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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: Recruiting Phase 2 study of Osteoarthritis (OA) of the Knee, sponsored by Pacira Pharmaceuticals.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

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

FieldValue
Enrollment Target 135 participants
Start Date 2025-02-26
Est. Completion 2032-03
Phase Phase 2
Pacira Pharmaceuticals

88 total trials

What NCT06884865 shows while recruiting

NCT06884865 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, below the 1,397-participant average among 8 other Osteoarthritis (OA) of the Knee trials with a reported enrollment target (90% lower).

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 lists 17 locations in 9 states (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.

Similar trials for Osteoarthritis (OA) 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 NCT06884865's enrollment target sits among peer trials

135 7th of 8 higher than 2 of 8 other Osteoarthritis (OA) of the Knee trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Osteoarthritis (OA) 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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Source: ClinicalTrials.gov NCT06884865, the US trial registry maintained by the National Library of Medicine. NCT06884865 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.