Back to resultsClinical Trial to Assess Safety of SI-6603 in Patients With Lumbar Disc Herniation
Primary Purpose
Lumbar Vertebra Hernia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SI-6603
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Vertebra Hernia focused on measuring Chemonucleolysis, Lumbar Vertebrae, Hernia
Eligibility 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.
Sites / Locations
- SKK
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Drug I: SI-6603 (Low)
Drug II: SI-6603 (Middle)
Drug III: SI-6603 (High)
Arm Description
Outcomes
Primary Outcome Measures
Adverse events
Secondary Outcome Measures
The leg pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01282606
Brief Title
Clinical Trial to Assess Safety of SI-6603 in Patients With Lumbar Disc Herniation
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seikagaku Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety of SI-6603 in lumbar disc herniation patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Vertebra Hernia
Keywords
Chemonucleolysis, Lumbar Vertebrae, Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug I: SI-6603 (Low)
Arm Type
Experimental
Arm Title
Drug II: SI-6603 (Middle)
Arm Type
Experimental
Arm Title
Drug III: SI-6603 (High)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SI-6603
Intervention Description
SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
Primary Outcome Measure Information:
Title
Adverse events
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
The leg pain
Time Frame
At each assessment time point
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
SKK
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial to Assess Safety of SI-6603 in Patients With Lumbar Disc Herniation
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