SI-6603 Versus Placebo in Patients With Lumbar Disc Herniation
- Registration Number
- NCT00634946
- Lead Sponsor
- Seikagaku Corporation
- Brief Summary
The purpose of this study is to determine whether SI-6603 is effective in the treatment of lumbar disc herniation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 195
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description III SI-6603 - I SI-6603 - IV Placebo - II SI-6603 -
- Primary Outcome Measures
Name Time Method Changes in leg pain from baseline. 13 weeks
- Secondary Outcome Measures
Name Time Method The leg pain At each assessment time point
Trial Locations
- Locations (8)
Chubu Area
🇯🇵Chubu, Japan
Kansai Area
🇯🇵Kansai, Japan
Chugoku Area
🇯🇵Chugoku, Japan
Kanto Area
🇯🇵Kanto, Japan
Kyushu Area
🇯🇵Kyushu, Japan
Hokkaido Area
🇯🇵Hokkaido, Japan
Shikoku Area
🇯🇵Shikoku, Japan
Tohoku Area
🇯🇵Tohoku, Japan