NCT04885972

Study to Evaluate Intra-articular Resiniferatoxin to Treat Moderate to Severe Pain From Knee Osteoarthritis

A Phase 2, Randomized, Active and Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of Intra-articular Resiniferatoxin to Treat Moderate to Severe Pain From Knee Osteoarthritis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Sorrento Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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..

Detailed description

This study is a multi-center, Phase 2, randomized, dose ranging, assessor-blinded, active and placebo-controlled, parallel-group prospective study evaluating 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. A planned 112 subjects will be randomized to one of 7 groups (n=16 each) with each subject receiving one IA injection in the index knee joint (the knee primarily affected by pain if bilateral).

Conditions

• Osteoarthritis, Knee
• Knee Osteoarthritis
• Knee Pain Chronic

Interventions

Type	Name	Description
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	Placebo	Vehicle solution

Timeline

• Start date: 2021-11-15
• Primary completion: 2023-09-01
• Completion: 2023-11-01
• First posted: 2021-05-13
• Last updated: 2023-01-17

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study