Lumbar Vertebra Hernia
Conditions
Keywords
Chemonucleolysis, Lumbar Vertebrae, Hernia
Brief summary
The purpose of this study is to determine whether SI-6603 is effective in the treatment of lumbar disc herniation.
Interventions
DRUGSI-6603
SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
DRUGPlacebo
Placebo is administrated into the nucleus pulposus of an intervertebral disc.
Sponsors
Seikagaku Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 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 |
|---|---|
| Changes in leg pain from baseline. | 13 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The leg pain | At each assessment time point |
Countries
Japan
Outcome results
None listed