Frequently Asked Questions

(ACURIAN PROJECT CODE: 1212)
  1. About This Clinical Research Trial
  2. Online screening
  3. Miscellaneous questions
   

I. About This Clinical Trial

Study Questions

What is Osteoarthritis?

A form of arthritis, occurring mainly in people, over the age of 45, that is characterized by chronic degeneration, or "wear and tear", of the cartilage of the joints. Also called degenerative joint disease. It is the most common form of arthritis; about 20 million people in the US have osteoarthritis. OA usually affects more females than males, people with a family history of OA and people with other types of arthritis and people who are obese.

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Who qualifies for these research studies?

Men and Women at least 40 years of age.

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Where are the research sites?

There are approximately 80 centers in the United States that are helping to conduct this study.

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When will I know if I qualify for a study?

If you pass this initial screener, a member of a study doctorís staff will contact you -- they will ask you more questions to further assess if you should participate in this study. If they believe that you should be considered, you will be asked to schedule an appointment at the doctorís office (or clinic) for further evaluations. When you go to the doctorís office, the study doctor and his/her team conduct study related examinations and tests to see if you can be enrolled into this study.

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How long will my participation in the study last, if I qualify?

Each personís participation will be 32-45 days During that time, participants will need to visit the research site 6 times.

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What is the purpose of these research studies?

The purpose of this study is to evaluate the effectiveness and safety of an investigational drug in patients with osteoarthritis of the knee.

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Will I receive the investigational drug or a placebo (a treatment not containing active ingredient)?

If you qualify for the study and decide to participate, there is a chance that you will only receive placebo, an inactive medication. This is a random process (like a flip of a coin) -- neither you nor your study doctor will know which treatment you receive.

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What are the possible side effects of this investigational drug?

The qualified study physician will discuss the potential risks and benefits of this investigational treatment and review the possibility of experiencing any side effects associated with this study medication before you begin the actual study.

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Does my doctor have to give his/her permission?

No, but you may contact your personal physician or you may give the study doctor permission to contact your personal physician.

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Why are you recording this call?

The call is being recorded for quality assurance purposes. Also, if you are a resident of California, the California law SB 1633 requires a recording of the entire conversation whenever a business requests medical information directly from an individual. California law also requires us to keep the recording for three years after the conversation date. The audio recording will be kept in a secure location and will not be shared without your permission or except if required by law.

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How did Acurian get my name?

Acurian is a company that specializes in informing people about clinical research opportunities in their area. Acurian received your name when you provided it either to Acurian at their website, to a third party through a survey in a magazine, a survey you may have received in the mail, or elsewhere. When you provided your name, you also indicated an interest in receiving information about this health condition. Acurian did not receive your information from your doctor or any other health professional, and your confidentiality has not been compromised in any way. You may visit www.acurian.com to view our privacy policy.

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Glossary

Cancer

Any malignant growth or tumor caused by abnormal and uncontrolled cell division; it may spread to other parts of the body through the lymphatic system or the blood stream.

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Cardiovascular Diseases

Arteriosclerosis, angina, high blood pressure, high cholesterol, heart attack, stroke, arrhythmia and heart disease.

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Congestive heart failure

Heart failure simply means that the heart is not pumping blood through the body as well as it should. As the heart's pumping action weakens, blood backs up into the blood vessels around the lungs and causes seepage into the lungs. The fluid causes congestion and makes it hard to breathe. Many people with heart failure also have swollen legs and feet. That is why heart failure is sometimes called congestive heart failure.

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Heart Attack

Damage to the heart muscle due to insufficient blood supply.

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Hepatitis

Hepatitis is an inflammation of the liver, which may be caused by a bacterial or viral infection, parasitic infestation, alcohol, drugs, toxins, or transfusion of incompatible blood. Although many cases of hepatitis are not a serious health threat, the disease can become chronic and sometimes lead to liver failure and death.

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HIV (AIDS)

HIV is a viral infection that gradually destroys the immune system. It is passed from person to person through bodily fluids.

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Hysterectomy

A hysterectomy is an operation to remove the uterus (womb).

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Kidney disease

A disease affecting the kidneys, especially one that requires dialysis. Dialysis is the use of an artificial kidney machine required to keep a person alive.

