OA Drug Clinical Trial (advertised on TV)

http://www.thepainstudy.com/faq.html (seems to be J&J)

If you have PAIN of the HIP or KNEE due to osteoarthritis
and are awaiting Joint Replacement Surgery CLICK HERE

If you suffer from LOW BAK PAIN or pain in the KNEE or
HIP due to Osteoarthritis CLICK
HERE


About These Studies

There are three similar studies being conducted to evaluate the safety
and effects of treatment with an investigational oral opioid pain
medication compared to taking an approved opioid pain medicine.

One of the studies includes a group taking capsules not having the
opioid medication, however, this study allows your usual non-opioid
pain medication to be taken throughout the study
The other studies evaluate the safety and effects of treatment with the
investigational oral opioid pain medication compared to taking an
approved opioid pain medicine
We are seeking clinical research volunteers to join a study of an
investigational pain medication for men or women between 18 and 80
years old who have osteoarthritis and are candidates for hip or knee
joint surgery.

We are also seeking volunteers who are at least 18 years old with low
back pain, hip or knee pain from Osteoarthritis to join a similar study
of the same investigational pain medication.

These studies will last 4 weeks or 4 months or 13 months depending on
your qualifications for participation and the particular study you are
interested in.



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Becoming a Volunteer

A clinical trial is a medical research project. It is carefully
designed to learn more about a new treatment. All clinical trials are
conducted in accordance with the Declaration of Helsinki and ICH/GCP
Guidelines. Healthcare Authorities, such as Ethics Committees are
involved in the clinical trial process to ensure patient safety.

Clinical trials have the potential to:

Lead to new or better treatments
Lead to improved quality of life
Provide new medical information
Why Should You Participate in a Clinical Trial?
You may get involved in a clinical trial because you are suffering from
a disease for which an effective treatment does not currently exist. Or
you may join a clinical trial hoping to improve your medical condition
and/or quality of life. Or maybe you simply want to help in the
advancement of science.

If you are considering participation in a clinical trial, we encourage
you to discuss any questions or concerns you may have with your doctor.
Your decision is voluntary and should be based on personal needs and
interests.

Making the Decision to Participate in a Clinical Trial
By taking part in a clinical trial, you are contributing to the
development of better treatments which may help others in the future.
Choosing to participate in a clinical trial is an important personal
decision.

Your Participation is Confidential
Your personal and medical information that is collected for the trial
is stored in a way that your identity always remains confidential.

What Happens During a Clinical Trial?
You will be asked to read and sign an informed consent form before your
participation begins. This is a detailed document explaining all
aspects of the trials.

Before making this important decision, each participant will be given a
full explanation of the clinical trial by the doctor, including:

Whether the clinical trial is right for you.
The possible benefits and risks.
Your rights and responsibilities as a participant.
Tests and examinations that may be required, such as having a blood
sample taken or blood pressure measured.
Whether or not the trial design includes a placebo.
Taking part in a clinical trial may provide the opportunity to:

Use a new medicine only available within a clinical trial.
Receive specialized/focused medical care associated with the clinical
trial by a medically qualified doctor.
On the other hand, the following may happen:

The trial medicine may not be of benefit to you.
Your visits to the doctor may need to be longer and more frequent.
You may experience unwanted effects from the trial medicine.
What Happens After a Clinical Trial?
After clinical trial participation has ended, the doctor may discuss
future treatments. All of the information that is collected during the
clinical trial will be studied and analyzed to learn more about the new
medicine or treatment.

The information collected will be sent to the regulatory authorities
for review and approval. Upon approval, the medication may be made
commercially available to patients.

Your Safety is Our Top Priority
Your safety is the number one priority in a clinical trial, and your
condition will be closely monitored.

Therefore, your doctor:

Will ask you to take your trial medication as prescribed and to attend
all your scheduled visits.
Needs to know about any changes in your condition no matter how minor
they may seem to you.
Will tell you about any new information that may affect your
participation in the clinical trial.
You have the right to leave the clinical trial at any time and for any
reason, and this will not affect the medical care you receive from the
trial doctor.



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Frequently Asked Questions

Q: What is Osteoarthritis?
A: Osteoarthritis (OA) is common and widely distributed in both men and
women. OA involves the breakdown of joint cartilage, the flexible
material that naturally cushions the ends of knee, hip, and other
joints. OA is different from Rheumatoid Arthritis (RA). RA is an
autoimmune disease involving inflammation of the lining of joints and
other internal organs. RA affects the whole body as well as the joints.
Many factors can be involved in the development of Osteoarthritis.
While increasing age is a risk factor, OA is not an inevitable part of
aging. OA is usually diagnosed by history and physical exam. The
diagnosis is confirmed by X-ray. Typical symptoms include pain,
stiffness, and limited range of motion in the affected joint.

Q: What is the Purpose of These Studies?
A: There are three similar studies being conducted to evaluate the
safety and effects of treatment with an investigational oral opioid
pain medication compared to taking an approved opioid pain medicine.
One of the studies includes a group taking capsules not having the
opioid medication, however, this study allows your usual non-opioid
pain medication to be taken throughout the study. The other studies
evaluate the safety and effects of treatment with the investigational
oral opioid pain medication compared to taking an approved opioid pain
medicine. The studies will last about 2 weeks or 4 months or 13 months
depending on your qualifications for participation and the particular
study you are interested in.

Q: Who May Qualify for the Studies?
A: We are seeking clinical research volunteers to join a study of an
investigational pain medication for men or women between 18 and 80
years old who have osteoarthritis and are candidates for hip or knee
joint surgery. We are also seeking volunteers who are at least 18 years
old with Low Back Pain, hip or knee pain from Osteoarthritis to join a
similar study of the same investigational pain medication.

Q: Who is Paying for These Studies?
A: The study doctor or study center is being paid by the pharmaceutical
company that is providing the study medications for this study. If this
study is determined to be a good match for you after you take the
pre-screening survey on this today, your information will be sent to a
study doctor near you who can give you additional details about study
supporters.

Q: May I Be Excluded From These Studies?
A: Researchers need to evaluate the study medication in people whose
medical histories are quite similar. This helps the researchers
determine if the study medication is working. Some of the answers you
give to the questions asked on this website may indicate that the
study's criteria do not fit your profile and you are not a good match
for any of these current studies.

Q: Can women participate in the study?
A: Women are eligible for these studies if they are not lactating,
pregnant, or planning to become pregnant. Women who are able to have
children must consent to use a medically acceptable birth control
method during the study. The birth control options for these studies
are: oral contraceptives (like "the pill"), contraceptive
injections, intrauterine devices, double-barrier methods (diaphragm or
condom plus spermicidal cream), contraceptive patches, or male partner
sterilization.

Q: When Will I know if I am Eligible?
A: You may complete the prescreening process on this website or by
calling the study toll-free number. All final decisions regarding
eligibility will be made by the study center in your area.How is My
Medical Information Kept Confidential? Reasonable steps will be taken
to keep any information you share with me confidential as required by
law. With your permission, information collected for this study will be
given to medical personnel at a clinic in your area. If you wish to
hear our Privacy Policy Notice, you may dial toll-free: 1-888-898-7425,
extension 2038.

Q: Are the study medication and medical care free?
A: Should you qualify and enroll, you will receive study medication and
study related evaluations at no charge. You may be paid for parking and
travel costs.

Q: Will I get paid to participate in the study?
A: Some local study sites may reimburse incidental expenses associated
with participation such as parking or travel costs. If you complete the
telephone questionnaire and pre-qualify based on this initial
assessment, the local study center will be able to answer your specific
questions about study payments.