SI-6603 Versus Placebo in Patients With Lumbar Disc Herniation

Seikagaku

Status and phase: Completed; Phase 3; Phase 2

Conditions: Lumbar Vertebra Hernia

Treatments: Drug: Placebo; Drug: SI-6603

Study type: Interventional

Funder types: Industry

Identifiers

NCT00634946

6603/1021

Details and patient eligibility

About

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

Enrollment: 195 patients

Sex: All

Ages: 20 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: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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195 participants in 4 patient groups, including a placebo group

I

Experimental group

Treatment:

Drug: SI-6603

II

Experimental group

Treatment:

Drug: SI-6603

III

Experimental group

Treatment:

Drug: SI-6603

IV

Placebo Comparator group

Treatment:

Drug: Placebo