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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seikagaku Corporation
ClinicalTrials.gov Identifier:
NCT01282606
First received: January 24, 2011
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Lumbar Vertebra Hernia
Drug: SI-6603
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Seikagaku Corporation:

Primary Outcome Measures:
  • Adverse events [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The leg pain [ Time Frame: At each assessment time point ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: December 2007
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug I: SI-6603 (Low) Drug: SI-6603
SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
Experimental: Drug II: SI-6603 (Middle) Drug: SI-6603
SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
Experimental: Drug III: SI-6603 (High) Drug: SI-6603
SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282606

Locations
United States, California
SKK
Encinitas, California, United States, 92024
Sponsors and Collaborators
Seikagaku Corporation
  More Information

No publications provided

Responsible Party: Seikagaku Corporation
ClinicalTrials.gov Identifier: NCT01282606     History of Changes
Other Study ID Numbers: 6603/1121
Study First Received: January 24, 2011
Last Updated: September 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Seikagaku Corporation:
Chemonucleolysis
Lumbar Vertebrae
Hernia

Additional relevant MeSH terms:
Hernia
Intervertebral Disk Displacement
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 17, 2014