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Study of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee
NCT02116972 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study was to assess the magnitude and duration of pain relief of a single IA injection of 2 doses (16 and 32 mg) of FX006, an extended-release formulation of TCA, relative to normal saline (placebo control).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG FX006 32 mg
- DRUG FX006 16 mg
Study Locations (20)
California
- — Anaheim
- — Canoga Park
- — El Cajon
- — Los Angeles
- — North Hollywood
- — San Diego
Florida
- — DeLand
- — Fort Lauderdale
- — Orlando
- — Pinellas Park
- — Tampa
Alabama
- — Anniston
- — Birmingham
- — Mobile
Arizona
- — Phoenix
- — Tucson
Arkansas
- — Hot Springs
Connecticut
- — Stamford
Georgia
- — Marietta
Indiana
- — Evansville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 310 participants |
| Start Date | 2014-04 |
| Est. Completion | 2015-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02116972
The ClinicalTrials.gov registry entry for NCT02116972 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 310 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pacira Pharmaceuticals, which has 31 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Osteoarthritis of the Knee appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02116972 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02116972 about?
NCT02116972 is a clinical study titled "Study of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee". The purpose of this study was to assess the magnitude and duration of pain relief of a single IA injection of 2 doses (16 and 32 mg) of FX006, an extended-release formulation of TCA, relative to normal saline (placebo control).
What is the current status of trial NCT02116972?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 310 participants. The study started on 2014-04. Estimated completion is 2015-11.
What conditions does trial NCT02116972 study?
This clinical trial studies the following conditions: Osteoarthritis of the Knee. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02116972?
The interventions under investigation include: Placebo (DRUG), FX006 32 mg (DRUG), FX006 16 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02116972?
This trial is sponsored by Pacira Pharmaceuticals, which has 31 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02116972 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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