SI-6603 Versus Placebo in Patients With Lumbar Disc Herni... | NCT00634946

Studies
SI-6603 Versus Placebo in Patients With Lumbar Disc Herniation

NCT00634946

Sponsor

Seikagaku Corporation

Status

Completed

Last Update Posted

Mar 23, 2023Actual

Enrollment

195Actual

Phase

Phase 2Phase 3

Conditions

Lumbar Vertebra Hernia

Interventions

SI-6603
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
6603/1021

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Nov 2009Actual

Completion Date

Aug 2010Actual

First Submitted Date

Feb 27, 2008

First Submission Date that Met QC Criteria

Mar 12, 2008

First Posted Date

Mar 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2023

Last Update Posted Date

Mar 23, 2023Actual

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

195Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
I	Experimental	Drug: SI-6603
II	Experimental	Drug: SI-6603
III	Experimental	Drug: SI-6603
IV	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SI-6603	Drug	SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.	I II III

Measure	Description	Time Frame
Changes in leg pain from baseline.		13 weeks

Measure	Description	Time Frame
The leg pain		At each assessment time point

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chugoku Area		Chugoku			Japan
Chubu Area

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29424676	Derived	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.

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms