A Study of SI-6603 in Patients With Lumbar Disc Herniation

March 21, 2023 updated by: Seikagaku Corporation

A Multicenter, Open-label Study of SI 6603 in Patients With Lumbar Disc Herniation (Phase III)

The purpose of this study is to evaluate the safety and efficacy of SI-6603(Condoliase) in patients with lumbar disc herniation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1011

Phase

  • Phase 3

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

  • Germany
      • Berlin, Germany
      • Hamburg, Germany
    • Bayern
      • Eichstätt, Bayern, Germany
    • Hessen
      • Frankfurt, Hessen, Germany
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany
    • Stuttgart
      • Göppingen, Stuttgart, Germany
  • Romania
      • Brasov, Romania
      • Bucuresti, Romania
      • Sibiu, Romania
  • Spain
      • Barcelona, Spain
      • Ourense, Spain
      • Valencia, Spain
    • Andalucía
      • Cadiz, Andalucía, Spain
    • Baleares
      • Palma de Mallorca, Baleares, Spain
    • Barcelona
      • Badalona, Barcelona, Spain
      • Terrassa, Barcelona, Spain
    • Castilla Y León
      • Valladolid, Castilla Y León, Spain
    • Madrid
      • Alcorcón, Madrid, Spain
  • United States
    • Alabama
      • Mobile, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • Gold River, California, United States
      • Laguna Hills, California, United States
      • Los Gatos, California, United States
      • Riverside, California, United States
      • Temecula, California, United States
    • Colorado
      • Greenwood Village, Colorado, United States
    • Florida
      • Clermont, Florida, United States
      • Hialeah, Florida, United States
      • Jacksonville, Florida, United States
      • Miami, Florida, United States
      • Miami Gardens, Florida, United States
      • Naples, Florida, United States
      • Pinellas Park, Florida, United States
      • Saint Petersburg, Florida, United States
      • Sarasota, Florida, United States
      • South Miami, Florida, United States
      • Winter Park, Florida, United States
    • Georgia
      • Marietta, Georgia, United States
      • Newnan, Georgia, United States
    • Illinois
      • Bloomington, Illinois, United States
    • Indiana
      • Carmel, Indiana, United States
    • Louisiana
      • Shreveport, Louisiana, United States
    • Missouri
      • Saint Peters, Missouri, United States
    • New York
      • Hartsdale, New York, United States
    • Oregon
      • Eugene, Oregon, United States
    • South Carolina
      • Charleston, South Carolina, United States
    • Texas
      • Plano, Texas, United States
    • Utah
      • Sandy, Utah, United States

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 (L1-L2, L2-L3, L3-L4, 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 Femoral Nerve Stretching (FNS) test for L1-L2, L2-L3, or L3-L4 and Straight Leg Raising (SLR) test.
  • Patients with sciatica in either leg.
  • Patients with no improvement from conservative treatment

Exclusion Criteria:

  • Patients who have 2 or more lumbar disc herniations as assessed by MRI.
  • Patients in whom a rupture into the posterior longitudinal ligament is identified by MRI.
  • Patients who have undergone lumbar operation, or lumbar percutaneous nucleotomy or lumbar intradiscal therapies

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SI-6603
SI-6603: SI-6603 is administrated into the nucleus pulposus of the intervertebral disc
Drug: Condoliase
1.25 U, intradiscal injection, one time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Time Frame: 26 weeks
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that began or that worsened in severity after the investigational drug had been administered. All AEs, including intercurrent illnesses and regardless of the relationship to investigational drug, occurring during the study were documented from the signing of the informed consent form until completion of final visit. Concomitant illnesses, which existed before entry into the study, were not considered AEs unless they worsened during the treatment period. All AEs, regardless of the source of identification (e.g., physical examination, laboratory assessment, or reported by patient), had to be documented.
26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Worst Leg Pain as Assessed by Visual Analog Scale (VAS)
Time Frame: 26 weeks
Worst leg pain intensity during the past 24 hours assessed by Visual Analog Scale (VAS). Scores are recorded by making a handwritten mark on a 100 mm line that represents a continuum between "no pain" (0 mm) and "extreme pain" (100 mm).
26 weeks

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

March 1, 2015

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

April 6, 2015

First Submitted That Met QC Criteria

April 17, 2015

First Posted (Estimate)

April 20, 2015

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6603/1132

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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