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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Disc Displacement
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 01, 2014