Low Back Pain Clinical Trial
Official title:
True Functional Restoration and Analgesia in Non-Radicular Low Back Pain: a Prospective Double Blind, Placebo-controlled Study of Hydromorphone ER
You are asked to take part in this study because you have chronic, non-radicular low back pain. This study is done to investigate the pain relieving effects of the study drug Exalgo (Hydromorphone ER) for people who experience chronic non-radicular low back pain. The purpose of this research is to look at how the study drug can be used to benefit people who experience this type of pain. This is a phase IV study done to study the safety and effectiveness of the drug. At this point the drug has been approved by the Food and Drug Administration and has been studied in more than 2,000 pain patients in clinical trials, including individuals with low back pain. About 36 subjects will take part in this study.
As a participant in this study, you will be asked to come to the Rehabilitation Institute of
Chicago (RIC), Center for Pain Studies (446 E Ontario St. Suite 1011, Chicago, IL 60611).
Your part in this study will last for 8 weeks and will involve 3 visits to the Rehabilitation
Institute of Chicago and anywhere from weekly phone calls to phone calls every other day.
If you are in this study, you will be placed in one of two study groups: one group will
receive the study drug and one will receive a placebo. You will be assigned a study group by
chance using a process similar to the flip of a coin. This process is called randomization.
Neither you nor the study staff will select the group you will be in. A placebo looks like
the study drug but is an inactive substance that has no medication. Researchers use a placebo
to see if the study drug works better or is safer than not taking anything. You will have a
66% chance of getting the study drug. You will receive placebo at some point during the study
but you will not know whether you are receiving placebo or study drug during the entire
study. However, if you have a medical emergency, the investigators can get this information.
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