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CNTX-4975-05 in Subjects with Moderate to Severe Osteoarthritis Knee Pain

Title A Randomized, Double-Blind, Placebo-Controlled, Single Injection, 52-Week Study to Evaluate the Efficacy and Safety of an Intra-articular Injection of CNTX-4975-05 in Subjects with Chronic, Moderate-to severe Osteoarthritis Knee Pain
Therapeutic Area Osteoarthritis
Principal Investigator Steven C. Vlad, MD, PhD
Min Age 40 Years
Max Age 95 Years
Gender All
Contact Rheumatology Research Team
617 636-5727
arthritisresearch@tuftsmedicalcenter.org

Overview

The study evaluates the analgesic efficacy on pain with walking of a one-time knee injection for patients with moderate to severe knee osteoarthritis. CNTX-4975-05 is the investigational drug that has not been approved by the FDA. The study drug is a long-acting, non-opioid analgesic drug candidate designed to provide pain relieve. Subjects will be randomly assigned to one of two groups: study drug group, or a placebo group.

Study Details

Inclusion Criteria

  • Subject must have knee osteoarthritis
  • Subject must be willing to complete a daily electronic diary on knee pain and stiffness
  • Subject must have a BMI ≥ 45 kg/m²

Exclusion Criteria

  • Subject who is breastfeeding or pregnant
  • Subject who uses topical medication for knee osteoarthritis pain during the trial
  • Subject with a knee replacement surgery, or a recent open surgery of the knee

Study Requirements

The Centrexion osteoarthritis research study entails a total of 12 visits to Tufts Medical Center over a period of approximately one year. Five of the visits will require blood and urine collection, and the first visit will require an X-ray of both knees. The one-time knee injection will occur after two approved screening visits.