Status:
COMPLETED
SI-6603 Versus Placebo in Patients With Lumbar Disc Herniation
Lead Sponsor:
Seikagaku Corporation
Conditions:
Lumbar Vertebra Hernia
Eligibility:
All Genders
20-70 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine whether SI-6603 is effective in the treatment of lumbar disc herniation.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT00634946
Start Date
January 1 2008
End Date
August 1 2010
Last Update
March 23 2023
Active Locations (8)
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1
Chugoku Area
Chugoku, Japan
2
Chubu Area
Chūbu, Japan
3
Hokkaido Area
Hokkaido, Japan
4
Kansai Area
Kansai, Japan