We want to find a new treatment option that may work for people with osteoarthritis of the knee.

What is the purpose of the Roccella study?

The main purpose of this study is to look at whether the study drug (compared to placebo) is safe, well-tolerated, and can prevent cartilage degradation and reduce osteoarthritis pain in the knee.

Who can take part in the Roccella study?

You may be able to participate in this study if you meet these criteria*:

  • 40-75 years of age

  • Non-childbearing potential (Women)

  • Diagnosed with osteoarthritis in your knee

  • History of knee pain for at least 6 months and in pain for more than 50% of the time for the past month

  • Surgery of the target knee should not be planned during the study period

*Other criteria will apply.

What will happen during the study?

If you meet initial criteria and decide to join the study, you will participate in 3 periods:

  • Screening Period (5 weeks)

The study doctor and staff will check to see if you qualify to participate.


  • Randomization and double-blind treatment period (52 weeks)

You will be randomly assigned to receive study drug or placebo. You will have a 3 in 4 chance of receiving the active study drug and a 1 in 4 chance of receiving placebo. The placebo looks identical to the study drug, but does not contain any active drug. This study is “double-blind,” meaning neither you nor your study doctor will know which treatment group you are in.


  • Follow-up period (2 weeks)

Study staff experienced in clinical trials will monitor your health throughout the study. Study participation may last up to 61 weeks with at least 10 visits to the study site.

During the study, you will be asked to do the following:

  • Take the study medication as instructed by the study doctor

  • Answer questions about your health

  • Complete MRI and X-ray imaging procedures of targeted knee

  • Provide urine and blood samples at study visits

  • Follow all directions from the study staff

  • Attend all scheduled study visits

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