Intervertebral Disc Disease, Lumbar Disc Disease
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of SI-6603 (condoliase) in patients with lumbar disc herniation.
Interventions
DRUGCondoliase
1.25U, intradiscal injection, one time
DRUGplacebo
Sponsors
Seikagaku Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
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 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 received spinal injection, epidural injection, nerve block within 3 weeks prior to the time of informed consent. * Patients who have undergone lumbar operation, or lumbar percutaneous nucleotomy or lumbar intradiscal therapies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leg pain | 13 weeks | Assessed by Visual Analog Scale (VAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responder rate evaluation | 13 weeks | Assessed by leg pain (VAS), Oswestry Disability Index disability questionnaire, neurologic status (motor, sensory, reflexes), and no treatment failure |
Countries
United States
Outcome results
None listed