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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01282606
First Posted: January 25, 2011
Last Update Posted: September 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Seikagaku Corporation
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • The leg pain [ Time Frame: At each assessment time point ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01282606


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

Responsible Party: Seikagaku Corporation
ClinicalTrials.gov Identifier: NCT01282606     History of Changes
Other Study ID Numbers: 6603/1121
First Submitted: January 24, 2011
First Posted: January 25, 2011
Last Update Posted: September 16, 2013
Last Verified: September 2013

Keywords provided by Seikagaku Corporation:
Chemonucleolysis
Lumbar Vertebrae
Hernia

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical