Back to resultsA Study of SI-6603 in Patients With Lumbar Disc Herniation
Primary Purpose
Intervertebral Disc Disease, Lumbar Disc Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Condoliase
Sponsored by
About this trial
This is an interventional treatment trial for Intervertebral Disc Disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SI-6603
Arm Description
SI-6603: SI-6603 is administrated into the nucleus pulposus of the intervertebral disc
Outcomes
Primary Outcome Measures
Number of Participants With Treatment-Emergent Adverse Events (TEAE)
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.
Secondary Outcome Measures
Worst Leg Pain as Assessed by Visual Analog Scale (VAS)
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02421601
Brief Title
A Study of SI-6603 in Patients With Lumbar Disc Herniation
Official Title
A Multicenter, Open-label Study of SI 6603 in Patients With Lumbar Disc Herniation (Phase III)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seikagaku Corporation
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy 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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1011 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SI-6603
Arm Type
Experimental
Arm Description
SI-6603: SI-6603 is administrated into the nucleus pulposus of the intervertebral disc
Intervention Type
Drug
Intervention Name(s)
Condoliase
Intervention Description
1.25 U, intradiscal injection, one time
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Description
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.
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Worst Leg Pain as Assessed by Visual Analog Scale (VAS)
Description
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).
Time Frame
26 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 (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
Facility Information:
City
Mobile
State/Province
Alabama
Country
United States
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
Riverside
State/Province
California
Country
United States
City
Temecula
State/Province
California
Country
United States
City
Greenwood Village
State/Province
Colorado
Country
United States
City
Clermont
State/Province
Florida
Country
United States
City
Hialeah
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Miami Gardens
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Naples
State/Province
Florida
Country
United States
City
Pinellas Park
State/Province
Florida
Country
United States
City
Saint Petersburg
State/Province
Florida
Country
United States
City
Sarasota
State/Province
Florida
Country
United States
City
South Miami
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
Charleston
State/Province
South Carolina
Country
United States
City
Plano
State/Province
Texas
Country
United States
City
Sandy
State/Province
Utah
Country
United States
City
Eichstätt
State/Province
Bayern
Country
Germany
City
Frankfurt
State/Province
Hessen
Country
Germany
City
Köln
State/Province
Nordrhein-Westfalen
Country
Germany
City
Göppingen
State/Province
Stuttgart
Country
Germany
City
Berlin
Country
Germany
City
Hamburg
Country
Germany
City
Brasov
Country
Romania
City
Bucuresti
Country
Romania
City
Sibiu
Country
Romania
City
Cadiz
State/Province
Andalucía
Country
Spain
City
Palma de Mallorca
State/Province
Baleares
Country
Spain
City
Badalona
State/Province
Barcelona
Country
Spain
City
Terrassa
State/Province
Barcelona
Country
Spain
City
Valladolid
State/Province
Castilla Y León
Country
Spain
City
Alcorcón
State/Province
Madrid
Country
Spain
City
Barcelona
Country
Spain
City
Ourense
Country
Spain
City
Valencia
Country
Spain
12. IPD Sharing Statement
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A Study of SI-6603 in Patients With Lumbar Disc Herniation
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