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

Seikagaku

Status and phase: Completed; Phase 3

Conditions: Lumbar Disc Disease; Intervertebral Disc Disease

Treatments: Drug: Condoliase

Study type: Interventional

Funder types: Industry

Identifiers

NCT02421601

6603/1132

Details and patient eligibility

About

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

Enrollment: 1,011 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,011 participants in 1 patient group

SI-6603

Experimental group

Description:

SI-6603: SI-6603 is administrated into the nucleus pulposus of the intervertebral disc

Treatment:

Drug: Condoliase