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SI-6603 Versus Placebo in Patients With Lumbar Disc Herniation

This study has been completed.
Sponsor:
Information provided by:
Seikagaku Corporation
ClinicalTrials.gov Identifier:
NCT00634946
First received: February 27, 2008
Last updated: March 29, 2011
Last verified: March 2011
History of Changes
  Purpose

The purpose of this study is to determine whether SI-6603 is effective in the treatment of lumbar disc herniation.


Condition Intervention Phase
Lumbar Vertebra Hernia
 Drug: SI-6603
Drug: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind Recommended Dose-finding Study of SI-6603 in Patients With Lumbar Disc Herniation (Phase II/III Study)

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by Seikagaku Corporation:

Primary Outcome Measures:
  • Changes in leg pain from baseline. [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

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

Enrollment: 195
Study Start Date: January 2008
Study Completion Date: August 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I Drug: SI-6603
SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
Experimental: II Drug: SI-6603
SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
Experimental: III Drug: SI-6603
SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
Placebo Comparator: IV Drug: Placebo
Placebo is administrated into the nucleus pulposus of an intervertebral disc.

  Eligibility

Ages Eligible for Study:   20 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: NCT00634946

Locations
Japan
Chubu Area
Chubu, Japan
Chugoku Area
Chugoku, Japan
Hokkaido Area
Hokkaido, Japan
Kansai Area
Kansai, Japan
Kanto Area
Kanto, Japan
Kyushu Area
Kyushu, Japan
Shikoku Area
Shikoku, Japan
Tohoku Area
Tohoku, Japan
Sponsors and Collaborators
Seikagaku Corporation
  More Information

No publications provided

Responsible Party: Takao Murayama, Clinical Development Dept., Research & Development Div.
ClinicalTrials.gov Identifier: NCT00634946     History of Changes
Other Study ID Numbers: 6603/1021, 6603/1021
Study First Received: February 27, 2008
Last Updated: March 29, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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 May 16, 2013