A Study of SI-6603 in Patients With Lumbar Disc Herniation
NCT ID: NCT02421601
Last Updated: 2023-03-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1011 participants
INTERVENTIONAL
2015-03-31
2018-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SI-6603
SI-6603: SI-6603 is administrated into the nucleus pulposus of the intervertebral disc
Condoliase
1.25 U, intradiscal injection, one time
Interventions
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Condoliase
1.25 U, intradiscal injection, one time
Eligibility Criteria
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Inclusion Criteria
* 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 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
30 Years
70 Years
ALL
No
Sponsors
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Seikagaku Corporation
INDUSTRY
Responsible Party
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Locations
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Mobile, Alabama, United States
Phoenix, Arizona, United States
Gold River, California, United States
Laguna Hills, California, United States
Los Gatos, California, United States
Riverside, California, United States
Temecula, California, United States
Greenwood Village, Colorado, United States
Clermont, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Miami Gardens, Florida, United States
Naples, Florida, United States
Pinellas Park, Florida, United States
Sarasota, Florida, United States
South Miami, Florida, United States
St. Petersburg, Florida, United States
Winter Park, Florida, United States
Marietta, Georgia, United States
Newnan, Georgia, United States
Bloomington, Illinois, United States
Carmel, Indiana, United States
Shreveport, Louisiana, United States
City of Saint Peters, Missouri, United States
Hartsdale, New York, United States
Eugene, Oregon, United States
Charleston, South Carolina, United States
Plano, Texas, United States
Sandy City, Utah, United States
Eichstätt, Bavaria, Germany
Frankfurt am Main, Hesse, Germany
Cologne, North Rhine-Westphalia, Germany
Göppingen, Stuttgart, Germany
Berlin, , Germany
Hamburg, , Germany
Brasov, , Romania
Bucharest, , Romania
Sibiu, , Romania
Cadiz, Andalusia, Spain
Palma de Mallorca, Balearic Islands, Spain
Badalona, Barcelona, Spain
Terrassa, Barcelona, Spain
Valladolid, Castille and León, Spain
Alcorcón, Madrid, Spain
Barcelona, , Spain
Ourense, , Spain
Valencia, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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6603/1132
Identifier Type: -
Identifier Source: org_study_id
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