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NCT02003365 · ClinicalTrials.gov registry record · Phase 2
Study to Characterize the Local Duration of Exposure From FX006 in Patients With Osteoarthritis of the Knee
A Phase 2 study, sponsored by Pacira Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT02003365: Completed Phase 2 study, sponsored by Pacira Pharmaceuticals.
NCT02003365 is a Phase 2 study that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02003365, a Phase 2 study, has completed, sponsored by Pacira Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
The purpose of this study was to characterize the local duration of exposure of TCA for 2 doses of FX006 relative to 40 mg of TCA IR in patients with OA of the knee.
Primary Outcome
Analyses of synovial fluid drug concentrations were performed using the Synovial Fluid Drug Concentration Population. Values recorded as lower limit of quantification (LLOQ) (\< 50 pg/mL) were counted as half the value below limit of quantification (BLQ).
Interventions
- DRUG TCA IR 40 mg
- DRUG FX006 10 mg
- DRUG FX006 40 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2013-11 |
| Est. Completion | 2014-04 |
| Phase | Phase 2 |
What the finished NCT02003365 record still lists
NCT02003365 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 3 interventions - of which TCA IR 40 mg is the first listed.
NCT02003365 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02003365 about?
NCT02003365 is a clinical study titled "Study to Characterize the Local Duration of Exposure From FX006 in Patients With Osteoarthritis of the Knee". The purpose of this study was to characterize the local duration of exposure of TCA for 2 doses of FX006 relative to 40 mg of TCA IR in patients with OA of the knee.
What is the current status of trial NCT02003365?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2013-11. Estimated completion is 2014-04.
What interventions are being tested in trial NCT02003365?
The interventions under investigation include: TCA IR 40 mg (DRUG), FX006 10 mg (DRUG), FX006 40 mg (DRUG).
Who is sponsoring clinical trial NCT02003365?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02003365's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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