TITLE – A STUDY TO EVALUATE THE LONG TERM SAFETY OF A MEDICATION CALLED SI-6603 FOR PATIENTS WITH A LUMBAR DISC HERNIATION
Chronic Pain for patients with lumbar disc herniation (a rupture or protrusion of the disc between the bones of the spine)
The purpose of this study is to evaluate how well the drug works and long-term safety of a medication called SI-6603 in patients with a lumbar disc herniation by monitoring the patients for 1 year after the administration of a single dose of the medication.
Patients will receive either an injection of the study drug into the herniated disc or a placebo (a product that has no active part)
Information regarding safety and side effects that may occur will also be collected.
METHOD OF ADMINISTRATION:
Single injection of study medication
Cherian Sajan, MD
KEY REQUIREMENTS TO QUALIFY FOR THIS STUDY:
- Must be between 30 and 70 years of age
- Must have been diagnosed with lumbar disc herniation
- Must have pain in only one leg:
- Must have received 6 weeks or more of adequate conservative medication treatment without any improvement of your pain
Each subject will be asked to visit the clinic on 10 to 11 days over the period of a year. Most visits will take approximately 1 to 3 hours, but the visit when you receive the experimental study treatment may take a full day.
1693 Lee Road Winter Park, Fl. 32789
Qualified participants may receive up to $500 for time and travel
WHOM TO CONTACT:
Recruitment Department: 407-203-7936