Stryker OP-1 Study
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What is the Stryker OP-1 Study?
This is a Phase I study of an investigational drug called osteogenic protein-1 (OP-1) for treatment of osteoarthritis of the knee. The study is sponsored by Stryker Biotech and is being conducted at UNC-CH by Dr. Beth Jonas, and at two other medical centers.
What did we learn?
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The study will determine the safety and tolerability of OP-1 at four different dose levels when injected into the knee of subjects with osteoarthritis. It will also help to determine the most effective dose level and how effective the drug is in reducing the symptoms of knee osteoarthritis.
Who is Participating?
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To participate you must be at least 40 years of age and have had osteoarthritis for at least 6 months, and pain in at least one knee on most days of the last month. You should be in fairly good health, except for your arthritis.
What is Involved?
First you will be seen for a screening visit where you will have a physical exam, an ECG, x-rays of your knees, and some blood tests done. There will be some questionnaires about how your arthritis affects you. This visit will determine if you qualify to participate in the study.
If you qualify, you will receive an injection in your knee at the second visit. Three people out of four will receive the study drug and one will receive a placebo (something that looks like the study drug but has no active ingredient). This visit also involves answering some questionnaires, having an exam of your knee and some blood tests.
After the injection, there are follow-up visits at 1, 2, 4, 8, 12, and 24 weeks to evaluate your response to the medication. Your knee will be examined at each visit and some questionnaires and blood tests will be completed. At some visits, x-rays and ECG will be repeated. You will be asked to report any unusual symptoms that you notice over this period of time.
You will receive a monetary compensation for your participation.
How will I Benefit?
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You will be given the results of your ECG, x-rays, and blood tests and can share these with your doctor if you wish.
You may have some improvement in your arthritis symptoms, but this cannot be guaranteed.
You will be making a contribution to knowledge about this investigational medication which may affect how osteoarthritis is treated in the future.
Contact Information
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Call Pat at (919) 966-8350 or Diane at (919) 966-0545, or email at pcummins@med.unc.edu