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SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study)

Primary Purpose

Lumbar Disc Herniation

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SI-6603
Sham injection
Sponsored by
Seikagaku Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring Lumbar disc herniation, Radiculopathy, Sciatica, Intradiscal injection, Chemonucleolysis

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects with single-level LDH (L4-L5 or L5-S1 (or L5-L6)) with clear, demonstrable nerve root impingement as assessed by magnetic resonance imaging (MRI) and clinical symptoms corresponding to position of the impaired nerve root.
  • Subjects with radiculopathy/radicular leg pain in the unilateral leg for 6 weeks or more but 1 year or less.
  • Subjects with positive result of Straight Leg Raise (SLR) test (≤70°) only on the ipsilateral leg having chief complaint of radiculopathy
  • Subjects with inadequate improvement in pain caused by LDH despite 6 weeks or more of conservative treatment.

Exclusion Criteria:

  • Subjects who have 2 or more lumbar disc herniations as assessed by MRI.
  • Subjects who have undergone a lumbar operation, lumbar percutaneous nucleotomy, or lumbar intradiscal therapies at the affected level of lumbar spine.
  • Subjects who have received block procedure (e.g., spinal injection, epidural injection or nerve block) for treatment of LDH, oral or injectable corticosteroids within 28 days prior to randomization.
  • Subjects who have received opioids or cannabis by any route of administration, local anesthesia to the back, buttock, or posterior/lateral aspects of the affected leg within 7 days prior to randomization.
  • Subjects with a body mass index (BMI) ≥40.
  • Subjects who are receiving compensation according to the Workers' Compensation Act or are involved in personal injury litigation due to a lumbar-related injury.

Sites / Locations

  • Delta Clinical Research
  • Pain Medicine Associates, Inc.
  • University of California San Diego - Center for Pain Medicine
  • The Helm Center for Pain Management
  • The Anand Spine Group
  • VA Greater Los Angeles Healthcare System
  • Samaritan Center for Medical Research
  • UC Davis Spine Center
  • Source Healthcare
  • Boulder Neurosurgical Associates
  • DBPS Research, LLC
  • International Spine, Pain, and Performance Center
  • Florida Spine Institute
  • Spine and Orthopedic Center
  • Deland Clinical research Unit
  • Science Connections, LLC
  • Coastal Clinical Research
  • Holy Cross Medical Group
  • Coastal Clinical Research
  • AMPM Research Clinic
  • Genoma Research Group, Inc.
  • Science Connections, LLC (Kendall)
  • Pain Relief Centers
  • Pain Relief Centers
  • Tampa Pain Relief Center
  • Florida Pain Relief Group, PLLC
  • Premier Medical Associates
  • Conquest Research
  • Augusta University - Medical College of Georgia
  • Georgia Institute for Clinical Research, LLC
  • Injury Care Research
  • Millennium Pain Center
  • Chicago Anesthesia Pain Specialists
  • Indiana Spine Group
  • Neuroscience Research Center LLC
  • OtriMed Clinical Research
  • Clinical Trials of Southwest Louisiana, LLC
  • Tulane University School of Medicine
  • St. Louis Pain Consultants
  • Comprehensive and Interventional Pain Management LLP
  • Innovative Pain Care Center
  • Interventional Spine Medicine
  • New Jersey Regenerative Institute
  • New York - Presbyterian Queens
  • Drug Trials America
  • Ainsworth Institute Of Pain Management
  • University of Rochester- Neuromedicine Pain Management Center
  • The Center for Clinical Research
  • Clinical Inquest Center Ltd
  • The Ohio State University Wexner Medical Center
  • META Medical Research Institute
  • Medical Research International
  • Oklahoma City Clinical Research Center
  • Main Line Spine
  • Clinical Trials of South Carolina
  • SC Pain & Spine Specialists
  • Ascension Spine and Scoliosis Center
  • HRMD Research
  • Advanced Medical Trials
  • Interventional Pain Specialists
  • ARH Research, LLC.
  • JBR Clinical Research
  • University of Virginia Orthopaedic Spine Center
  • Virginia iSpine Physicians, P.C.
  • Gershon Pain Specialists
  • Swedish Pain Management
  • West Virginia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

SI-6603

Sham injection

Arm Description

Outcomes

Primary Outcome Measures

Average worst leg pain score during the past 24 hours over the previous 7 days
Assessed by 100 mm Visual Analog Scale (VAS)

Secondary Outcome Measures

Average worst leg pain score during the past 24 hours over the previous 7 days
Assessed by 100 mm Visual Analog Scale (VAS)
Herniation volume assessed by MRI
Oswestry Disability Index (ODI) score

