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NCT02637323 · ClinicalTrials.gov registry record · Phase 2
Study to Characterize the PK and Local Extent and Duration of Exposure From FX006 in Patients With OA of the Knee
A Phase 2 study, sponsored by Pacira Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
NCT02637323: Completed Phase 2 study, sponsored by Pacira Pharmaceuticals.
NCT02637323 is a Phase 2 study that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 81 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02637323, a Phase 2 study, has completed, sponsored by Pacira Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
Study Summary
The objectives of this study were to characterize the local extent and duration of exposure of TA from FX006 and TCA IR, characterize the systemic PK of FX006 and TCA IR, and assess the safety and general tolerability of a single 5 mL IA injection of 32 mg FX006 relative to 40 mg of TCA IR in patients with OA of the knee.
Primary Outcome
All baseline (pre-treatment) values and all post-baseline values recorded as below LLOQ (\<50 pg/mL) were set to zero. Geometric mean summary statistics were computed on adjusted concentration values. One (1) was added to each concentration value observed. BLQ values for the computation of geometric mean are included in the summary with a value of 1 (0+1).
Interventions
- DRUG FX006 32 mg
- DRUG TCA IR 40
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2015-11 |
| Est. Completion | 2016-09 |
| Phase | Phase 2 |
What the finished NCT02637323 record still lists
NCT02637323 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower).
The record links to 0 conditions, and to 2 interventions - of which FX006 32 mg is the first listed.
NCT02637323 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02637323 about?
NCT02637323 is a clinical study titled "Study to Characterize the PK and Local Extent and Duration of Exposure From FX006 in Patients With OA of the Knee". The objectives of this study were to characterize the local extent and duration of exposure of TA from FX006 and TCA IR, characterize the systemic PK of FX006 and TCA IR, and assess the safety and general tolerability of a single 5 mL IA injection of 32 mg FX006 relative to 40 mg of TCA IR in patien...
What is the current status of trial NCT02637323?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2015-11. Estimated completion is 2016-09.
What interventions are being tested in trial NCT02637323?
The interventions under investigation include: FX006 32 mg (DRUG), TCA IR 40 (DRUG).
Who is sponsoring clinical trial NCT02637323?
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 NCT02637323's enrollment target sits among peer trials
81 834th of 2000 higher than 1,159 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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