NCT03542838

Study of Resiniferatoxin for Knee Pain in Moderate to Severe Osteoarthritis

Phase 1b Double-blind Study to Assess the Safety, Tolerability and Preliminary Efficacy of Intra-articular Administration of Resiniferatoxin Versus Placebo for the Treatment of Pain Due to Moderate to Severe Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Sorrento Therapeutics, Inc. · Industry
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the safety of resiniferatoxin in patients with moderate to severe knee pain due to osteoarthritis.

Detailed description

This study is to evaluate the safety of resiniferatoxin administered intra-articularly to subjects with moderate to severe knee pain due to osteoarthritis (OA). It is also to assess the preliminary efficacy of resiniferatoxin to relieve knee pain when walking.

Conditions

• Osteoarthritis, Knee
• Pain, Knee

Interventions

Type	Name	Description
DRUG	Resiniferatoxin	Resiniferatoxin is a compound purified from natural sources.
DRUG	Saline	Saline is a normal physiological solution

Timeline

• Start date: 2018-07-12
• Primary completion: 2020-04-13
• Completion: 2021-02-11
• First posted: 2018-05-31
• Last updated: 2021-04-01

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study