A Double-Blind, Randomized Trial of Intra-Articular injections of 20 mg of Hyalgan® for the Treatment of Knee Pain Due to Osteoarthritis (Three-injection regimen Efficacy and Duration-20 mg/2ml Dose: Tread-20): Sanofi Protocol #L-9385

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Joseph Markenson, MD

Co-Investigators

None

Summary

This is a multi-center trial and 150 patients will be enrolled in 5 sites with 30 patients being enrolled from HSS. The purpose of this study is to evaluate the efficacy of Hyalgan in a treatment cycle of 3 injections (20mg / 2ml) given at weekly intervals. Each patient will have a total of 10 visits over a total of 26 weeks. There will be a screening visit and then 3 weekly visits for the study injections, with 6 follow-up visits to assess joint pain and function. All medications, lab work, x-rays, and medical visits will be provided at no cost to patients who qualify. Travel reimbursement will also be available to those who qualify.

Inclusion Criteria

• Male/Female age 40 and older with knee pain for at least 6 months
• Confirmed osteoarthritis by x-ray in the past 6 months. If no x-ray done in the past 6 months, one will be provided.

Contact Information

Principal Investigator
Joseph Markenson, MD
Tel: 212.606.1261

Study Coordinator
Peggy O'Donohue, RN CCRC
Tel: 212.774.2271
Email: odonohuem@hss.edu

Study Coordinator
Eileen McCullagh, RN ONC, CCRC
Tel: 212.774.2724
Email: mccullaghe@hss.edu

---

posted 7/6/2005