SI-6603 Versus Placebo in Patients With Lumbar Disc Herniation

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seikagaku Corporation

Criteria

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