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SI-6603 Versus Placebo in Patients With Lumbar Disc Herniation

Primary Purpose

Lumbar Vertebra Hernia

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
SI-6603
Placebo
Sponsored by
Seikagaku Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Vertebra Hernia focused on measuring Chemonucleolysis, Lumbar Vertebrae, Hernia

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chubu Area
  • Chugoku Area
  • Hokkaido Area
  • Kansai Area
  • Kanto Area
  • Kyushu Area
  • Shikoku Area
  • Tohoku Area

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

I

II

III

IV

Arm Description

Outcomes

Primary Outcome Measures

Changes in leg pain from baseline.

Secondary Outcome Measures

The leg pain

Full Information

First Posted
February 27, 2008
Last Updated
March 21, 2023
Sponsor
Seikagaku Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00634946
Brief Title
SI-6603 Versus Placebo in Patients With Lumbar Disc Herniation
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 Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seikagaku Corporation

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Vertebra Hernia
Keywords
Chemonucleolysis, Lumbar Vertebrae, Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
195 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Title
II
Arm Type
Experimental
Arm Title
III
Arm Type
Experimental
Arm Title
IV
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SI-6603
Intervention Description
SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is administrated into the nucleus pulposus of an intervertebral disc.
Primary Outcome Measure Information:
Title
Changes in leg pain from baseline.
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
The leg pain
Time Frame
At each assessment time point

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Chubu Area
City
Chubu
Country
Japan
Facility Name
Chugoku Area
City
Chugoku
Country
Japan
Facility Name
Hokkaido Area
City
Hokkaido
Country
Japan
Facility Name
Kansai Area
City
Kansai
Country
Japan
Facility Name
Kanto Area
City
Kanto
Country
Japan
Facility Name
Kyushu Area
City
Kyushu
Country
Japan
Facility Name
Shikoku Area
City
Shikoku
Country
Japan
Facility Name
Tohoku Area
City
Tohoku
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
29424676
Citation
Matsuyama Y, Chiba K, Iwata H, Seo T, Toyama Y. A multicenter, randomized, double-blind, dose-finding study of condoliase in patients with lumbar disc herniation. J Neurosurg Spine. 2018 May;28(5):499-511. doi: 10.3171/2017.7.SPINE161327. Epub 2018 Feb 9.
Results Reference
derived

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SI-6603 Versus Placebo in Patients With Lumbar Disc Herniation

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