Clinical trial NCT03607838: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lumbar Disc Herniation
Keywords: Lumbar disc herniation
Radiculopathy
Sciatica
Intradiscal injection
Chemonucleolysis
Lead sponsor: Seikagaku Corporation
Sponsor class: INDUSTRY
First posted: 2018-07-31
Enrollment: 352
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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.

Primary outcomes:
measure: Average worst leg pain score during the past 24 hours over the previous 7 days
timeFrame: 13 weeks
Secondary outcomes:
measure: Average worst leg pain score during the past 24 hours over the previous 7 days
timeFrame: 52 weeks
measure: Herniation volume assessed by MRI
timeFrame: 13 weeks
measure: Oswestry Disability Index (ODI) score
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Delta Clinical Research
state: Alabama
city: Fountain Valley
country: United States
facility: Pain Medicine Associates, Inc.
state: California
city: La Jolla
country: United States
facility: University of California San Diego - Center for Pain Medicine
state: California
city: Laguna Woods
country: United States
facility: The Helm Center for Pain Management
state: California
city: Los Angeles
country: United States
facility: The Anand Spine Group
state: California
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
city: Los Gatos
country: United States
facility: Samaritan Center for Medical Research
state: California
city: Sacramento
country: United States
facility: UC Davis Spine Center
state: California
city: Santa Monica
country: United States
facility: Source Healthcare
state: California
city: Boulder
country: United States
facility: Boulder Neurosurgical Associates
state: Colorado
city: Greenwood Village
country: United States
facility: DBPS Research, LLC
state: Colorado
city: Washington
country: United States
facility: International Spine, Pain, and Performance Center
state: District of Columbia
city: Clearwater
country: United States
facility: Florida Spine Institute
state: Florida
city: Deerfield Beach
country: United States
facility: Spine and Orthopedic Center
state: Florida
city: DeLand
country: United States
facility: Deland Clinical research Unit
state: Florida
city: Doral
country: United States
facility: Science Connections, LLC
state: Florida
city: Fernandina Beach
country: United States
facility: Coastal Clinical Research
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Medical Group
state: Florida
city: Jacksonville
country: United States
facility: Coastal Clinical Research
state: Florida
city: Miami Gardens
country: United States
facility: AMPM Research Clinic
state: Florida
city: Miami
country: United States
facility: Genoma Research Group, Inc.
state: Florida
city: Miami
country: United States
facility: Science Connections, LLC (Kendall)
state: Florida
city: Saint Petersburg
country: United States
facility: Pain Relief Centers
state: Florida
city: Sun City Center
country: United States
facility: Pain Relief Centers
state: Florida
city: Tampa
country: United States
facility: Tampa Pain Relief Center
state: Florida
city: Tampa
country: United States
facility: Florida Pain Relief Group, PLLC
state: Florida
city: The Villages
country: United States
facility: Premier Medical Associates
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Augusta
country: United States
facility: Augusta University - Medical College of Georgia
state: Georgia
city: Marietta
country: United States
facility: Georgia Institute for Clinical Research, LLC
state: Georgia
city: Boise
country: United States
facility: Injury Care Research
state: Idaho
city: Bloomington
country: United States
facility: Millennium Pain Center
state: Illinois
city: Chicago
country: United States
facility: Chicago Anesthesia Pain Specialists
state: Illinois
city: Carmel
country: United States
facility: Indiana Spine Group
state: Indiana
city: Overland Park
country: United States
facility: Neuroscience Research Center LLC
state: Kansas
city: Edgewood
country: United States
facility: OtriMed Clinical Research
state: Kentucky
city: Lake Charles
country: United States
facility: Clinical Trials of Southwest Louisiana, LLC
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: Chesterfield
country: United States
facility: St. Louis Pain Consultants
state: Missouri
city: Henderson
country: United States
facility: Comprehensive and Interventional Pain Management LLP
state: Nevada
city: Las Vegas
country: United States
facility: Innovative Pain Care Center
state: Nevada
city: Barrington
country: United States
facility: Interventional Spine Medicine
state: New Hampshire
city: Cedar Knolls
country: United States
facility: New Jersey Regenerative Institute
state: New Jersey
city: Flushing
country: United States
facility: New York - Presbyterian Queens
state: New York
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: New York
country: United States
facility: Ainsworth Institute Of Pain Management
state: New York
city: Rochester
country: United States
facility: University of Rochester- Neuromedicine Pain Management Center
state: New York
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Beavercreek
country: United States
facility: Clinical Inquest Center Ltd
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Dayton
country: United States
facility: META Medical Research Institute
state: Ohio
city: Oklahoma City
country: United States
facility: Medical Research International
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma City Clinical Research Center
state: Oklahoma
city: King Of Prussia
country: United States
facility: Main Line Spine
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Murrells Inlet
country: United States
facility: SC Pain & Spine Specialists
state: South Carolina
city: Austin
country: United States
facility: Ascension Spine and Scoliosis Center
state: Texas
city: Dallas
country: United States
facility: HRMD Research
state: Texas
city: Georgetown
country: United States
facility: Advanced Medical Trials
state: Texas
city: Pasadena
country: United States
facility: Interventional Pain Specialists
state: Texas
city: The Woodlands
country: United States
facility: ARH Research, LLC.
state: Texas
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Orthopaedic Spine Center
state: Virginia
city: Richmond
country: United States
facility: Virginia iSpine Physicians, P.C.
state: Virginia
city: Virginia Beach
country: United States
facility: Gershon Pain Specialists
state: Virginia
city: Seattle
country: United States
facility: Swedish Pain Management
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
References: