The purpose of this study is to evaluate the efficacy and safety of SI-6603 (condoliase) in patients with lumbar disc herniation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
385
1.25U, intradiscal injection, one time
Unnamed facility
Phoenix, Arizona, United States
Leg pain
Assessed by Visual Analog Scale (VAS)
Time frame: 13 weeks
Responder rate evaluation
Assessed by leg pain (VAS), Oswestry Disability Index disability questionnaire, neurologic status (motor, sensory, reflexes), and no treatment failure
Time frame: 13 weeks
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Unnamed facility
Gold River, California, United States
Unnamed facility
Laguna Hills, California, United States
Unnamed facility
Los Gatos, California, United States
Unnamed facility
Murrieta, California, United States
Unnamed facility
Riverside, California, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Hialeah, Florida, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Merritt Island, Florida, United States
...and 22 more locations