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NCT00681356 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of 4975 in Patients Undergoing Total Knee Replacement
A Phase 3 study of Total Knee Arthroplasty (Replacement), sponsored by Anesiva.
- Completed
- Registry status
- Phase 3
- Development phase
- 214
- Enrollment target
- 20
- Study locations
NCT00681356: Completed Phase 3 study of Total Knee Arthroplasty (Replacement), sponsored by Anesiva.
NCT00681356 is a Phase 3 study of Total Knee Arthroplasty (Replacement) that has completed, run by Anesiva. The registered enrollment target is 214 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00681356, a Phase 3 study of Total Knee Arthroplasty (Replacement), has completed, sponsored by Anesiva.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 214 participants
- Enrollment target
- 20
- Study locations
Study Summary
Evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing total knee replacement
Conditions Studied
Interventions
- DRUG Placebo Comparator
- DRUG 4975, 15 and 5 mg
- DRUG 4975 - 5 mg
Study Locations (20)
California
- Glendale Adventist Medical Center - Lotus Clinical Research - Glendale
- Physicians Clinical Research Corporation - Laguna Hills
- Saddleback Memorial Medical Center/Accurate Clinical Trials - Laguna Hills
- Webster Orthopeadic Medical Group - Oakland
- UCSF-Mt. Zion Medical Center - San Francisco
Florida
- Florida Hospital - Florida Research Associates, LLC - DeLand
- University of Miami, Miller School of Medicine - Miami
- Miami Institute for Medical Research - Miami
- Southeastern Clinical Research Consultants - Orlando
- Coastal Medical Research - Port Orange
Alabama
- Alabama Clinical Therapeutics, LLC - Birmingham
- Springhill Medical Center - Mobile
- Hellen Keller Hospital - Sheffield
Michigan
- William Beaumont Hospital - Royal Oak
- William Beaumont Hospital - Troy
Arizona
- Visions Clinical Research/Tucson Medical Center - Tucson
Connecticut
- Orthopedic Associates of Hartford - Hartford
Illinois
- Rush University Medical Center - Chicago
Maryland
- Ruxton Professional Center - Orthopaedic Associates - Towson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2007-09 |
| Est. Completion | 2008-12 |
| Phase | Phase 3 |
What the finished NCT00681356 record still lists
NCT00681356 is an interventional study that assigns participants to a tested intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Total Knee Arthroplasty (Replacement) appearing as the primary indexed condition, and to 3 interventions - of which Placebo Comparator is the first listed.
NCT00681356 names 20 study sites across 9 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT00681356 about?
NCT00681356 is a clinical study titled "Safety and Efficacy Study of 4975 in Patients Undergoing Total Knee Replacement". Evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing total knee replacement
What is the current status of trial NCT00681356?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 214 participants. The study started on 2007-09. Estimated completion is 2008-12.
What conditions does trial NCT00681356 study?
This clinical trial studies the following conditions: Total Knee Arthroplasty (Replacement).
What interventions are being tested in trial NCT00681356?
The interventions under investigation include: Placebo Comparator (DRUG), 4975, 15 and 5 mg (DRUG), 4975 - 5 mg (DRUG).
Who is sponsoring clinical trial NCT00681356?
This trial is sponsored by Anesiva, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00681356 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00681356's enrollment target sits among peer trials
214 1335th of 2000 higher than 666 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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