|
|
|
|
|
|
Sponsored by: |
Pacira Pharmaceuticals, Inc |
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 |
MedlinePlus related topics: | Knee Replacement |
Drug Information available for: | Bupivacaine Bupivacaine hydrochloride |
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: | January 2009 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
|
Drug: HCl
200 mg bupivacaine HCl
|
2
randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
|
Drug: DepoBupivacaine
600 mg SKY0402 (study drug).
|
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:
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:
Contact: Joyce Davis, RN | 1-859-396-3998 | joyced@pacira.com |
Contact: Kay Warnott, RN, ACNP | 1-859-552-5973 | kayw@pacira.com |
United States, Alabama | |||||
Horizon Research Group, Inc., Alabama Orthopaedic Clinic | Recruiting | ||||
Mobile, Alabama, United States, 36608 | |||||
Contact: Liz Hess 251-410-3705 horizonresearch@bellsouth.net | |||||
Principal Investigator: Roger M Setzler, MD | |||||
Drug Research and Analysis Corporation | Not yet recruiting | ||||
Montgomery, Alabama, United States, 36106 | |||||
Contact: Wrenn McGhee, LPN 334-265-3300 wmcghee@drugresearch.com | |||||
Principal Investigator: Steven Barrington, MD | |||||
Sub-Investigator: Thomas Wells, MD | |||||
Sub-Investigator: Henry Frazer, MD | |||||
United States, California | |||||
Cedars of Sinai Medical Center | Not yet recruiting | ||||
Los Angeles, California, United States, 90048 | |||||
Contact: Jun Tang, MD 310-423-5841 jun.tang@cshs.org | |||||
Principal Investigator: Ronald H Wender, MD | |||||
United States, North Carolina | |||||
CTMG, Inc. | Recruiting | ||||
Greenville, North Carolina, United States, 27834 | |||||
Contact: Brad Wiggs 252-902-6386 bwiggs@ctmginc.com | |||||
Contact: Virginia Wetherington 252-902-6386 vwetherington@ctmginc.com | |||||
Principal Investigator: Christopher Hasty, MD | |||||
Duke University Medical Center | Not yet recruiting | ||||
Raleigh-Durham, North Carolina, United States, 27710 | |||||
Contact: Jean Guadagnino 919-668-1948 jg124@notes.duke.edu | |||||
Principal Investigator: Tong-Joo Gan, MD | |||||
United States, Ohio | |||||
Ohio State University Medical Center | Not yet recruiting | ||||
Columbus, Ohio, United States, 43210 | |||||
Contact: Bridget Bonaventura 614-293-3559 bridget.bonaventura@osumc.edu | |||||
Principal Investigator: Sergio Bergese, MD | |||||
United States, Pennsylvania | |||||
Ilumina Clinical Associates | Recruiting | ||||
Johnstown, Pennsylvania, United States, 15904 | |||||
Contact: Shahram Rahimian 814-467-4490 srahimian@Iluminaclinical.com | |||||
Principal Investigator: David Bizousky, MD | |||||
United States, Tennessee | |||||
Research Associates of Jackson | Recruiting | ||||
Jackson, Tennessee, United States, 38301 | |||||
Contact: Pam Gibbons 731-423-8200 pgibbons@researchjackson.com | |||||
Contact: Lani Holman 731-423-8200 lholman@researchjackson.com | |||||
Principal Investigator: Timothy Hutchison, MD | |||||
Sub-Investigator: Harold Antwine, MD | |||||
Sub-Investigator: Michael Cobb, MD | |||||
Sub-Investigator: Jason Hutchison, MD | |||||
Sub-Investigator: David Johnson, MD | |||||
Sub-Investigator: David Pearce, MD | |||||
Sub-Investigator: Kelly Pucek, MD | |||||
Sub-Investigator: Adam Smith, MD |
Pacira Pharmaceuticals, Inc |
Responsible Party: | Pacira Pharmaceuticals, Inc. ( Joyce Davis, RN, Director of Clinical Research ) |
Study ID Numbers: | SIMPLE TKA 311 |
First Received: | August 29, 2008 |
Last Updated: | August 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00745290 |
Health Authority: | United States: Food and Drug Administration |
|
|
|
|