A Study of SI-6603 in Patients With Lumbar Disc Herniation

• Status: Completed
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of SI-6603(Condoliase) in patients with lumbar disc herniation.

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

Details

• Lead Sponsor: Seikagaku Corporation

Criteria

Inclusion Criteria:

• Patients with lumbar disc herniation (L1-L2, L2-L3, L3-L4, 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 Femoral Nerve Stretching (FNS) test for L1-L2, L2-L3, or L3-L4 and Straight Leg Raising (SLR) test.

• Patients with sciatica in either leg.

• Patients with no improvement from conservative treatment

Exclusion Criteria:

• Patients who have 2 or more lumbar disc herniations as assessed by MRI.

• Patients in whom a rupture into the posterior longitudinal ligament is identified by MRI.

• Patients who have undergone lumbar operation, or lumbar percutaneous nucleotomy or lumbar intradiscal therapies