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Study of Resiniferatoxin for Knee Pain in Moderate to Severe Osteoarthritis

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

Purpose of Study

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.

Eligibility

Age:
35 - 85
Sex:
All

Key Inclusion / Exclusion Criteria

Inclusion Criteria:

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
Has an allergy or hypersensitivity to chili peppers, capsaicin, resiniferatoxin or radiographic contrast agents
Female subjects who are pregnant at Screening or are planning on becoming pregnant, or are currently breastfeeding
Subjects with any medical condition or comorbidities that could adversely impact study participation or safety, conduct of the study, or interfere with pain assessments
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
Sensory peripheral neuropathy that is CTCAE Grade 2 or higher at Screening
Arterial or venous thrombi, myocardial infarction, admission for unstable angina, cardiac angioplasty, or stenting within 12 months prior to Screening
Evidence or history of any hemorrhage or bleeding event that is higher than CTCAE Grade 1 within 4 weeks prior to injection.
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.
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
Subjects with significant pain in other joints may be excluded at the discretion of the investigator
Subject has undergone arthroscopic or open surgery to the knee within 6 months of the planned injection day
Subject has undergone replacement surgery of the treatment knee
Presence of surgical hardware or other foreign bodies in the treatment knee

Conditions:

Arthritis

Status:

Completed

Phase:

Phase 1

Study ID

NCT03542838

Read Detailed Summary

Start Date / End Date:

12/07/2018 -

Enrollment:

94

Full Details:

https://clinicaltrials.gov/ct2/show/NCT03542838

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4 Study Locations

United States

Snibbe Orthopedics
Los Angeles, California, 90048
United States


University of Miami/Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States


Brigham & Women’s Hospital
Boston, Massachusetts, 02115
United States


Hermann Drive Surgical Hospital
Houston, Texas, 77004
United States


Study Locations Map: