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NCT00745290 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of SKY0402 in Subjects Undergoing Total Knee Arthroplasty
A Phase 3 study of Postoperative Pain, sponsored by Pacira Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 245
- Enrollment target
- 19
- Study locations
NCT00745290: Completed Phase 3 study of Postoperative Pain, sponsored by Pacira Pharmaceuticals.
NCT00745290 is a Phase 3 study of Postoperative Pain that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 245 participants, roughly in line with the 230-participant average among 120 other Postoperative Pain trials with a reported enrollment target. The trial reports 19 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00745290, a Phase 3 study of Postoperative Pain, has completed, sponsored by Pacira Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 245 participants
- Enrollment target
- 19
- Study locations
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.
Primary Outcome
The subject's pain intensity was assessed with activity (NRS-A), while actively flexing the involved knee from the maximum extension point to the maximum flexion point possible. The subject responded to the following question, "On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain did you have while bending your knee?"
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 |
What the finished NCT00745290 record still lists
NCT00745290 is an interventional study that assigns participants to a tested intervention. The registered 245 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 230-participant average among 120 other Postoperative Pain trials with a reported enrollment target.
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.
NCT00745290 lists 19 locations in 11 states (California, Alabama, North Carolina).
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.
What interventions are being tested in trial NCT00745290?
The interventions under investigation include: Bupivacaine HCl (DRUG), SKY0402 (DRUG).
Who is sponsoring clinical trial NCT00745290?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Postoperative Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00745290's enrollment target sits among peer trials
245 26th of 120 higher than 95 of 120 other Postoperative Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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