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

Phase 3

Completed

• Conditions: Intervertebral Disc Disease; Lumbar Disc Disease
• Interventions: Drug: Condoliase; Drug: placebo

• Registration Number: NCT01941563
• Lead Sponsor: Seikagaku Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2013-09-12
• Study First Posted: 2013-09-13
• Primary Completion: 2015-11
• Study Completion: 2017-08
• Disposition First Submitted: 2018-08-09
• Disposition First Submitted QC: 2018-08-09
• Disposition First Posted: 2018-08-10
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 385

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SI-6603	Condoliase	SI-6603 is administrated into the nucleus pulposus of the intervertebral disc
Control	placebo	Sham injection

Primary Outcome Measures

Name	Time	Method
Leg pain	13 weeks	Assessed by Visual Analog Scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Responder rate evaluation	13 weeks	Assessed by leg pain (VAS), Oswestry Disability Index disability questionnaire, neurologic status (motor, sensory, reflexes), and no treatment failure