A Clinical Study for Those with Sciatica or Leg Pain from a Herniated Disc Is Now Enrolling
GLEN BURNIE, Md., June 24, 2019 /PRNewswire/ -- Explore other options!
A non-steroidal, non-opioidal investigational study medication, already approved for use in Japan [Hernicore®], for those with sciatica or leg pain from a herniated lumbar disc is now being evaluated in a clinical research study in the United States, The Discovery 6603 Study. The study drug, SI-6603, is an investigational drug in the United States and is not yet approved by the Food and Drug Administration. In a Phase 3 study in 163 Japanese subjects, a total of 82 and 81 Japanese subjects received a single injection of SI-6603 or placebo. A single injection of SI-6603 into the nucleus pulposus reduced nerve root compression by reducing disc pressure and volume of herniation, resulting in less leg pain. This clinical research study, the Discovery 6603 Study, is for people who have not responded to other conservative treatments and who are candidates for surgery and is administered as a single injection of SI-6603 and compared with a control injection, (an injection that contains no medication.) One out of two study participants will receive the active study medication.
The Discovery 6603 Study plans to enroll 320 people aged 30 to 70 years old, who have been diagnosed with leg pain from a herniated lumbar disc. Those who qualify for and join the Discovery 6603 Study will see the Study Doctor up to 11 times over 12 months. Study-related exams, study-related diagnostic tests, and the investigational study medication are provided at no charge. Study participants may be compensated for their time and travel to the study location.
Millions of Americans are affected by sciatica or leg pain from a herniated lumbar disc and often resort to common treatments that contain steroids or opioids.
The Discovery 6603 Study is being conducted at:
For more information about the Discovery 6603 Study and to see if you or someone you love may qualify, please call 877-770-1411 or visit www.TheDISCoveryStudy.com.
View original content to download multimedia:http://www.prnewswire.com/news-releases/a-clinical-study-for-those-with-sciatica-or-leg-pain-from-a-herniated-disc-is-now-enrolling-300872966.html
SOURCE The Discovery Study