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NCT06884865 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Knee
A Phase 2 study of Osteoarthritis (OA) of the Knee, sponsored by Pacira Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 135
- Enrollment target
- 17
- Study locations
NCT06884865 is a Phase 2 study of Osteoarthritis (OA) of the Knee that is actively recruiting participants, run by Pacira Pharmaceuticals. The registered enrollment target is 135 participants, below the 1,397-participant average among 8 other Osteoarthritis (OA) of the Knee trials with a reported enrollment target (90% lower). The trial reports 17 study locations across 9 states.
The verdict
NCT06884865, a Phase 2 study of Osteoarthritis (OA) of the Knee, is actively recruiting participants, sponsored by Pacira Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 135 participants
- Enrollment target
- 17
- Study locations
Study Summary
The goal of this clinical trial is to learn if a single knee injection of different doses (Dose A and Dose B) of an investigation product PCRX-201, following steroid pretreatment, is safe and tolerable in male of female patients 45 to 80 years old with osteoarthritis of the knee. It will also learn how the body reacts to the PCRX-201 injection and how effective the treatment is. Researchers will compare Dose A and Dose B of PCRX-201 versus placebo from Week 1 through Week 52 to assess adverse events. Researchers will also explore how PCRX-201 may impact knee pain and joint function over time. Participants will be asked to * Visit the clinic for pretreatment and drug administration * Visit the clinic for checkups and tests: 1. Screening through Week 52: intially weekly, bi-weekly, later monthly 2. Week 53 through Week 260 (Year 5): 8 visits throughout the period
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Enekinragene Inzadenovec (PCRX-201)
Study Locations (17)
California
- Osteoporosis Medical Center - Beverly Hills
- Beach Physicians Medical Group Inc. - Huntington Beach
- Horizon Clinical Research - La Mesa
- Alliance Clinical West Hills (Focus Clinical Research) - West Hills
Florida
- Arrow Clinical Trials - Daytona Beach
- Journey Research Inc. - Oldsmar
- Palm Beach Research Center - West Palm Beach
- Conquest Research - Winter Park
South Carolina
- Clinical Trials of South Carolina - Charleston - Charleston
- Clinical Trials of South Carolina - Columbia - Columbia
Texas
- Zenos Clinical Research - Dallas
- Epic Clinical Research - Lewisville
Idaho
- Injury Care Research, LLC - Boise
Nebraska
- Physicians Research Collaboration - Lincoln
Nevada
- Excel Clinical Research - Las Vegas
New York
- NY Scientific - Brooklyn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2025-02-26 |
| Est. Completion | 2032-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06884865
The ClinicalTrials.gov registry entry for NCT06884865 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,397-participant average among 8 other Osteoarthritis (OA) of the Knee trials with a reported enrollment target (90% 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 (OA) of the Knee appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06884865 reports 17 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, South Carolina.
Frequently Asked Questions
What is clinical trial NCT06884865 about?
NCT06884865 is a clinical study titled "A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Knee". The goal of this clinical trial is to learn if a single knee injection of different doses (Dose A and Dose B) of an investigation product PCRX-201, following steroid pretreatment, is safe and tolerable in male of female patients 45 to 80 years old with osteoarthritis of the knee. It will also learn ...
What is the current status of trial NCT06884865?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 135 participants. The study started on 2025-02-26. Estimated completion is 2032-03.
What conditions does trial NCT06884865 study?
This clinical trial studies the following conditions: Osteoarthritis (OA) of the Knee.
What interventions are being tested in trial NCT06884865?
The interventions under investigation include: Placebo (BIOLOGICAL), Enekinragene Inzadenovec (PCRX-201) (BIOLOGICAL).
Who is sponsoring clinical trial NCT06884865?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06884865 being conducted?
This trial has 17 study locations across California, Florida, Idaho, Nebraska, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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