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

March 21, 2023 updated by: Seikagaku Corporation

An Open Label, Non-randomized Dose-escalation Study to Assess Safety and Tolerability of SI-6603 in Patients With Lumbar Disc Herniation (Phase II Study)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Encinitas, California, United States, 92024
        • SKK

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug I: SI-6603 (Low)
Drug: SI-6603
SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
Experimental: Drug II: SI-6603 (Middle)
Drug: SI-6603
SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
Experimental: Drug III: SI-6603 (High)
Drug: SI-6603
SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The leg pain
Time Frame: At each assessment time point
At each assessment time point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seikagaku Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

January 24, 2011

First Submitted That Met QC Criteria

January 24, 2011

First Posted (Estimate)

January 25, 2011

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6603/1121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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