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Inhaler

An inhaler is a medical device used for delivering medication into the body via the lungs. It is often used in the treatment of asthma

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Liver disease

A disease affecting the liver, such as hepatitis B and hepatitis C.

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Menopause

Menopause is when menstruation permanently stops.

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Osteoarthritis

A form of arthritis, occurring mainly in older persons, that is characterized by chronic degeneration (wear and tear) of the cartilage of the joints. Also called degenerative joint disease.

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Oophorectomy

Removal of the ovaries.

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Pancreatitis

Inflammation of the pancreas

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Parkinsonís disease

A degenerative disorder of the central nervous system that often impairs the sufferer's motor skills and speech.

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Placebo

Placebo is an inactive substance or preparation used as a control in an experiment or test to determine the effectiveness of a medicinal drug.

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Rheumatoid Arthritis

Rheumatoid arthritis is a form of arthritis in which the membranes or tissues lining the joints become inflamed (synovitis). Joint inflammation causes swelling and pain and, over time, may destroy the joint tissues and lead to disability.

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Stroke

The loss or alteration of bodily function that results from an insufficient supply of blood to part of the brain is called a stroke.

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Tubal ligation

A method of female sterilization in which the fallopian tubes are tied during a surgical operation.

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II. Online Screening

What is an online screening questionnaire?

The online screening questionnaire asks a series of relevant health-related questions and compares the responses to the enrollment criteria for this clinical research study to help determine your eligibility to participate in a specific research study.

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What should I do if I have a question about the online screening questionnaire?

If you are unsure about a particular question or do not understand what you are being asked, please select the appropriate help topic link. The Help and Synopsis buttons will always be available if you have questions or concerns while completing the questionnaire. We encourage you to discuss any detailed medical questions with your physician or other healthcare provider. You may also contact us by email or call the toll-free number, which was provided in the message that you received, to complete the screening questionnaire by telephone. Our call center operators are available every weekday between 8 a.m. and 10 p.m. (Eastern time).

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How long will it take to complete the online screening questionnaire?

The length of time required to complete the online screening questionnaire will vary from person to person and may also vary depending on the speed of your Internet connection or browser. For your convenience a progress bar located at the bottom of the page indicates your relative position within the survey, which can be used as an indicator of the length of time remaining until the questionnaire will be complete.

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Getting Around

How do I navigate around the online screening questionnaire?

While completing the online screening questionnaire, please always use the Next and Back buttons provided at the bottom of the screen to move forward and backward through the questionnaire. Please DO NOT use your Internet browser's FORWARD and BACK buttons.

After completing a question, select the Next button to move to the next question; select the Back button to move to a previous question.

The Help and Synopsis buttons will always be available if you have questions or concerns while completing the questionnaire.

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How do I change a response to a specific question?

If you would like to revise a response, select the back button to navigate to that question and revise as necessary.

Please note, however, that the series of questions may change based on any revisions you make to your responses. Therefore, if you revise any response, you will need to recheck your responses for the subsequent questions.

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How will I know if I am eligible to participate in a research study?

If your responses establish that you passed the initial screening for this research study, you will be asked to select from a list of convenient research locations. Your completed questionnaire will then be forwarded to the research location that you choose, and a member of the research study staff there will contact you to schedule an appointment.

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Once I complete the online screening questionnaire, how do I get back onto the Internet?

Once you have clicked on the Submit button and have reached our "Thank you" page, you can follow the link on that page to the Acurian Web site, or you can simply use one of your bookmarks or type in a URL to go to another site on the Internet.

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Techincal Questions

What if I have questions or concerns that are not answered here or elsewhere in the Help section?

We encourage you to discuss any detailed medical questions with your physician or other healthcare provider. You may also contact us by email if you have questions about completing the online screening questionnaire.

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How do I address any technical problems I encounter while completing an online screening questionnaire?

Unfortunately, we occasionally experience technical problems with our servers or online screening questionnaires. From time to time, our servers may become overloaded when too many people try to access a questionnaire at the same time. If you can't access the questionnaire or it takes too long to complete a particular survey, you can always complete the questionnaire at a later time.

If you are experiencing a technical problem, please feel free to contact us by email or call the toll-free number, which was provided in the message that you received, to complete the screening questionnaire by telephone. Our call center operators are available every weekday between 8 a.m. and 10 p.m. (Eastern time).

