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A Phase 3 Study to Evaluate the Safety and Efficacy of SKY0402 in Subjects Undergoing Total Knee Arthroplasty
NCT00745290 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective is to demonstrate that SKY0402 is superior when compared to bupivacaine HCl in the management of postoperative pain for patients undergoing total knee arthroplasty.
Conditions Studied
Interventions
- DRUG Bupivacaine HCl
- DRUG SKY0402
Study Locations (19)
California
- Scripps — La Jolla
- Accurate Clinical Trials, Inc. — Laguna Hills
- Physicans Clinical Research Corp. — Laguna Hills
- Cedars of Sinai Medical Center — Los Angeles
Alabama
- West Alabama Research, Inc. — Birmingham
- Horizon Research Group, Inc., Alabama Orthopaedic Clinic — Mobile
- Drug Research and Analysis Corporation — Montgomery
North Carolina
- CTMG, Inc. — Greenville
- Duke University Medical Center — Raleigh-Durham
Pennsylvania
- Allegheny Pain Management — Altoona
- Ilumina Clinical Associates — Johnstown
Texas
- Texas Orthopedic Specialists, PA — Grapevine
- Memorial Hermann City Hospital — Houston
Arizona
- Sun Health Research Institute, Core Institute — Sun City West
Georgia
- Atlanta Knee and Sports Medicine — Decatur
Illinois
- Rush University Medical Center — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2008-08 |
| Est. Completion | 2009-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00745290
The ClinicalTrials.gov registry entry for NCT00745290 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 245 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pacira Pharmaceuticals, which has 31 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Postoperative Pain appearing as the primary indexed condition, and to 2 interventions — of which Bupivacaine HCl is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00745290 reports 19 study locations spanning 11 distinct geographic areas — top geographies include California, Alabama, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00745290 about?
NCT00745290 is a clinical study titled "A Phase 3 Study to Evaluate the Safety and Efficacy of SKY0402 in Subjects Undergoing Total Knee Arthroplasty". The primary objective is to demonstrate that SKY0402 is superior when compared to bupivacaine HCl in the management of postoperative pain for patients undergoing total knee arthroplasty.
What is the current status of trial NCT00745290?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 245 participants. The study started on 2008-08. Estimated completion is 2009-02.
What conditions does trial NCT00745290 study?
This clinical trial studies the following conditions: Postoperative Pain. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00745290?
The interventions under investigation include: Bupivacaine HCl (DRUG), SKY0402 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00745290?
This trial is sponsored by Pacira Pharmaceuticals, which has 31 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00745290 being conducted?
This trial has 19 study locations across Alabama, Arizona, California, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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