Los Gatos, California 95032

  • Lumbar Disc Herniation


This study is to evaluate the effectiveness of a single-dose intervertebral disc injection of SI-6603 in subjects with lumbar disc herniation (LDH)


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.



Primary Contact:

Kyoichi Osano (for overall study)
Phone: +81-3-5220-8948
Email: reply@seikagaku.co.jp

Backup Contact:

CSSi (for patients)
Phone: 877-770-1411

Location Contact:

Los Gatos, California 95032
United States

There is no listed contact information for this specific location.

Site Status: Recruiting

Data Source: ClinicalTrials.gov

Date Processed: September 26, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.