A Study of SI-6603 in Patients With Lumbar Disc Herniation
Status: | Completed |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 30 - 70 |
Updated: | 8/12/2018 |
Start Date: | September 2013 |
End Date: | August 2017 |
The purpose of this study is to evaluate the efficacy and safety of SI-6603 (condoliase) in
patients with lumbar disc herniation.
patients with lumbar disc herniation.
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
We found this trial at
33
sites
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