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A Phase 3 Study to Evaluate the Efficacy and Safety of Resiniferatoxin for Pain Due to Osteoarthritis of the Knee | Clinical Trials | Clareo Health

WITHDRAWNPHASE3

A Phase 3 Study to Evaluate the Efficacy and Safety of Resiniferatoxin for Pain Due to Osteoarthritis of the Knee

A Phase 3 Placebo-controlled Study to Evaluate the Efficacy and Safety of Intra-articular Administration of Resiniferatoxin Versus Placebo for the Treatment of Moderate to Severe Pain Due to Osteoarthritis of the Knee

NCT04044742•Sorrento Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This study evaluates the efficacy and safety of intra-articular injection of resiniferatoxin in patients with moderate to severe knee pain due to osteoarthritis.

Detailed Description

This study is to evaluate the analgesic efficacy and safety of resiniferatoxin administered intra-articularly to subjects with moderate to severe knee pain due to osteoarthritis (OA).

Eligibility

Age

35 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female 35 to 85 years of age (inclusive).
•Diagnosis of moderate to severe pain in the index knee due to OA.
•Pain in the non-index knee is less than pain in the index knee.
•Body mass index ≤40 kg/m².
•Experienced treatment failure with at least 2 prior categories of therapies.
•Able to understand and complete study-related forms and communicate with the Investigator and/or site staff.

Exclusion Criteria

•Evidence or history of a serious coagulopathy or hemostasis problem, such as inherited bleeding disorders or thrombocytopenia.
•History of or current condition of poorly controlled hypertension, QTc prolongation, history of risk factors for Torsades de Pointes, or family history of long QT syndrome; or is using concomitant medications that prolong the QT interval.
•Received index knee injections with corticosteroids within 30 days, or hyaluronic acid within 3 months, or platelet-rich plasma within 6 months prior to the injection day.
•Pre-existing osteonecrosis, subchondral insufficiency fracture, severe bone on bone OA, or knee pain attributable to disease other than OA.
•Instability or misalignment in the index knee.
•Concurrent use of opioids or indications other than knee pain.
•History within the past 2 years of substance abuse, including alcohol.
•Allergy or hypersensitivity to chili peppers, capsaicin, resiniferatoxin, acetaminophen, tramadol, or radiographic contrast agents.
•Female participants who are pregnant, planning on becoming pregnant, or currently breastfeeding.
•Any medical condition or comorbidities that, in the Investigator's opinion, could adversely impact study participation or safety, conduct of the study, or interfere with pain assessments.
+7 more criteria

Key Dates

Start Date

December 1, 2020

Primary Completion Date

March 1, 2023

Completion Date

March 1, 2023

Last Updated

November 9, 2021

Conditions

Osteoarthritis, KneeKnee Pain Chronic

Interventions

Resiniferatoxin

DRUG

Placebo

DRUG

Probiotic Supplements in Osteoarthritis

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Osteoarthritis, Knee

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Osteoarthritis, Knee

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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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A Phase 3 Study to Evaluate the Efficacy and Safety of Resiniferatoxin for Pain Due to Osteoarthritis of the Knee

Inclusion Criteria

Exclusion Criteria

Probiotic Supplements in Osteoarthritis

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