SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study)
NCT ID: NCT03607838
Last Updated: 2025-07-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
352 participants
INTERVENTIONAL
2018-11-07
2023-03-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SI-6603
Condoliase: 1.25U, intradiscal injection, one time
For patients in the active treatment group, a volume of 1.0 mL was administered into the intervertebral disc in a single dose.
SI-6603
SI-6603 will be injected into an intervertebral disc.
Sham
Sham injection
For patients in the control group, a solution was not prepared and the needle was not placed in the intervertebral disc.
Sham injection
The injection will be performed without needle placement into an intervertebral disc.
Interventions
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SI-6603
SI-6603 will be injected into an intervertebral disc.
Sham injection
The injection will be performed without needle placement into an intervertebral disc.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
30 Years
70 Years
ALL
No
Sponsors
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Seikagaku Corporation
INDUSTRY
Responsible Party
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Locations
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Delta Clinical Research
Mobile, Alabama, United States
Pain Medicine Associates, Inc.
Fountain Valley, California, United States
University of California San Diego - Center for Pain Medicine
La Jolla, California, United States
The Helm Center for Pain Management
Laguna Woods, California, United States
The Anand Spine Group
Los Angeles, California, United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States
Samaritan Center for Medical Research
Los Gatos, California, United States
UC Davis Spine Center
Sacramento, California, United States
Source Healthcare
Santa Monica, California, United States
Boulder Neurosurgical Associates
Boulder, Colorado, United States
DBPS Research, LLC
Greenwood Village, Colorado, United States
International Spine, Pain, and Performance Center
Washington D.C., District of Columbia, United States
Florida Spine Institute
Clearwater, Florida, United States
Spine and Orthopedic Center
Deerfield Beach, Florida, United States
Deland Clinical research Unit
DeLand, Florida, United States
Science Connections, LLC
Doral, Florida, United States
Coastal Clinical Research
Fernandina Beach, Florida, United States
Holy Cross Medical Group
Fort Lauderdale, Florida, United States
Coastal Clinical Research
Jacksonville, Florida, United States
Genoma Research Group, Inc.
Miami, Florida, United States
Science Connections, LLC (Kendall)
Miami, Florida, United States
AMPM Research Clinic
Miami Gardens, Florida, United States
Pain Relief Centers
St. Petersburg, Florida, United States
Pain Relief Centers
Sun City Center, Florida, United States
Tampa Pain Relief Center
Tampa, Florida, United States
Florida Pain Relief Group, PLLC
Tampa, Florida, United States
Premier Medical Associates
The Villages, Florida, United States
Conquest Research
Winter Park, Florida, United States
Augusta University - Medical College of Georgia
Augusta, Georgia, United States
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, United States
Injury Care Research
Boise, Idaho, United States
Millennium Pain Center
Bloomington, Illinois, United States
Chicago Anesthesia Pain Specialists
Chicago, Illinois, United States
Indiana Spine Group
Carmel, Indiana, United States
Neuroscience Research Center LLC
Overland Park, Kansas, United States
OtriMed Clinical Research
Edgewood, Kentucky, United States
Clinical Trials of Southwest Louisiana, LLC
Lake Charles, Louisiana, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
St. Louis Pain Consultants
Chesterfield, Missouri, United States
Comprehensive and Interventional Pain Management LLP
Henderson, Nevada, United States
Innovative Pain Care Center
Las Vegas, Nevada, United States
Interventional Spine Medicine
Barrington, New Hampshire, United States
New Jersey Regenerative Institute
Cedar Knolls, New Jersey, United States
New York - Presbyterian Queens
Flushing, New York, United States
Drug Trials America
Hartsdale, New York, United States
Ainsworth Institute Of Pain Management
New York, New York, United States
University of Rochester- Neuromedicine Pain Management Center
Rochester, New York, United States
The Center for Clinical Research
Winston-Salem, North Carolina, United States
Clinical Inquest Center Ltd
Beavercreek, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
META Medical Research Institute
Dayton, Ohio, United States
Medical Research International
Oklahoma City, Oklahoma, United States
Oklahoma City Clinical Research Center
Oklahoma City, Oklahoma, United States
Main Line Spine
King of Prussia, Pennsylvania, United States
Clinical Trials of South Carolina
Charleston, South Carolina, United States
SC Pain & Spine Specialists
Murrells Inlet, South Carolina, United States
Ascension Spine and Scoliosis Center
Austin, Texas, United States
HRMD Research
Dallas, Texas, United States
Advanced Medical Trials
Georgetown, Texas, United States
Interventional Pain Specialists
Pasadena, Texas, United States
ARH Research, LLC.
The Woodlands, Texas, United States
JBR Clinical Research
Salt Lake City, Utah, United States
University of Virginia Orthopaedic Spine Center
Charlottesville, Virginia, United States
Virginia iSpine Physicians, P.C.
Richmond, Virginia, United States
Gershon Pain Specialists
Virginia Beach, Virginia, United States
Swedish Pain Management
Seattle, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
Countries
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References
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Macadaeg KE, Kim KD, Gupta PB, Rivera J, Patel A, Chauhan K, Watanabe J, Seo T, Zucker E, Candido K. Impact of Condoliase on Health-related Quality of Life in Participants With Radicular Leg Pain Associated With Lumbar Disk Herniation: Results From a United States Phase 3 Clinical Trial. Spine (Phila Pa 1976). 2025 Jun 15;50(12):796-803. doi: 10.1097/BRS.0000000000005327. Epub 2025 Mar 11.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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6603 /1133
Identifier Type: -
Identifier Source: org_study_id
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