A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Knee (NCT06884865)
A Phase 2, Two-Part, Randomized, Double-Blind, Active-Controlled Study to Assess the Safety and Tolerability of Enekinragene Inzadenovec (PCRX-201) in Subjects With Painful Osteoarthritis of the Knee
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: Flourish Research - Birmingham — Birmingham, Alabama
Age range: 45 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (40 Sites)
Showing the first 25 of 40 sites.
- Flourish Research - Birmingham — Birmingham, Alabama
- Alabama Clinical Therapeutics, LLC — Birmingham, Alabama
- OrthoArizona — Phoenix, Arizona
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix — Phoenix, Arizona
- Osteoporosis Medical Center — Beverly Hills, California
- Advanced Clinical Research Center, LLC dba TriWest Research Associates, LLC — Chula Vista, California
- Medvin Clinical Research - Covina — Covina, California
- Beach Physicians Medical Group Inc. — Huntington Beach, California
- Horizon Clinical Research — La Mesa, California
- Source Healthcare — Santa Monica, California
- Alliance Clinical West Hills (Focus Clinical Research) — West Hills, California
- Medvin Clinical Research - Whittier — Whittier, California
- Arrow Clinical Trials — Daytona Beach, Florida
- Journey Research Inc. — Oldsmar, Florida
- Discovery Health Research Center - Plantation, FL — Plantation, Florida
- Gulfcoast Research Institute — Sarasota, Florida
- Palm Beach Research Center — West Palm Beach, Florida
- Conquest Research — Winter Park, Florida
- Pinnacle Trials, Inc. — Atlanta, Georgia
- Rush Medical College - Division of Rheumatology — Chicago, Illinois
- Accurate Clinical Research, Inc. - Lake Charles — Lake Charles, Louisiana
- Best Clinical Trials, LLC — New Orleans, Louisiana
- LifeBridge Health — Baltimore, Maryland
- Michigan Orthopaedic and Spine Surgeons — Rochester Hills, Michigan
- Physicians Research Collaboration — Lincoln, Nebraska
📞 Contact the Study Coordinator
Phone: (973) 451-4019
Email: lisa.ramsay@pacira.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Osteoarthritis (OA) of the Knee
- 53-Week Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 With Mild to Severe Tibio-Femoral Osteoarthritis of the Knee — Scottsdale, Arizona
- INJECTABLE COLD ENERGY THERAPY FOR THE MANAGEMENT OF CHRONIC PAIN ASSOCIATED WITH OSTEOARTHRITIS OF THE KNEE — Larkspur, California
- Pain Perception During Intra-Articular Knee Joint Injection: What is the Effect of Needle Gauge and the Use of Ethyl Chloride? — Sacramento, California
- The GORUN Study: Gradual Onset of RUNning and Knee Joint Health in Novice Runners — Vancouver, British Columbia
- Pharmacist-physiotherapist Collaborative Management for Early Knee Osteoarthritis — Sherwood Park, Alberta
- Novel Extended-Release Bupivacaine Polymer for Sustained Pain Relief Following Total Knee Arthroplasty — Grosse Pointe Farms, Michigan
Explore by condition: All Osteoarthritis (OA) of the Knee clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.