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

Phase 3

Completed

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

• Registration Number: NCT02421601
• Lead Sponsor: Seikagaku Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-04-06
• Study First Submitted QC: 2015-04-17
• Study First Posted: 2015-04-20
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Disposition First Submitted: 2019-03-20
• Disposition First Submitted QC: 2019-03-20
• Disposition First Posted: 2019-03-27
• Results First Submitted: 2021-08-19
• Results First Submitted QC: 2021-10-14
• Results First Posted: 2021-11-11
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1011

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SI-6603	Condoliase	SI-6603: SI-6603 is administrated into the nucleus pulposus of the intervertebral disc

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (TEAE)	26 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Worst Leg Pain as Assessed by Visual Analog Scale (VAS)	26 weeks	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).