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Study to Evaluate Resiniferatoxin in Patients With Knee Osteoarthritis Whose Total Knee Replacement Surgery is Delayed

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ClinicalTrials.gov Identifier: NCT04386980
Recruitment Status : Not yet recruiting
First Posted : May 13, 2020
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Sorrento Therapeutics, Inc.

Brief Summary:
Efficacy and safety study of resiniferatoxin versus placebo to manage pain in patients with knee osteoarthritis whose TKR surgery is delayed

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Osteo Arthritis Knee Knee Pain Chronic Drug: Resiniferatoxin Drug: Placebo Phase 3

Detailed Description:
This study evaluates the efficacy and safety of intra-articular resiniferatoxin (RTX) versus placebo to manage pain in patients with osteoarthritis of the knee whose Total Knee Replacement surgery is delayed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Multi-center, Blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intra-articular Resiniferatoxin Versus Placebo to Manage Pain in Patients With Osteoarthritis of the Knee Whose Total Knee Replacement Surgery is Delayed
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Resiniferatoxin
12.5 ug of Resiniferatoxin in 5 mL volume administered once intra-articularly
Drug: Resiniferatoxin
Resiniferatoxin is a compound purified from natural sources.
Other Name: RTX

Placebo Comparator: Placebo
5 mL of diluent in normal saline administered once intra-articularly
Drug: Placebo
Diluent in normal saline




Primary Outcome Measures :
  1. Change in WOMAC pain and function subscales combined score [ Time Frame: Baseline to Week 12 ]
    Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 3.1 numerical rating scale (NRS) [0-10 scale] Pain and Function combined score. The combined score ranges from 0 to 220; a higher score indicates greater severity of disease.


Secondary Outcome Measures :
  1. Safety of RTX: Incidence and severity of adverse events [ Time Frame: Baseline through Week 12 ]
    Incidence and severity of adverse events

  2. Change in analgesic usage [ Time Frame: Baseline to Week 4, Week 8, Week 12 ]
    Change in analgesic medication usage as reported by subjects

  3. Change in WOMAC pain and function subscales combined score [ Time Frame: Baseline to Week 4, Week 8 ]
    Change in the WOMAC 3.1 NRS [0-10 scale] Pain and Function combined score. The combined score ranges from 0 to 220; a higher score indicates greater severity of disease.

  4. Patient Global Impression of Change (PGIC) in index knee pain [ Time Frame: Baseline to Week 4, Week 8, Week 12 ]
    Rating of change in index knee pain using the 7-point PGIC scale where 1 = very much improved and 7 = very much worsened.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to give informed consent and comply with the study
  • Diagnosis of osteoarthritis (OA) in the index knee
  • Combined WOMAC A (pain) and C (function) subscale score of ≥ 23 at screening, using the WOMAC 5-point Likert scale
  • Eligible for total knee replacement (TKR) surgery but unable to schedule surgery or undergo scheduled surgery
  • In good general health; American Society of Anesthesiologists (ASA) physical status category ≤3
  • Willing to use contraception for at least 30 days after receiving the study drug
  • Able to understand and complete study-related forms and adequately communicate with the Investigator and site staff

Exclusion Criteria:

  • Pre-existing osteonecrosis, subchondral insufficiency fracture, or knee pain attributable to disease other than OA which may confound the ability to assess response to treatment
  • Concurrent medical or arthritic conditions that could interfere with evaluation of the index knee joint including, metabolic diseases, gout/pseudogout, hemochromatosis, acromegaly, fibromyalgia, rheumatoid arthritis, or other inflammatory arthropathies affecting the knee joint
  • Participants with significant pain in the back or other joints (ex. hip pain) which may confound discrimination of pain assessment in index knee, as judged by the Investigator
  • Undergone arthroscopic surgery of the index knee within 6 months of study drug administration, or open surgery to the index knee within 24 months of study drug administration
  • Undergone replacement surgery of the index knee
  • Presence of surgical hardware or other foreign bodies in the index knee
  • Index knee injections with corticosteroids within 30 days, or hyaluronic acid within 3 months, or platelet-rich plasma within 6 months prior to study drug administration.
  • Concurrent use of opioids for indications other than knee pain
  • Arterial or venous thrombi (including stroke), myocardial infarction, hospital admission for unstable angina, cardiac angioplasty, or stenting within 12 months prior to Screening.
  • Sensory peripheral neuropathy in the distal aspect of the target limb that is of moderate severity or higher at Screening
  • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or hepatitis C; positive tests for HIV-1 or -2 antibodies, hepatitis B surface antigen, or hepatitis C antibodies
  • Specified laboratory abnormalities within 1 week of study drug administration
  • History within the past 2 years of substance abuse, including alcohol
  • Allergy or hypersensitivity to chili peppers, capsaicin, resiniferatoxin, acetaminophen, tramadol, radiographic contrast agents, or any of the agents to be used for sedation, anesthesia or nerve block on the day of study drug administration
  • Female participants who are pregnant, planning on becoming pregnant within 30 days of receiving study drug, or are breastfeeding at Screening
  • Any medical condition or medical comorbidities that, in the Investigator's opinion, could adversely impact study participation or safety, conduct of the study, or interfere with pain assessments
  • Participated in a clinical study of an investigational drug within 4 half-lives of Screening or are scheduled to receive an investigational agent (therapy or device) while participating in this study

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): NCT04386980


Sponsors and Collaborators
Sorrento Therapeutics, Inc.
Investigators
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Study Director: Monica Luchi, MD Sorrento Therapeutics, Inc.
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Responsible Party: Sorrento Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04386980    
Other Study ID Numbers: STI-RTX-3004
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
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
Keywords provided by Sorrento Therapeutics, Inc.:
osteoarthritis
knee pain
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases