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Study of Resiniferatoxin for Knee Pain in Moderate to Severe Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03542838
Recruitment Status : Completed
First Posted : May 31, 2018
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Sorrento Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Pain, Knee Drug: Resiniferatoxin Drug: Saline Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 12, 2018
Actual Primary Completion Date : April 13, 2020
Actual Study Completion Date : February 11, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Resiniferatoxin
Resiniferatoxin is administered as a one-time dose, intra-articularly at a dose level of 5ug, 12.5ug, 20ug, 25ug, or 30ug.
Drug: Resiniferatoxin
Resiniferatoxin is a compound purified from natural sources.
Other Name: RTX

Placebo Comparator: Saline
Saline is administered as a one-time dose, intra-articularly.
Drug: Saline
Saline is a normal physiological solution
Other Name: Normal saline




Primary Outcome Measures :
  1. Safety measurement [ Time Frame: baseline through week 52 ]
    Incidence and severity of adverse events


Secondary Outcome Measures :
  1. Improvement of knee pain when walking [ Time Frame: baseline through week 52 ]
    Improvement in pain score versus baseline using the WOMAC Osteoarthritis Index question A1 (pain on walking, 11-point numerical rating scale)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Age: 35 years to 85 years
  2. Diagnosis of moderate to severe pain due to OA: Moderate to severe osteoarthritis, based on American College of Rheumatology (ACR) criteria
  3. BMI < 45 kg/m2
  4. Pain in the target knee has been treated with at least 2 analgesic agents, including at least one NSAID
  5. Prior failure in at least two prior analgesic agents (at least one NSAID)
  6. Willing to abstain from other intra-articular treatments of the knee or any knee surgery for at least 24 weeks after treatment
  7. Ability to comply with the study and give informed consent
  8. 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
  9. If on NSAIDs, be on a stable analgesic regimen for at least 4 weeks prior to injection
  10. If on pain regimens other than opioid medication or NSAIDs, be on a stable regimen for at least 30 days
  11. Is in good general health and is considered to have a physical status that is American Society of Anesthesiologists (ASA) category ≤ 3
  12. Able to comply with study procedures, including the recording of daily questionnaires

Exclusion Criteria:

  1. Has evidence or history of a coagulopathy or hemostasis problem at Screening or Baseline (Day 1)
  2. Treatment knee injections with corticosteroids within 30 days or hyaluronic acid within 3 months prior to the procedure
  3. 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
  4. 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
  5. Concurrent use of opioids for indications other than knee pain
  6. History of substance abuse
  7. Has an allergy or hypersensitivity to chili peppers, capsaicin, resiniferatoxin or radiographic contrast agents
  8. Female subjects who are pregnant at Screening or are planning on becoming pregnant, or are currently breastfeeding
  9. Subjects with any medical condition or comorbidities that could adversely impact study participation or safety, conduct of the study, or interfere with pain assessments
  10. Subjects who have participated in a clinical study of an investigational drug within 4 half-lives of Screening or are scheduled to receive and investigational agent while participating in this study
  11. Sensory peripheral neuropathy that is CTCAE Grade 2 or higher at Screening
  12. Arterial or venous thrombi, myocardial infarction, admission for unstable angina, cardiac angioplasty, or stenting within 12 months prior to Screening
  13. Evidence or history of any hemorrhage or bleeding event that is higher than CTCAE Grade 1 within 4 weeks prior to injection.
  14. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or C. Positive tests for HIV-1 or -2 antibodies, hepatitis B surface antigen, or hepatitis C antibodies.
  15. Concurrent medical or arthritic conditions that could interfere with evaluation of the index knee joint including fibromyalgia, rheumatoid arthritis, or other inflammatory arthropathies affecting the knee joint
  16. Subjects with significant pain in other joints may be excluded at the discretion of the investigator
  17. Subject has undergone arthroscopic or open surgery to the knee within 6 months of the planned injection day
  18. Subject has undergone replacement surgery of the treatment knee
  19. Presence of surgical hardware or other foreign bodies in the treatment knee

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03542838


Locations
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United States, California
Snibbe Orthopedics
Los Angeles, California, United States, 90048
United States, Florida
University of Miami/Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Texas
Hermann Drive Surgical Hospital
Houston, Texas, United States, 77004
Sponsors and Collaborators
Sorrento Therapeutics, Inc.
Investigators
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Study Director: Monica Luchi, MD Sorrento Therapeutics
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Responsible Party: Sorrento Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03542838    
Other Study ID Numbers: PTVA OA-001
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases