Research Study Summary
Bothered by Arthritis? Concerned About Heart Disease?
The PRECISION Study will compare 3 approved medicines commonly used to treat pain in people who have osteoarthritis (OA) or rheumatoid arthritis (RA). The 3 medicines are
- Celecoxib (brand name Celebrex)
- Ibuprofen (brand names include Advil, Medipren, Motrin, and Nuprin)
- Naproxen (brand names include Aleve, Anaprox, Naprelan, and Naprosyn)
As a participant in The PRECISION Study, you will receive 1 of the 3 study medications chosen at random at no charge. You will have a 33% chance of receiving any 1 of the study medicines. You will not know which study drug you are taking, nor will any of the study doctors or staff. You will continue to take the same medicine throughout the study. All 3 drugs are approved pain relievers called nonsteroidal anti-inflammatory drugs, or NSAIDs. Doctors refer to ibuprofen and naproxen as traditional NSAIDs, but they refer to Celebrex as a COX-2 inhibitor. That's because Celebrex blocks (or inhibits) a certain enzyme in the body called COX-2 that causes pain and inflammation.
Recently, there have been some questions raised about the safety of both COX-2-selective inhibitors and traditional NSAIDs in people who have or at high risk for heart disease. The PRECISION Study will help answer these questions. The study will help doctors learn more about the long-term safety of these medicines on the heart. The PRECISION Study will help provide the information doctors need so they can choose the most appropriate pain reliever for their patients with OA or RA who have or are at high risk for heart disease.
Visit 1: Screening Visit
Your first visit is called the screening visit. At this visit, the study doctor will make sure you are eligible to participate in the study. You will be given a study-related physical examination. The study doctor will ask you questions about your health and medical history, check your blood pressure and heart rate, and perform a blood test. If you qualify for the study, your next visit will be scheduled.
Visit 2: Randomization Visit
Congratulations. During visit 2 you will have officially joined The PRECISION Study. This visit must take place no more than 3 weeks after your screening visit. The study doctor will check your blood pressure and heart rate. You will undergo a blood test and an electrocardiogram (also called an ECG), a test that measures your heart activity. The study doctor will see how much pain your arthritis is causing and how it interferes with your daily activities. If you are a woman able to have children, you will have a pregnancy test.
Visit 2 is the randomization visit. That's because, at this visit, you will be randomly assigned to receive 1 of the 3 study medicines. You will not know which study drug you are taking, nor will any of the study doctors or staff. You will continue to take the same medicine throughout the study. Besides receiving 1 of the 3 study pain relievers, you will also receive Nexium (also called esomeprazole) at no charge. The Nexium is given to help with any stomach or intestinal problems.
Follow-up Study Visits
After the randomization visit, you will have 5 more study visits during the first year in the study: at months 1, 2, 4, 8, and 12. After the first year, follow-up visits are scheduled every 6 months. These visits will continue until you reach month 42 or until the study concludes, whichever occurs first. During each follow-up visit, the study doctor may increase or decrease the dose of your study medicine to make sure your arthritis is controlled.
At each follow-up visit, the study doctor will check your blood pressure and heart rate. You will also undergo a blood test. The study doctor will talk to you about your arthritis and ask you to complete some questionnaires. The study doctor will want to know how much pain your arthritis is causing and how it is interfering with your everyday life.
At your final visit in the study, you will have a study-related physical examination.
Benefits of Participating
By participating in The PRECISION Study, you will
- Obtain study-related medical care throughout the study
- Receive study medication at no charge
- Help others by contributing to medical research
Please contact us to see if you qualify
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