About the Study
The purpose of this study is to evaluate the effectiveness (how well the study drug works) and long-term safety of the study drug in people with leg pain due to a lumbar disc herniation. Participants will be monitored for 1 year after they are either given a single study drug treatment or a placebo. The placebo looks like the study drug treatment but does not contain any active ingredients.
Throughout the study you will have various tests and examinations done and will be asked questions about your overall quality of life, pain level of your leg and lower back, recent medications, injuries, and illnesses. In some circumstances, repeat tests and/or examinations (including laboratory, X-ray, and/or MRI tests) may be necessary.
This study is “double blinded,” which means that neither you nor the study doctor will know if you received the study drug or placebo. The study treatment you are given will be decided randomly, like tossing a coin. About 50% (half) of participants will receive the study drug treatment, and about 50% (half) will receive the placebo.