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

Lumbar Vertebra Hernia Clinical Trial

Official title:

An Open Label, Non-randomized Dose-escalation Study to Assess Safety and Tolerability of SI-6603 in Patients With Lumbar Disc Herniation (Phase II Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01282606
• Other study ID #: 6603/1121
• Status: Completed
• Phase: Phase 2
• Start date: December 2007

Study information

• Verified date: March 2023
• Source: Seikagaku Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Lumbar Vertebra Hernia

Intervention

Drug:
• SI-6603
SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.

Locations

Country	Name	City	State
United States	SKK	Encinitas	California

Sponsors (1)

Lead Sponsor	Collaborator
Seikagaku Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		52 weeks
Secondary	The leg pain		At each assessment time point