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.
You may be able to participate in this study if you meet these criteria*:
*Other criteria will apply.
If you meet initial criteria and decide to join the study, you will participate in 3 periods:
The study doctor and staff will check to see if you qualify to participate.
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.
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:
Answering a few questions can help determine if participating in the Roccella study may be an option for you. If you qualify, the information you provide will be sent to the study site nearest you.