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

Seikagaku

Status and phase: Completed; Phase 3

Conditions: Intervertebral Disc Disease; Lumbar Disc Disease

Treatments: Drug: Condoliase; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01941563

6603/1131

Details and patient eligibility

About

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

Enrollment: 385 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with lumbar disc herniation (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 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 received spinal injection, epidural injection, nerve block within 3 weeks prior to the time of informed consent.
• Patients who have undergone lumbar operation, or lumbar percutaneous nucleotomy or lumbar intradiscal therapies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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385 participants in 2 patient groups

SI-6603

Experimental group

Description:

SI-6603 is administrated into the nucleus pulposus of the intervertebral disc

Treatment:

Drug: Condoliase

Control

Sham Comparator group

Description:

Sham injection

Treatment:

Drug: placebo