A Study of SI-6603 in Patients With Lumbar Disc Herniation
NCT ID: NCT01941563
Last Updated: 2023-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
385 participants
INTERVENTIONAL
2013-09-30
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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SI-6603
SI-6603 is administrated into the nucleus pulposus of the intervertebral disc
Condoliase
1.25U, intradiscal injection, one time
Control
Sham injection
placebo
Interventions
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Condoliase
1.25U, intradiscal injection, one time
placebo
Eligibility Criteria
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Inclusion Criteria
* Patients assessed as positive in the 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 received spinal injection, epidural injection, nerve block within 3 weeks prior to the time of informed consent.
* 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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Phoenix, Arizona, United States
Gold River, California, United States
Laguna Hills, California, United States
Los Gatos, California, United States
Murrieta, California, United States
Riverside, California, United States
Denver, Colorado, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Merritt Island, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
North Miami Beach, Florida, United States
Orlando, Florida, United States
Pinellas Park, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
Sunrise, 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
State College, Pennsylvania, United States
Charleston, South Carolina, United States
Dallas, Texas, United States
Sandy City, Utah, United States
Edmonds, Washington, United States
Countries
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Other Identifiers
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6603/1131
Identifier Type: -
Identifier Source: secondary_id
6603/1131
Identifier Type: -
Identifier Source: org_study_id
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