasectomy.
3. Scheduled to undergo primary unilateral TKA under general or spinal anesthesia.
4. American Society of Anesthesiology (ASA) Physical Classification System class 1-4.
5. Able and willing to comply with all study visits and procedures.
6. Able to speak, read, and understand the language of the informed consent form, study questionnaires, and other instruments used for collecting subject-reported outcomes, in order to enable accurate and appropriate responses to pain scales and other required study assessments.
7. Willing and capable of providing written informed consent.
Exclusion Criteria
2. Use of any of the following medications within the times specified before surgery:
* Long-acting opioid medication within 3 days.
* Any opioid medication within 24 hours.
3. Concurrent painful physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain that is not strictly related to the surgical site being administered study drug (e.g., significant pain from other joints, chronic neuropathic pain, concurrent contralateral TKA, concurrent foot surgery, etc.), which have the potential to confound the postoperative study assessments.
4. Body weight less than 60 kilograms (\~132 pounds).
5. Contraindication to any of the pain-control agents planned for postoperative use (e.g., acetaminophen, morphine, oxycodone, ketorolac).
6. Contraindication to epinephrine, such as concurrent administration of ergot-type drugs, monoamine oxidase (MAO) inhibitors or antidepressants of triptoline or imipramine types, conditions where the production or exacerbation of tachycardia could prove fatal (e.g., poorly controlled thyrotoxicosis or severe heart disease), or any other pathological conditions that might be aggravated by the effects of epinephrine.
7. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
8. Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
9. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance.
10. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may increase the risk of surgery or complicate the subject's postoperative course.
11. Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures, and expose the subject to an unreasonable risk as a result of participating in this clinical trial, such as: debilitating diseases, acute illnesses, hypotension, partial or complete conduction block, impaired cardiac function, untreated hypertension, advanced arteriosclerotic heart disease, cerebral vascular insufficiency, pre-existing abnormal neurological or neuromuscular disease (e.g., epilepsy, myasthenia gravis), advanced liver disease, severe renal impairment, advanced diabetes, comorbid conditions associated with an immunocompromised status, such as blood dyscrasias, HIV/AIDS, or recent chemotherapy.
In addition, the subject will be ineligible to receive study drug if he or she meets the following criterion during surgery:
12. Any clinically significant event or condition uncovered during surgery (e.g., excessive bleeding), which occurs before study drug administration, that might render the subject medically unstable or complicate the subject's postoperative course.
18 Years
ALL
No
Sponsors
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Pacira Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Joyce Davis, RN
Role: STUDY_DIRECTOR
Pacira Pharmaceuticals, Inc
Locations
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West Alabama Research, Inc.
Birmingham, Alabama, United States
Horizon Research Group, Inc., Alabama Orthopaedic Clinic
Mobile, Alabama, United States
Drug Research and Analysis Corporation
Montgomery, Alabama, United States
Sun Health Research Institute, Core Institute
Sun City West, Arizona, United States
Scripps
La Jolla, California, United States
Accurate Clinical Trials, Inc.
Laguna Hills, California, United States
Physicans Clinical Research Corp.
Laguna Hills, California, United States
Cedars of Sinai Medical Center
Los Angeles, California, United States
Atlanta Knee and Sports Medicine
Decatur, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Insall Scott Kelly Institute
New York, New York, United States
CTMG, Inc.
Greenville, North Carolina, United States
Duke University Medical Center
Raleigh-Durham, North Carolina, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Allegheny Pain Management
Altoona, Pennsylvania, United States
Ilumina Clinical Associates
Johnstown, Pennsylvania, United States
Research Associates of Jackson
Jackson, Tennessee, United States
Texas Orthopedic Specialists, PA
Grapevine, Texas, United States
Memorial Hermann City Hospital
Houston, Texas, United States
Countries
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References
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Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.
Other Identifiers
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SIMPLE TKA 311
Identifier Type: -
Identifier Source: org_study_id