A Study of SI-6603 in Patients With Lumbar Disc Herniation
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 30 - 70 |
Updated: | 3/29/2019 |
Start Date: | March 2015 |
End Date: | February 2018 |
A Multicenter, Open-label Study of SI 6603 in Patients With Lumbar Disc Herniation (Phase III)
The purpose of this study is to evaluate the safety and efficacy of SI-6603(Condoliase) in
patients with lumbar disc herniation.
patients with lumbar disc herniation.
Inclusion Criteria:
- Patients with lumbar disc herniation (L1-L2, L2-L3, L3-L4, 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 Femoral Nerve Stretching (FNS) test for L1-L2,
L2-L3, or L3-L4 and Straight Leg Raising (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 undergone lumbar operation, or lumbar percutaneous nucleotomy or
lumbar intradiscal therapies
We found this trial at
32
sites
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