SI-6603 Versus Placebo in Patients With Lumbar Disc Herniation

A Multicenter, Randomized, Double-blind Recommended Dose-finding Study of SI-6603 in Patients With Lumbar Disc Herniation (Phase II/III Study)

The purpose of this study is to determine whether SI-6603 is effective in the treatment of lumbar disc herniation.

Inclusion Criteria:

• Patients with lumbar disc herniation (L4-L5 or L5-S1) as assessed by MRI and clinical symptoms corresponding to position of the impaired nerve root
• Patients assessed as positive in the SLR test
• Patients with sciatica in either lower leg
• Patients with no improvement from pharmacotherapy or concomitant treatment with drug and nerve block

Exclusion Criteria:

• Patients who have 2 or more lumbar disc herniations as assessed by MRI
• Patients with "extrusion-type" or "sequestration-type" herniation in whom a rupture into the posterior longitudinal ligament is identified by MRI
• Patients who have received nerve block within 3 weeks before screening
• Patients who have undergone lumbar operation, chemonucleolysis, or percutaneous nucleotomy