A Study of SI-6603 in Patients With Lumbar Disc Herniation

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of SI-6603(Condoliase) in patients with lumbar disc herniation.

Official Title
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A Multicenter, Open-label Study of SI 6603 in Patients With Lumbar Disc Herniation (Phase III)

Conditions
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Intervertebral Disc Disease, Lumbar Disc Disease

Intervention / Treatment
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* Drug: Condoliase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with lumbar disc herniation (L1-L2, L2-L3, L3-L4, L4-L5 or L5-S1) as assessed by MRI and clinical symptoms corresponding to position of the impaired nerve root. 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 who have 2 or more lumbar disc herniations as assessed by MRI. 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SI-6603<br>SI-6603: SI-6603 is administrated into the nucleus pulposus of the intervertebral disc | Drug: Condoliase<br>* 1.25 U, intradiscal injection, one time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Emergent Adverse Events (TEAE) | A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that began or that worsened in severity after the investigational drug had been administered. All AEs, including intercurrent illnesses and regardless of the relationship to investigational drug, occurring during the study were documented from the signing of the informed consent form until completion of final visit. Concomitant illnesses, which existed before entry into the study, were not considered AEs unless they worsened during the treatment period. All AEs, regardless of the source of identification (e.g., physical examination, laboratory assessment, or reported by patient), had to be documented. | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worst Leg Pain as Assessed by Visual Analog Scale (VAS) | Worst leg pain intensity during the past 24 hours assessed by Visual Analog Scale (VAS). Scores are recorded by making a handwritten mark on a 100 mm line that represents a continuum between no pain (0 mm) and extreme pain (100 mm). | 26 weeks |