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NCT03046446 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Safety of Repeat Administration of FX006 Administered to Patients With Osteoarthritis of the Knee
A Phase 3 study of Osteoarthritis of the Knee, sponsored by Pacira Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 208
- Enrollment target
- 17
- Study locations
NCT03046446: Completed Phase 3 study of Osteoarthritis of the Knee, sponsored by Pacira Pharmaceuticals.
NCT03046446 is a Phase 3 study of Osteoarthritis of the Knee that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 208 participants, roughly in line with the 200-participant average among 16 other Osteoarthritis of the Knee trials with a reported enrollment target. The trial reports 17 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03046446, a Phase 3 study of Osteoarthritis of the Knee, has completed, sponsored by Pacira Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 208 participants
- Enrollment target
- 17
- Study locations
Study Summary
This is an Open-label Study to Assess the Safety of Repeat Dose of FX006 Administered to Patients with Osteoarthritis (OA) of the Knee
Primary Outcome
Analyses of adverse events (AE) were performed for events considered treatment-emergent (TE) in patients who received two doses of 32 mg FX006. TE was defined as any AE with onset after administration of the 1st dose of study drug or any event present at baseline but worsened in intensity through the study. Severity was graded by the PI using the Common Terminology Criteria for AEs Version 4.0. Grading went from Grade 1 (Mild) to Grade 5 (Death Related to AE).
Conditions Studied
Interventions
- DRUG FX006 32 mg
Study Locations (17)
California
- Dream Team Clinical Research - Anaheim
- Hope Clinical Research - Canoga Park
- Cedars-Sinai Medical Center - Los Angeles
- Artemis Institute for Clinical Research - San Diego
- Harbor-UCLA Medical Center - Torrance
Florida
- Tampa Bay Medical Research - Clearwater
- The Andrews Institute - Gulf Breeze
Massachusetts
- Brigham and Women's Hospital - Chestnut Hill
- New England Baptist Hospital - Dedham
South Carolina
- Medical University of South Carolina - Charleston
- Coastal Carolina Research Center - Mt. Pleasant
Arizona
- Tucson Orthopedic - Tucson
Louisiana
- Ochsner Sports Medicine Institute - New Orleans
New York
- Rochester Clinical Research - Rochester
North Carolina
- Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2017-02-20 |
| Est. Completion | 2018-07-19 |
| Phase | Phase 3 |
What the finished NCT03046446 record still lists
NCT03046446 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 200-participant average among 16 other Osteoarthritis of the Knee trials with a reported enrollment target.
The record links to 1 condition, with Osteoarthritis of the Knee appearing as the primary indexed condition, and to 1 intervention - of which FX006 32 mg is the first listed.
NCT03046446 lists 17 locations in 10 states (California, Florida, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT03046446 about?
NCT03046446 is a clinical study titled "Study to Assess the Safety of Repeat Administration of FX006 Administered to Patients With Osteoarthritis of the Knee". This is an Open-label Study to Assess the Safety of Repeat Dose of FX006 Administered to Patients with Osteoarthritis (OA) of the Knee
What is the current status of trial NCT03046446?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 208 participants. The study started on 2017-02-20. Estimated completion is 2018-07-19.
What conditions does trial NCT03046446 study?
This clinical trial studies the following conditions: Osteoarthritis of the Knee.
What interventions are being tested in trial NCT03046446?
The interventions under investigation include: FX006 32 mg (DRUG).
Who is sponsoring clinical trial NCT03046446?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03046446 being conducted?
This trial has 17 study locations across Arizona, California, Florida, Louisiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteoarthritis of the Knee
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 NCT03046446's enrollment target sits among peer trials
208 7th of 16 higher than 10 of 16 other Osteoarthritis of the Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis of the Knee 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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