Clinical Trial 40089


New York, NY 10022

Study Summary:

   Protocol TGC12301 is a randomized, double-blinded, placebo-controlled, multi-center phase III study. A total of 510 adults will be enrolled and randomized in a 2:1 manner, with 340 treated subjects and 170 placebo subjects, with radiographically determined stage 2 or 3 primary osteoarthritis of the knee joint. All study subjects will be followed for a period of 24 months, (104 weeks) after injection. During participation in the study, if there is no relief from symptoms, subjects may choose to undergo a surgical procedure including (total knee arthroplasty) 12 months or more after dosing at their own discretion in consultation with the investigator.

Qualified Participants Must:

• Be age 40 and older
• Have Osteoarthritis of the knee
• Have a BMI between 18.5 and 40
• Be able to provide current MRI of target knee

Qualified Participants May Receive:

  • Qualified participants will receive randomization treatment for knee pain by injection.
  • Follow up and assessment of knee after injection for a period of 24 months.
  • Potential Reimbursement if qualified for the study (at discretion of study sponsor. )

Study is Available At:

Ainsworth Institute Of Pain Management
115 East 57th Street
Suite 1210
New York, NY 10022
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If you or someone you care for is interested in participating in this clinical trial and lives within 50 miles of the clinic, please complete the form below and click 'I Am Interested In This Study'

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.