Study of Resiniferatoxin for Knee Pain in Moderate to Severe Osteoarthritis

NCT03542838 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: PTVA OA-001
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Osteoarthritis, Knee; Pain, Knee

Outcome Measures

Primary Outcomes (1)

• Safety measurement

  Incidence and severity of adverse events

  baseline through week 52

Secondary Outcomes (1)

• Improvement of knee pain when walking

  baseline through week 52

Study Arms (2)

Resiniferatoxin

EXPERIMENTAL

Resiniferatoxin is administered as a one-time dose, intra-articularly at a dose level of 5ug, 12.5ug, 20ug, 25ug, or 30ug.

Drug: Resiniferatoxin

Saline

PLACEBO COMPARATOR

Saline is administered as a one-time dose, intra-articularly.

Drug: Saline

Interventions

Resiniferatoxin DRUG

Resiniferatoxin is a compound purified from natural sources.

Also known as: RTX

Resiniferatoxin

Saline DRUG

Saline is a normal physiological solution

Also known as: Normal saline

Saline

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 35 years to 85 years
• Diagnosis of moderate to severe pain due to OA: Moderate to severe osteoarthritis, based on American College of Rheumatology (ACR) criteria
• BMI \< 45 kg/m2
• Pain in the target knee has been treated with at least 2 analgesic agents, including at least one NSAID
• Prior failure in at least two prior analgesic agents (at least one NSAID)
• Willing to abstain from other intra-articular treatments of the knee or any knee surgery for at least 24 weeks after treatment
• Ability to comply with the study and give informed consent
• If on an opioid medication, stable dose for at least 4 weeks prior to injection with no increase in dose leading up to study injection
• If on NSAIDs, be on a stable analgesic regimen for at least 4 weeks prior to injection
• If on pain regimens other than opioid medication or NSAIDs, be on a stable regimen for at least 30 days
• Is in good general health and is considered to have a physical status that is American Society of Anesthesiologists (ASA) category ≤ 3
• Able to comply with study procedures, including the recording of daily questionnaires

You may not qualify if:

• Has evidence or history of a coagulopathy or hemostasis problem at Screening or Baseline (Day 1)
• Treatment knee injections with corticosteroids within 30 days or hyaluronic acid within 3 months prior to the procedure
• If on opioid analgesics, an upper limit of 30 mg/day of oral morphine sulfate, 20 mg/day of oxycodone, 30 mg/day of hydrocodone, or 300 mg/day of tramadol, or equivalent
• Any of the following lab abnormalities within one week of the treatment day:
• Platelet count \<100,000 cells/mm3
• Total neutrophil count \<1500 cells/mm3
• Serum creatinine ≥ 1.5 x ULN
• Alanine aminotransferase (ALT) \> 3.0 x ULN
• Aspartate aminotransferase (AST) \> 3.0 x ULN
• Alkaline phosphatase \> 2.0 ULN
• Bilirubin \> 1.5 x ULN
• INR \> 1.5 x ULN
• Temperature ≥ 100.4°F or other evidence of an infection
• Concurrent use of opioids for indications other than knee pain
• History of substance abuse

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

Study Sites (4)

Snibbe Orthopedics

Los Angeles, California, 90048, United States

Location

University of Miami/Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Hermann Drive Surgical Hospital

Houston, Texas, 77004, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Interventions

resiniferatoxin; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Monica Luchi, MD

  Sorrento Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Except for the sentinel subject, the treatment assigned to each subject in the dose-escalation cohorts is blinded to the subject, investigators, and sponsor study team. The sentinel subject, the first subject in each dose-escalation cohort, is dosed with resiniferatoxin in an open-label fashion. Subjects in the dose-escalation cohorts who received placebo may receive resiniferatoxin in an open-label fashion after unblinding. All subjects in the dose-expansion cohorts are dosed with resiniferatoxin in an open-label fashion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: May 31, 2018
• Study Start: July 12, 2018
• Primary Completion: April 13, 2020
• Study Completion: February 11, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)