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

A Multicenter, Randomized, Double-blind, Sham-controlled, Comparative Study of SI-6603 in Subjects With Lumbar Disc Herniation (Phase 3)

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

Study Overview

• Status: Completed
• Conditions: Lumbar Disc Herniation
• Intervention / Treatment: Drug: SI-6603; Drug: Sham injection

• Study Type: Interventional
• Enrollment (Actual): 352
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36609
      • Delta Clinical Research
  • California
    • Fountain Valley, California, United States, 92708
      • Pain Medicine Associates, Inc.
    • La Jolla, California, United States, 92037
      • University of California San Diego - Center for Pain Medicine
    • Laguna Woods, California, United States, 92637
      • The Helm Center for Pain Management
    • Los Angeles, California, United States, 90073
      • VA Greater Los Angeles Healthcare System
    • Los Angeles, California, United States, 90048
      • The Anand Spine Group
    • Los Gatos, California, United States, 95032
      • Samaritan Center for Medical Research
    • Sacramento, California, United States, 95816
      • UC Davis Spine Center
    • Santa Monica, California, United States, 90403
      • Source Healthcare
  • Colorado
    • Boulder, Colorado, United States, 80303
      • Boulder Neurosurgical Associates
    • Greenwood Village, Colorado, United States, 80111
      • DBPS Research, LLC
  • District of Columbia
    • Washington, District of Columbia, United States, 20006
      • International Spine, Pain, and Performance Center
  • Florida
    • Clearwater, Florida, United States, 33765
      • Florida Spine Institute
    • DeLand, Florida, United States, 32720
      • Deland Clinical research Unit
    • Deerfield Beach, Florida, United States, 33441
      • Spine and Orthopedic Center
    • Doral, Florida, United States, 33166
      • Science Connections, LLC
    • Fernandina Beach, Florida, United States, 32034
      • Coastal Clinical Research
    • Fort Lauderdale, Florida, United States, 33334
      • Holy Cross Medical Group
    • Jacksonville, Florida, United States, 32224
      • Coastal Clinical Research
    • Miami, Florida, United States, 33155
      • Genoma Research Group, Inc.
    • Miami, Florida, United States, 33175
      • Science Connections, LLC (Kendall)
    • Miami Gardens, Florida, United States, 33169
      • AMPM Research Clinic
    • Saint Petersburg, Florida, United States, 33709
      • Pain Relief Centers
    • Sun City Center, Florida, United States, 33573
      • Pain Relief Centers
    • Tampa, Florida, United States, 33603
      • Tampa Pain Relief Center
    • Tampa, Florida, United States, 33614
      • Florida Pain Relief Group, PLLC
    • The Villages, Florida, United States, 32159
      • Premier Medical Associates
    • Winter Park, Florida, United States, 32789
      • Conquest Research
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University - Medical College of Georgia
    • Marietta, Georgia, United States, 30060
      • Georgia Institute for Clinical Research, LLC
  • Idaho
    • Boise, Idaho, United States, 83713
      • Injury Care Research
  • Illinois
    • Bloomington, Illinois, United States, 61704
      • Millennium Pain Center
    • Chicago, Illinois, United States, 60657
      • Chicago Anesthesia Pain Specialists
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Indiana Spine Group
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Neuroscience Research Center LLC
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Otrimed Clinical Research
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Clinical Trials of Southwest Louisiana, LLC
    • New Orleans, Louisiana, United States, 70112
      • Tulane University School of Medicine
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • St. Louis Pain Consultants
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Comprehensive and Interventional Pain Management Llp
    • Las Vegas, Nevada, United States, 89106
      • Innovative Pain Care Center
  • New Hampshire
    • Barrington, New Hampshire, United States, 03825
      • Interventional Spine Medicine
  • New Jersey
    • Cedar Knolls, New Jersey, United States, 07927
      • New Jersey Regenerative Institute
  • New York
    • Flushing, New York, United States, 11355
      • New York - Presbyterian Queens
    • Hartsdale, New York, United States, 10530
      • Drug Trials America
    • New York, New York, United States, 10022
      • Ainsworth Institute Of Pain Management
    • Rochester, New York, United States, 14618
      • University of Rochester- Neuromedicine Pain Management Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research
  • Ohio
    • Beavercreek, Ohio, United States, 45431
      • Clinical Inquest Center Ltd
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
    • Dayton, Ohio, United States, 45432
      • META Medical Research Institute
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73109
      • Medical Research International
    • Oklahoma City, Oklahoma, United States, 73159
      • Oklahoma City Clinical Research Center
  • Pennsylvania
    • King Of Prussia, Pennsylvania, United States, 19406
      • Main Line Spine
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Clinical Trials of South Carolina
    • Murrells Inlet, South Carolina, United States, 29576
      • SC Pain & Spine Specialists
  • Texas
    • Austin, Texas, United States, 78731
      • Ascension Spine and Scoliosis Center
    • Dallas, Texas, United States, 75240
      • HRMD Research
    • Georgetown, Texas, United States, 78628
      • Advanced Medical Trials
    • Pasadena, Texas, United States, 77505
      • Interventional Pain Specialists
    • The Woodlands, Texas, United States, 77382
      • ARH Research, LLC.
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • JBR Clinical Research
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Orthopaedic Spine Center
    • Richmond, Virginia, United States, 23235
      • Virginia iSpine Physicians, P.C.
    • Virginia Beach, Virginia, United States, 23454
      • Gershon Pain Specialists
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Pain Management
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham injection	Drug: Sham injection; The injection will be performed without needle placement into an intervertebral disc.
Experimental: SI-6603	Drug: SI-6603; SI-6603 will be injected into an intervertebral disc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average worst leg pain score during the past 24 hours over the previous 7 days	Assessed by 100 mm Visual Analog Scale (VAS)	13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average worst leg pain score during the past 24 hours over the previous 7 days	Assessed by 100 mm Visual Analog Scale (VAS)	52 weeks
Herniation volume assessed by MRI		13 weeks
Oswestry Disability Index (ODI) score		13 weeks

Collaborators and Investigators

• Sponsor: Seikagaku Corporation

Publications and helpful links

Helpful Links

• Study website

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2018
• Primary Completion (Actual): August 3, 2022
• Study Completion (Actual): March 21, 2023

Study Registration Dates

• First Submitted: July 24, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Sciatica; Lumbar disc herniation; Radiculopathy; Chemonucleolysis; Intradiscal injection
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: 6603 /1133

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No