SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study)

Seikagaku

Status and phase: Completed; Phase 3

Conditions: Lumbar Disc Herniation

Treatments: Drug: Sham injection; Drug: SI-6603

Study type: Interventional

Funder types: Industry

Identifiers

NCT03607838

6603 /1133

Details and patient eligibility

About

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

Enrollment: 352 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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352 participants in 2 patient groups

SI-6603

Experimental group

Description:

Condoliase: 1.25U, intradiscal injection, one time For patients in the active treatment group, a volume of 1.0 mL was administered into the intervertebral disc in a single dose.

Treatment:

Drug: SI-6603

Sham

Sham Comparator group

Description:

Sham injection For patients in the control group, a solution was not prepared and the needle was not placed in the intervertebral disc.

Treatment:

Drug: Sham injection