LUMBAR DISC HERNIATION

TITLE – A STUDY TO EVALUATE THE LONG TERM SAFETY OF A MEDICATION CALLED SI-6603 FOR PATIENTS WITH A LUMBAR DISC HERNIATION

CATEGORY:

Chronic Pain for patients with lumbar disc herniation (a rupture or protrusion of the disc between the bones of the spine)

PURPOSE:

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

INVESTIGATOR:

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


LENGTH/DURATION:

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.

LOCATION:

1693 Lee Road Winter Park, Fl. 32789

COMPENSATION:

Qualified participants may receive up to $500 for time and travel

WHOM TO CONTACT:

Recruitment Department: 407-203-7936