Overview
The goal of this study is to determine the effectiveness of a single-dose injection of SI-6603 in patients with lumbar disc herniation (LDH). Patients will either receive an injection of SI-6603 in their intervertebral disc, or a sham injection as a placebo, performed without needle placement.
Study Information
320 subjects will be enrolled in the study. The primary purpose of the trial is treatment. The study began on May 30, 2018 and is estimated to be completed by November 2022.
Inclusion Criteria
- Subjects with single-level LDH (L4-L5 or L5-S1 (or L5-L6)) with clear, demonstrable nerve root impingement as assessed by magnetic resonance imaging (MRI) and clinical symptoms corresponding to position of the impaired nerve root.
- Subjects with radiculopathy/radicular leg pain in the unilateral leg for 6 weeks or more but 1 year or less.
- Subjects with positive result of Straight Leg Raise (SLR) test (≤70°) only on the ipsilateral leg having chief complaint of radiculopathy
- Subjects with inadequate improvement in pain caused by LDH despite 6 weeks or more of conservative treatment.
Exclusion Criteria
- Subjects who have 2 or more lumbar disc herniations as assessed by MRI.
- Subjects who have undergone a lumbar operation, lumbar percutaneous nucleotomy, or lumbar intradiscal therapies at the affected level of lumbar spine.
- Subjects who have received block procedure (e.g., spinal injection, epidural injection or nerve block) for treatment of LDH, oral or injectable corticosteroids within 28 days prior to randomization.
- Subjects who have received opioids or cannabis by any route of administration, local anesthesia to the back, buttock, or posterior/lateral aspects of the affected leg within 7 days prior to randomization.
- Subjects with a body mass index (BMI) ≥40.
- Subjects who are receiving compensation according to the Workers’ Compensation Act or are involved in personal injury litigation due to a lumbar-related injury.
Location
This study will take place at numerous locations including California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Michigan, New Hampshire, Pennsylvania, South Carolina, Utah, Virginia, and West Virginia.
Sponsors / Collaborators
This study is sponsored by the Seikagaku Corporation.
