Trial | NCT01282606  Report issue

Title

Clinical Trial to Assess Safety of SI-6603 in Patients With Lumbar Disc Herniation
An Open Label, Non-randomized Dose-escalation Study to Assess Safety and Tolerability of SI-6603 in Patients With Lumbar Disc Herniation (Phase II Study)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    18
The purpose of this study is to evaluate the safety of SI-6603 in lumbar disc herniation patients.
Study Started
Dec 31
2007
Primary Completion
Aug 31
2012
Last Update
Mar 23
2023

Drug SI-6603

SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.

Drug I: SI-6603 (Low) Experimental

Drug II: SI-6603 (Middle) Experimental

Drug III: SI-6603 (High) Experimental

Criteria 

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.
No Results Posted