Clinical Trial to Assess Safety of SI-6603 in Patients With Lumbar Disc Herniation

Phase 2

Completed

• Conditions: Lumbar Vertebra Hernia
• Interventions: Drug: SI-6603

• Registration Number: NCT01282606
• Lead Sponsor: Seikagaku Corporation

Brief Summary

The purpose of this study is to evaluate the safety of SI-6603 in lumbar disc herniation patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-01-24
• Study First Posted: 2011-01-25
• Disposition First Submitted: 2012-07-12
• Disposition First Submitted QC: 2012-07-25
• Primary Completion: 2012-08
• Disposition First Posted: 2012-08-02
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 lower leg.
• Patients with no improvement from pharmacotherapy or concomitant treatment with drug and nerve block.

Exclusion Criteria

• Patients who have 2 or more lumbar disc herniations as assessed by MRI.
• Patients with "extrusion-type" or "sequestration-type" herniation in whom a rupture into the posterior longitudinal ligament is identified by MRI.
• Patients who have received nerve block within 3 weeks before screening.
• Patients who have undergone lumbar operation, chemonucleolysis, or percutaneous nucleotomy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drug I: SI-6603 (Low)	SI-6603	-
Drug II: SI-6603 (Middle)	SI-6603	-
Drug III: SI-6603 (High)	SI-6603	-

Primary Outcome Measures

Name	Time	Method
Adverse events	52 weeks

Secondary Outcome Measures

Name	Time	Method
The leg pain	At each assessment time point

Trial Locations

Locations (1)

SKK; 🇺🇸 Encinitas, California, United States