SI-6603 Versus Placebo in Patients With Lumbar Disc Herniation - Full Text View

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 II Phase III

MedlinePlus related topics:

Hernia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Multicenter, Randomized, Double-Blind Recommended Dose-Finding Study of SI-6603 in Patients With Lumbar Disc Herniation (Phase II/III Study)

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 ]

Estimated Enrollment:	184
Study Start Date:	January 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental	Drug: SI-6603 SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
II: Experimental	Drug: SI-6603 SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
III: Experimental	Drug: SI-6603 SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
IV: Placebo Comparator	Drug: Placebo Placebo is administrated into the nucleus pulposus of an intervertebral disc.

Eligibility

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

Contacts


Contact: Takao Murayama		takao.murayama@seikagaku.co.jp

Locations

Sponsors and Collaborators

Seikagaku Corporation

More Information

Responsible Party:	Clinical Development Dept., Research & Development Div. ( Takao Murayama )
Study ID Numbers:	6603/1021, 6603/1021
First Received:	February 27, 2008
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00634946
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Seikagaku Corporation:

Chemonucleolysis

Lumbar Vertebrae

Hernia

Study placed in the following topic categories:

Pathological Conditions, Anatomical

Signs and Symptoms

Hernia

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Seikagaku Corporation
Information provided by:	Seikagaku Corporation
ClinicalTrials.gov Identifier:	NCT00634946