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Which browser works best?

We recommend using Internet Explorer 5.0 (or subsequent releases) to view our online screening questionnaires. We also encourage AOL users to use the non-AOL version of Internet Explorer when completing our questionnaires because it produces a faster connection and a better overall experience. For your convenience, here is a link to the download of the latest version of Internet Explorer:

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What other computer technology do I need to complete the online screening questionnaire?

All you need is an Internet browser (please see Which browser works best?) and an Internet connection to complete the online screening questionnaire.

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Clinical Research Trials

What is a clinical research trial?

A clinical research trial, or research study, involves volunteers and is conducted by qualified physicians to evaluate an investigational treatment for a specific disease or group of diseases. Before the investigational drug is given to participants in a clinical research trial, it is researched in the laboratory. Clinical research studies provide an effective way to test investigational medicines. All FDA regulated products in widespread use today had to be proven effective and safe in clinical studies, before they could be marketed.

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What are the risks and benefits of participating in a clinical research trial?

Most eligible volunteers enroll in a clinical research trial because they hope that they will personally benefit from the study-related investigational drug or treatment they receive, or because they want to help advance medical science, believing they can help other individuals who may some day benefit from what is learned in the research study. However, there may be no benefits promised if you elect to participate. The research study doctor will discuss the potential risks and benefits with you.

You will be presented with an Informed Consent form that every research study participant must understand and sign before enrolling into the research study. The Informed Consent lists -- in detail -- the most common known risks and side effects of the investigational drug.

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Should I still see my family doctor?

Yes. Participants should see their family doctor for routine medical care.

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Will my family doctor be kept informed of my progress and test results?

We encourage you to talk with the research study doctor about how he/she will involve and/or inform your personal physician. This will only be done with your permission.

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Your Personal Information

How will the information that is collected be used?

Your responses to the screening questions will be compared to the enrollment criteria for this clinical research study to help determine your eligibility to participate in the research study.

Your responses remain confidential and will not be shared with anyone for any purpose other than determining your eligibility for this research study. For more information please read our privacy policy.

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Why do we need your personal information and contact information?

We need to ensure that we are able to provide the most up-to-date personal information and contact information available to the research site that you choose if your responses establish your eligibility to participate in this research study. The research site will need to contact you as quickly as possible to schedule an appointment and will also need to provide any special instructions that might be necessary or helpful for that appointment and any subsequent office visits.

Remember: Acurian will never reveal your personal information or contact information to anyone else for any purpose other than this research study without your explicit permission (see our privacy policy).

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Does anyone have access to my personal information?

Protecting your privacy is important to us. We employ sophisticated technology to protect your personal information, and we will not release your information without your permission. For more detailed information, please review our privacy policy.

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Acurian

What is Acurian?

Acurian is a company that helps potential research study volunteers and caregivers find doctors who are conducting research studies. In this way, Acurian helps to speed up the research process for new investigational medicines. For more information about Acurian and clinical research studies, visit their web site at www.acurian.com.

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Contact information

If you have comments, suggestions, or concerns about the online screening questionnaire, please feel free to contact us.

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III. Miscellaneous questions

What if I have a specific medical question?

We encourage you to discuss any specific medical questions with your physician or other healthcare provider. Your doctor or other healthcare professional is the best source of information to answer your questions.

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Why did I disqualify?

I'm sorry but I am unable to give you the specific reason why you did not pass the initial screening for this research study. The computer program I use determines whether or not you pass this initial screening and it does not allow me to see the details. Individuals qualify or disqualify based on the research study's criteria, which are set up to protect potential participants and answer specific research questions.

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Why did Acurian create a website in my name?

If your letter has a website address that includes your name, do not be alarmed. The website does not actually exist as a webpage. It is simply an address to grab your attention, and when you type it into your web browser, it simply goes to the www.acuriantrials.com website. It is not indexed in any search engines because it is considered a "virtual" (not real) web address. To see for yourself, just type the address into your web browser. Acurian uses the personalized web addresses because it helps to increase the number of people who respond to the letter. Other companies have similar techniques, such as sport uniform companies that print a personís last name on the picture of a football jersey that is for sale in a catalog.

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After you have read these instructions, please close this window to return the online screening questionnaire.