Lumbar Vertebra Hernia
Conditions
Keywords
Chemonucleolysis, Lumbar Vertebrae, Hernia
Brief summary
The purpose of this study is to evaluate the safety of SI-6603 in lumbar disc herniation patients.
Interventions
DRUGSI-6603
SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
Sponsors
Seikagaku Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The leg pain | At each assessment time point |
Countries
United States
Outcome results
None listed