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NCT02116972 · ClinicalTrials.gov registry record · Phase 2
Study of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee
A Phase 2 study of Osteoarthritis of the Knee, sponsored by Pacira Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 310
- Enrollment target
- 20
- Study locations
NCT02116972: Completed Phase 2 study of Osteoarthritis of the Knee, sponsored by Pacira Pharmaceuticals.
NCT02116972 is a Phase 2 study of Osteoarthritis of the Knee that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 310 participants, above the 193-participant average among 16 other Osteoarthritis of the Knee trials with a reported enrollment target (61% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02116972, a Phase 2 study of Osteoarthritis of the Knee, has completed, sponsored by Pacira Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 310 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain"and 10 indicates "pain as bad as you can imagine."
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 |
What the finished NCT02116972 record still lists
NCT02116972 is an interventional study that assigns participants to a tested intervention. The registered 310 participants enrollment target is mid-sized for trials with a published cap, above the 193-participant average among 16 other Osteoarthritis of the Knee trials with a reported enrollment target (61% higher).
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.
NCT02116972 names 20 study sites across 8 states, led by California, Florida, Alabama.
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.
What interventions are being tested in trial NCT02116972?
The interventions under investigation include: Placebo (DRUG), FX006 32 mg (DRUG), FX006 16 mg (DRUG).
Who is sponsoring clinical trial NCT02116972?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
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.
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 NCT02116972's enrollment target sits among peer trials
310 4th of 16 higher than 13 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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