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Sponsored by: |
Pacira Pharmaceuticals, Inc |
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Information provided by: | Pacira Pharmaceuticals, Inc |
ClinicalTrials.gov Identifier: | NCT00745290 |
Demonstrate that SKY0402 is superior when compared to bupivacaine HCl in the management of postoperative pain for patients undergoing total knee arthroplasty.
Condition | Intervention | Phase |
---|---|---|
Total Knee Arthroplasty Postoperative Pain |
Drug: HCl Drug: DepoBupivacaine |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Active Control Study to Evaluate the Safety and Efficacy of a Single Intraoperative Administration of SKY0402 For Prolonged Postoperative Analgesia in Subject Undergoing Total Knee Arthroplasty |
Estimated Enrollment: | 200 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | February 2009 |
Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
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Drug: HCl
200 mg bupivacaine HCl
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2
randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
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Drug: DepoBupivacaine
600 mg SKY0402 (study drug).
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The primary objective is to demonstrate the superiority of SKY0402, compared with bupivacaine HC1, with respect to the extent and duration of the analgesic effect achieved by a single intraoperative administration of the study drug via local infiltration in subjects undergoing total knee arthroplasty (TKA).
The secondary objectives are to evaluate additional efficacy parameters and characterize the safety profile of SKY0402 in comparison with bupivacaine HCl.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Use of any of the following medications within the times specified before surgery:
United States, Alabama | |
Horizon Research Group, Inc., Alabama Orthopaedic Clinic | |
Mobile, Alabama, United States, 36608 | |
Drug Research and Analysis Corporation | |
Montgomery, Alabama, United States, 36106 | |
West Alabama Research, Inc. | |
Birmingham, Alabama, United States, 35209 | |
United States, Arizona | |
Sun Health Research Institute, Core Institute | |
Sun City West, Arizona, United States, 85375 | |
United States, California | |
Cedars of Sinai Medical Center | |
Los Angeles, California, United States, 90048 | |
Accurate Clinical Trials, Inc. | |
Laguna Hills, California, United States, 92653 | |
Physicans Clinical Research Corp. | |
Laguna Hills, California, United States, 92653 | |
Scripps | |
La Jolla, California, United States, 92037 | |
United States, Georgia | |
Atlanta Knee and Sports Medicine | |
Decatur, Georgia, United States, 30033 | |
United States, Illinois | |
Rush University Medical Center | |
Chicago, Illinois, United States, 60612 | |
United States, New York | |
Insall Scott Kelly Institute | |
New York, New York, United States, 10065 | |
United States, North Carolina | |
CTMG, Inc. | |
Greenville, North Carolina, United States, 27834 | |
Duke University Medical Center | |
Raleigh-Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Ohio State University Medical Center | |
Columbus, Ohio, United States, 43210 | |
United States, Pennsylvania | |
Ilumina Clinical Associates | |
Johnstown, Pennsylvania, United States, 15904 | |
Allegheny Pain Management | |
Altoona, Pennsylvania, United States, 16602 | |
United States, Tennessee | |
Research Associates of Jackson | |
Jackson, Tennessee, United States, 38301 | |
United States, Texas | |
Memorial Hermann City Hospital | |
Houston, Texas, United States, 77024 | |
Texas Orthopedic Specialists, PA | |
Grapevine, Texas, United States, 76051 |
Responsible Party: | Pacira Pharmaceuticals, Inc. ( Joyce Davis, RN, Director of Clinical Research ) |
Study ID Numbers: | SIMPLE TKA 311 |
Study First Received: | August 29, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00745290 History of Changes |
Health Authority: | United States: Food and Drug Administration |
total knee arthroplasty pain |
Signs and Symptoms Postoperative Complications Central Nervous System Depressants Anesthetics Bupivacaine |
Pain Peripheral Nervous System Agents Anesthetics, Local Pain, Postoperative |
Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Pain Anesthetics, Local Pharmacologic Actions Signs and Symptoms Pathologic Processes |
Postoperative Complications Sensory System Agents Therapeutic Uses Bupivacaine Peripheral Nervous System Agents Central Nervous System Agents Pain, Postoperative |