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NCT04119687 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety and Tolerability of FX201 in Patients with Osteoarthritis of the Knee
A Phase 1 study of Osteoarthritis, Knee, sponsored by Pacira Pharmaceuticals.
- Active
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 6
- Study locations
NCT04119687 is a Phase 1 study of Osteoarthritis, Knee that is active but no longer recruiting, run by Pacira Pharmaceuticals. The registered enrollment target is 72 participants, below the 579-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (88% lower). The trial reports 6 study locations across 5 states.
The verdict
NCT04119687, a Phase 1 study of Osteoarthritis, Knee, is active but no longer recruiting, sponsored by Pacira Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 6
- Study locations
Study Summary
This two-part study will be conducted in male and female patients, 30 - 80 years of age with painful OA of the index knee with Kellgren-Lawrence (K-L) Grade 2, 3 or 4. Part 1 - Single Ascending Dose (SAD) Phase: Up to three ascending doses of FX201 will be tested in cohorts of 5-8 patients. Each patient will only receive one injection of FX201. An independent Data Monitoring Committee (DMC) will review safety and guide the conduct of the study. Part 2 - Expansion Phase: Up to an additional 35 patients will be enrolled at each dose level reviewed by the DMC. Each patient will only receive one injection of FX201.
Conditions Studied
Interventions
- BIOLOGICAL FX201
Study Locations (6)
Pennsylvania
- University Orthopedics Center - Altoona
- Altoona Center for Clinical Research - Duncansville
Arizona
- Arizona Research Center - Phoenix
Florida
- Gulfcoast Research Institute, LLC - Sarasota
Missouri
- Center for Pharmaceutical Research - Kansas City
Texas
- Metroplex Clinical Research Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2020-03-02 |
| Est. Completion | 2026-11-28 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04119687
The ClinicalTrials.gov registry entry for NCT04119687 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 579-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (88% lower). The listed sponsor is Pacira Pharmaceuticals, which has 88 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 1 intervention - of which FX201 is the first listed.
NCT04119687 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Pennsylvania, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT04119687 about?
NCT04119687 is a clinical study titled "Study to Evaluate the Safety and Tolerability of FX201 in Patients with Osteoarthritis of the Knee". This two-part study will be conducted in male and female patients, 30 - 80 years of age with painful OA of the index knee with Kellgren-Lawrence (K-L) Grade 2, 3 or 4. Part 1 - Single Ascending Dose (SAD) Phase: Up to three ascending doses of FX201 will be tested in cohorts of 5-8 patients. Each pa...
What is the current status of trial NCT04119687?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2020-03-02. Estimated completion is 2026-11-28.
What conditions does trial NCT04119687 study?
This clinical trial studies the following conditions: Osteoarthritis, Knee.
What interventions are being tested in trial NCT04119687?
The interventions under investigation include: FX201 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04119687?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04119687 being conducted?
This trial has 6 study locations across Arizona, Florida, Missouri, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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