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

Primary Purpose

Intervertebral Disc Disease, Lumbar Disc Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Condoliase
placebo
Sponsored by
Seikagaku Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intervertebral Disc Disease

Eligibility Criteria

30 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 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 received spinal injection, epidural injection, nerve block within 3 weeks prior to the time of informed consent.
  • Patients who have undergone lumbar operation, or lumbar percutaneous nucleotomy or lumbar intradiscal therapies

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

SI-6603

Control

Arm Description

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

Sham injection

Outcomes

Primary Outcome Measures

Leg pain
Assessed by Visual Analog Scale (VAS)

Secondary Outcome Measures

Responder rate evaluation
Assessed by leg pain (VAS), Oswestry Disability Index disability questionnaire, neurologic status (motor, sensory, reflexes), and no treatment failure

Full Information

First Posted
September 4, 2013
Last Updated
March 21, 2023
Sponsor
Seikagaku Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01941563
Brief Title
A Study of SI-6603 in Patients With Lumbar Disc Herniation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seikagaku Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intervertebral Disc Disease, Lumbar Disc Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
385 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SI-6603
Arm Type
Experimental
Arm Description
SI-6603 is administrated into the nucleus pulposus of the intervertebral disc
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Sham injection
Intervention Type
Drug
Intervention Name(s)
Condoliase
Intervention Description
1.25U, intradiscal injection, one time
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Leg pain
Description
Assessed by Visual Analog Scale (VAS)
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Responder rate evaluation
Description
Assessed by leg pain (VAS), Oswestry Disability Index disability questionnaire, neurologic status (motor, sensory, reflexes), and no treatment failure
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 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 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 received spinal injection, epidural injection, nerve block within 3 weeks prior to the time of informed consent. Patients who have undergone lumbar operation, or lumbar percutaneous nucleotomy or lumbar intradiscal therapies
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Gold River
State/Province
California
Country
United States
City
Laguna Hills
State/Province
California
Country
United States
City
Los Gatos
State/Province
California
Country
United States
City
Murrieta
State/Province
California
Country
United States
City
Riverside
State/Province
California
Country
United States
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Denver
State/Province
Colorado
Country
United States
City
Hialeah
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
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Merritt Island
State/Province
Florida
Country
United States
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Miami
State/Province
Florida
Country
United States
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Naples
State/Province
Florida
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United States
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North Miami Beach
State/Province
Florida
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United States
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Orlando
State/Province
Florida
Country
United States
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Pinellas Park
State/Province
Florida
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United States
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Saint Petersburg
State/Province
Florida
Country
United States
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Sarasota
State/Province
Florida
Country
United States
City
Sunrise
State/Province
Florida
Country
United States
City
Winter Park
State/Province
Florida
Country
United States
City
Marietta
State/Province
Georgia
Country
United States
City
Newnan
State/Province
Georgia
Country
United States
City
Bloomington
State/Province
Illinois
Country
United States
City
Carmel
State/Province
Indiana
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Saint Peters
State/Province
Missouri
Country
United States
City
Hartsdale
State/Province
New York
Country
United States
City
Eugene
State/Province
Oregon
Country
United States
City
State College
State/Province
Pennsylvania
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Sandy
State/Province
Utah
Country
United States
City
Edmonds
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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