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

February 27, 2008
March 29, 2011
January 2008
November 2009   (final data collection date for primary outcome measure)
Changes in leg pain from baseline. [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00634946 on ClinicalTrials.gov Archive Site
The leg pain [ Time Frame: At each assessment time point ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
SI-6603 Versus Placebo in Patients With Lumbar Disc Herniation
A Multicenter, Randomized, Double-blind Recommended Dose-finding Study of SI-6603 in Patients With Lumbar Disc Herniation (Phase II/III Study)

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

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Lumbar Vertebra Hernia
  • Drug: SI-6603
    SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
  • Drug: Placebo
    Placebo is administrated into the nucleus pulposus of an intervertebral disc.
  • Experimental: I
    Intervention: Drug: SI-6603
  • Experimental: II
    Intervention: Drug: SI-6603
  • Experimental: III
    Intervention: Drug: SI-6603
  • Placebo Comparator: IV
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
195
August 2010
November 2009   (final data collection date for primary outcome measure)

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
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00634946
6603/1021, 6603/1021
Not Provided
Takao Murayama, Clinical Development Dept., Research & Development Div.
Seikagaku Corporation
Not Provided
Not Provided
Seikagaku Corporation
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP