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SI-6603 Versus Placebo in Patients With Lumbar Disc Herniation

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.
ClinicalTrials.gov Identifier: NCT00634946
Recruitment Status : Completed
First Posted : March 13, 2008
Last Update Posted : March 31, 2011
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Lumbar Vertebra Hernia Drug: SI-6603 Drug: Placebo Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : January 2008
Primary Completion Date : November 2009
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Changes in leg pain from baseline. [ Time Frame: 13 weeks ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 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): 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

Responsible Party: Takao Murayama, Clinical Development Dept., Research & Development Div.
ClinicalTrials.gov Identifier: NCT00634946     History of Changes
Other Study ID Numbers: 6603/1021
First Posted: March 13, 2008    Key Record Dates
Last Update Posted: March 31, 2011
Last Verified: March 2011

Keywords provided by Seikagaku Corporation:
Chemonucleolysis
Lumbar Vertebrae
Hernia

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical