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Study to Evaluate Resiniferatoxin in Patients With Knee Osteoarthritis Whose Total Knee Replacement Surgery is Delayed | Clinical Trials | Clareo Health

WITHDRAWNPHASE3

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

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

NCT04386980•Sorrento Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+7 more criteria

Key Dates

Start Date

April 1, 2021

Primary Completion Date

June 1, 2022

Completion Date

June 1, 2022

Last Updated

November 9, 2021

Conditions

Osteoarthritis, KneeOsteo Arthritis KneeKnee Pain Chronic

Interventions

Resiniferatoxin

DRUG

Placebo

DRUG

Total Versus Robotic Assisted Unicompartmental Knee Replacement

NCT05290818

Osteo Arthritis KneeArthritis Knee+1 more

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Probiotic Supplements in Osteoarthritis

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Osteoarthritis, Knee

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RECRUITINGPHASE3

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 9, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Total Versus Robotic Assisted Unicompartmental Knee Replacement

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