Full Information

First Posted
July 24, 2018
Last Updated
October 20, 2023
Sponsor
Seikagaku Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03607838
Brief Title
SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study)
Official Title
A Multicenter, Randomized, Double-blind, Sham-controlled, Comparative Study of SI-6603 in Subjects With Lumbar Disc Herniation (Phase 3)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
August 18, 2022 (Actual)
Study Completion Date
March 21, 2023 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is to evaluate the effectiveness of a single-dose intervertebral disc injection of SI-6603 in subjects with lumbar disc herniation (LDH)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
Keywords
Lumbar disc herniation, Radiculopathy, Sciatica, Intradiscal injection, Chemonucleolysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
352 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SI-6603
Arm Type
Experimental
Arm Title
Sham injection
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
SI-6603
Intervention Description
SI-6603 will be injected into an intervertebral disc.
Intervention Type
Drug
Intervention Name(s)
Sham injection
Intervention Description
The injection will be performed without needle placement into an intervertebral disc.
Primary Outcome Measure Information:
Title
Average worst leg pain score during the past 24 hours over the previous 7 days
Description
Assessed by 100 mm Visual Analog Scale (VAS)
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Average worst leg pain score during the past 24 hours over the previous 7 days
Description
Assessed by 100 mm Visual Analog Scale (VAS)
Time Frame
52 weeks
Title
Herniation volume assessed by MRI
Time Frame
13 weeks
Title
Oswestry Disability Index (ODI) score
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: Subjects with single-level LDH (L4-L5 or L5-S1 (or L5-L6)) with clear, demonstrable nerve root impingement as assessed by magnetic resonance imaging (MRI) and clinical symptoms corresponding to position of the impaired nerve root. Subjects with radiculopathy/radicular leg pain in the unilateral leg for 6 weeks or more but 1 year or less. Subjects with positive result of Straight Leg Raise (SLR) test (≤70°) only on the ipsilateral leg having chief complaint of radiculopathy Subjects with inadequate improvement in pain caused by LDH despite 6 weeks or more of conservative treatment. Exclusion Criteria: Subjects who have 2 or more lumbar disc herniations as assessed by MRI. Subjects who have undergone a lumbar operation, lumbar percutaneous nucleotomy, or lumbar intradiscal therapies at the affected level of lumbar spine. Subjects who have received block procedure (e.g., spinal injection, epidural injection or nerve block) for treatment of LDH, oral or injectable corticosteroids within 28 days prior to randomization. Subjects who have received opioids or cannabis by any route of administration, local anesthesia to the back, buttock, or posterior/lateral aspects of the affected leg within 7 days prior to randomization. Subjects with a body mass index (BMI) ≥40. Subjects who are receiving compensation according to the Workers' Compensation Act or are involved in personal injury litigation due to a lumbar-related injury.
Facility Information:
Facility Name
Delta Clinical Research
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36609
Country
United States
Facility Name
Pain Medicine Associates, Inc.
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
University of California San Diego - Center for Pain Medicine
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
The Helm Center for Pain Management
City
Laguna Woods
State/Province
California
ZIP/Postal Code
92637
Country
United States
Facility Name
The Anand Spine Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
VA Greater Los Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Samaritan Center for Medical Research
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
UC Davis Spine Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Source Healthcare
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Boulder Neurosurgical Associates
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Facility Name
DBPS Research, LLC
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
International Spine, Pain, and Performance Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20006
Country
United States
Facility Name
Florida Spine Institute
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Spine and Orthopedic Center
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33441
Country
United States
Facility Name
Deland Clinical research Unit
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Science Connections, LLC
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Coastal Clinical Research
City
Fernandina Beach
State/Province
Florida
ZIP/Postal Code
32034
Country
United States
Facility Name
Holy Cross Medical Group
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Coastal Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
AMPM Research Clinic
City
Miami Gardens
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Genoma Research Group, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Science Connections, LLC (Kendall)
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Pain Relief Centers
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Pain Relief Centers
City
Sun City Center
State/Province
Florida
ZIP/Postal Code
33573
Country
United States
Facility Name
Tampa Pain Relief Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Florida Pain Relief Group, PLLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Premier Medical Associates
City
The Villages
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Facility Name
Conquest Research
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Augusta University - Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Georgia Institute for Clinical Research, LLC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Injury Care Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
Country
United States
Facility Name
Millennium Pain Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Facility Name
Chicago Anesthesia Pain Specialists
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Indiana Spine Group
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Neuroscience Research Center LLC
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
OtriMed Clinical Research
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Clinical Trials of Southwest Louisiana, LLC
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Tulane University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
St. Louis Pain Consultants
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Comprehensive and Interventional Pain Management LLP
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Innovative Pain Care Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Interventional Spine Medicine
City
Barrington
State/Province
New Hampshire
ZIP/Postal Code
03825
Country
United States
Facility Name
New Jersey Regenerative Institute
City
Cedar Knolls
State/Province
New Jersey
ZIP/Postal Code
07927
Country
United States
Facility Name
New York - Presbyterian Queens
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Drug Trials America
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
Ainsworth Institute Of Pain Management
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
University of Rochester- Neuromedicine Pain Management Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
The Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Clinical Inquest Center Ltd
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45431
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
META Medical Research Institute
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
Medical Research International
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Oklahoma City Clinical Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73159
Country
United States
Facility Name
Main Line Spine
City
King Of Prussia
State/Province
Pennsylvania
ZIP/Postal Code
19406
Country
United States
Facility Name
Clinical Trials of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
SC Pain & Spine Specialists
City
Murrells Inlet
State/Province
South Carolina
ZIP/Postal Code
29576
Country
United States
Facility Name
Ascension Spine and Scoliosis Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
HRMD Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75240
Country
United States
Facility Name
Advanced Medical Trials
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78628
Country
United States
Facility Name
Interventional Pain Specialists
City
Pasadena
State/Province
Texas
ZIP/Postal Code
77505
Country
United States
Facility Name
ARH Research, LLC.
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77382
Country
United States
Facility Name
JBR Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Virginia Orthopaedic Spine Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Virginia iSpine Physicians, P.C.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Gershon Pain Specialists
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Swedish Pain Management
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Learn more about this trial

SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study)

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