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Neurotoxin
Resiniferatoxin for Osteoarthritis
Phase 2
Waitlist Available
Research Sponsored by Sorrento Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through end of study at week 52
Summary
This trial is testing different doses of two drugs, RTX and Zilretta, to see which is best at reducing knee pain from osteoarthritis. The study involves people who have moderate to severe knee pain. The drugs are injected directly into the knee joint to help relieve pain. RTX is derived from cactus-like plants, and Zilretta is designed to provide long-lasting pain relief.
Eligible Conditions
- Osteoarthritis of the Knee
- Osteoarthritis
- Chronic Knee Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through end of study at week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through end of study at week 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Worst Average Daily Pain at Week 26
Secondary study objectives
Change in WOMAC score
Change in Worst Average Daily Pain at Week 12
Change in quality of life
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: ResiniferatoxinExperimental Treatment1 Intervention
7.5 mcg, 10 mcg, 12.5 mcg, 15 mcg, or 20 mcg in 5 mL injected once intra-articularly
Group II: ZilrettaActive Control1 Intervention
32 mg in 5 mL injected once intra-articularly
Group III: PlaceboPlacebo Group1 Intervention
5 mL injected once intra-articularly
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Resiniferatoxin
2017
Completed Phase 1
~120
Find a Location
Who is running the clinical trial?
Sorrento Therapeutics, Inc.Lead Sponsor
47 Previous Clinical Trials
1,840 Total Patients Enrolled
3 Trials studying Osteoarthritis
94 Patients Enrolled for Osteoarthritis
Mike Royal, MDStudy DirectorSorrento Therapeutics, Inc.
27 Previous Clinical Trials
1,371 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have significant knee pain caused by osteoarthritis, as determined by your doctor using specific guidelines from the American College of Rheumatology.Your knee is not stable or properly aligned after previous surgery or repair.You have a past of drug or alcohol abuse.You have a knee x-ray or MRI scan with KL grade ≥ 2 in the index knee.You have tried at least two pain medications before, including one NSAID, but they did not work well enough or caused side effects that led to stopping the treatment.You have a lot of pain in your knee that is caused by osteoarthritis. The doctor will use the American College of Rheumatology criteria to determine the severity of your pain.You have tried at least two pain medications before (including one NSAID) but had to stop because they didn't work well or caused side effects.You have tried at least two different pain medications (including one NSAID) but they didn't work well enough or caused too many side effects.You have severe pain in other parts of your body that makes it hard to accurately measure the pain in your knee.You experience moderate to severe pain (rated as 4 or higher on a scale of 0 to 10) while walking for most of the days in the week before the screening.You are allergic or have a strong reaction to capsaicin, chili peppers, lidocaine, or resiniferatoxin.You have been experiencing knee pain for at least 6 months before the screening.You have significant pain in your knee caused by arthritis, as determined by the doctor using specific criteria from the American College of Rheumatology.Your average walking pain score in the past week is 4 or higher on a scale from 0 to 10.You have metal implants or other objects in your knee that cannot be removed.Your knee has been hurting for at least 6 months before the screening.You have experienced knee pain due to osteoarthritis for at least 6 months before the screening.You are willing to abstain from other IA injections or knee surgery for at least 6 months after study treatment unless you elect early discontinuation from the study.
Research Study Groups:
This trial has the following groups:- Group 1: Resiniferatoxin
- Group 2: Zilretta
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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