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NCT03378076 · ClinicalTrials.gov registry record · Phase 2
Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With Bilateral Knee OA
A Phase 2 study, sponsored by Pacira Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT03378076: Completed Phase 2 study, sponsored by Pacira Pharmaceuticals.
NCT03378076 is a Phase 2 study that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03378076, a Phase 2 study, has completed, sponsored by Pacira Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a randomized, open-label, parallel group study to compare systemic exposure of triamcinolone acetonide following administration into both knees of either FX006 or TAcs.
Primary Outcome
Plasma drug concentrations (pg/mL) by Time Point across FX006 and TAcs treatment arms in plasma. For the PK analysis and individual concentration vs. time plots, a concentration that is BLOQ is assigned a value of zero if it occurs in a profile before the first measurable concentration. If a BLOQ value occurs after a measurable concentration in a profile and is followed by a value above the lower limit of quantification, then the BLOQ is treated as missing data. If a BLOQ value occurs at the en
Interventions
- DRUG FX006 32 mg
- DRUG TAcs 40 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-12-06 |
| Est. Completion | 2018-03-14 |
| Phase | Phase 2 |
What the finished NCT03378076 record still lists
NCT03378076 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which FX006 32 mg is the first listed.
NCT03378076 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03378076 about?
NCT03378076 is a clinical study titled "Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With Bilateral Knee OA". This is a randomized, open-label, parallel group study to compare systemic exposure of triamcinolone acetonide following administration into both knees of either FX006 or TAcs.
What is the current status of trial NCT03378076?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2017-12-06. Estimated completion is 2018-03-14.
What interventions are being tested in trial NCT03378076?
The interventions under investigation include: FX006 32 mg (DRUG), TAcs 40 mg (DRUG).
Who is sponsoring clinical trial NCT03378076?
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 NCT03378076's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 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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