Clinical Trial to Assess Safety of SI-6603 in Patients With Lumbar Disc Herniation

Seikagaku

Status and phase: Completed; Phase 2

Conditions: Lumbar Vertebra Hernia

Treatments: Drug: SI-6603

Study type: Interventional

Funder types: Industry

Identifiers

NCT01282606

6603/1121

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of SI-6603 in lumbar disc herniation patients.

Enrollment: 18 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Drug I: SI-6603 (Low)

Experimental group

Treatment:

Drug: SI-6603

Drug II: SI-6603 (Middle)

Experimental group

Treatment:

Drug: SI-6603

Drug III: SI-6603 (High)

Experimental group

Treatment:

Drug: SI-6603