Study to Evaluate Intra-articular Resiniferatoxin to Treat Moderate to Severe Pain From Knee Osteoarthritis
NCT04885972 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124
Last updated 2023-01-17
Summary
This study evaluates the efficacy and safety of a single IA injection of various RTX doses, Zilretta or placebo for the treatment of pain due to moderate to severe osteoarthritis knee pain..
Conditions
- Osteoarthritis, Knee
- Knee Osteoarthritis
- Knee Pain Chronic
Interventions
- DRUG
-
Resiniferatoxin
Resiniferatoxin is a compound purified from natural sources.
- DRUG
-
Zilretta
Zilretta is an extended-release corticosteroid approved to manage osteoarthritis knee pain.
- DRUG
-
Vehicle solution
Sponsors & Collaborators
-
Sorrento Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Mike Royal, MD · Sorrento Therapeutics, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-15
- Primary Completion
- 2023-09-30
- Completion
- 2023-11-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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