Clinical Trial to Assess Safety of SI-6603 in Patients With Lumbar Disc Herniation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Brief Summary

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The purpose of this study is to evaluate the safety of SI-6603 in lumbar disc herniation patients.

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Detailed Description

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Conditions

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Lumbar Vertebra Hernia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drug I: SI-6603 (Low)

Group Type EXPERIMENTAL

SI-6603

Intervention Type DRUG

SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.

Drug II: SI-6603 (Middle)

Group Type EXPERIMENTAL

SI-6603

Intervention Type DRUG

SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.

Drug III: SI-6603 (High)

Group Type EXPERIMENTAL

SI-6603

Intervention Type DRUG

SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.

Interventions

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SI-6603

SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No