A Phase 3 Study to Evaluate the Safety and Efficacy of SKY0402 in Subjects Undergoing Total Knee Arthroplasty
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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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00745290
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 245 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2008 (Type not available)
- Primary completion
- Jan 2009 (Actual)
- Completion
- Feb 2009 (Actual)
- Last update posted
- Aug 6, 2013
2008 – 2009
United States locations
- U.S. sites
- 19
- U.S. states
- 11
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| West Alabama Research, Inc. | Birmingham | Alabama | 35209 | — |
| Horizon Research Group, Inc., Alabama Orthopaedic Clinic | Mobile | Alabama | 36608 | — |
| Drug Research and Analysis Corporation | Montgomery | Alabama | 36106 | — |
| Sun Health Research Institute, Core Institute | Sun City West | Arizona | 85375 | — |
| Scripps | La Jolla | California | 92037 | — |
| Accurate Clinical Trials, Inc. | Laguna Hills | California | 92653 | — |
| Physicans Clinical Research Corp. | Laguna Hills | California | 92653 | — |
| Cedars of Sinai Medical Center | Los Angeles | California | 90048 | — |
| Atlanta Knee and Sports Medicine | Decatur | Georgia | 30033 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Insall Scott Kelly Institute | New York | New York | 10065 | — |
| CTMG, Inc. | Greenville | North Carolina | 27834 | — |
| Duke University Medical Center | Raleigh-Durham | North Carolina | 27710 | — |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | — |
| Allegheny Pain Management | Altoona | Pennsylvania | 16602 | — |
| Ilumina Clinical Associates | Johnstown | Pennsylvania | 15904 | — |
| Research Associates of Jackson | Jackson | Tennessee | 38301 | — |
| Texas Orthopedic Specialists, PA | Grapevine | Texas | 76051 | — |
| Memorial Hermann City Hospital | Houston | Texas | 77024 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00745290, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 6, 2013 · Synced Nov 14, 2026
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