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

Phase 3

Completed

• Conditions: Lumbar Disc Herniation
• Interventions: Drug: SI-6603; Drug: Sham injection

• Registration Number: NCT03607838
• Lead Sponsor: Seikagaku Corporation

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-30
• Study First Submitted: 2018-07-24
• Study First Submitted QC: 2018-07-24
• Study First Posted: 2018-07-31
• Primary Completion: 2022-08-03
• Study Completion: 2023-03-21
• Disposition First Submitted: 2023-07-14
• Disposition First Posted: 2023-07-18
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 352

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SI-6603	SI-6603	-
Sham injection	Sham injection	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (65)

Indiana Spine Group; 🇺🇸 Carmel, Indiana, United States

HRMD Research; 🇺🇸 Dallas, Texas, United States

Gershon Pain Specialists; 🇺🇸 Virginia Beach, Virginia, United States

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

Swedish Pain Management; 🇺🇸 Seattle, Washington, United States

Innovative Pain Care Center; 🇺🇸 Las Vegas, Nevada, United States

Advanced Medical Trials; 🇺🇸 Georgetown, Texas, United States

Ainsworth Institute Of Pain Management; 🇺🇸 New York, New York, United States

Pain Medicine Associates, Inc.; 🇺🇸 Fountain Valley, California, United States

Main Line Spine; 🇺🇸 King Of Prussia, Pennsylvania, United States

Holy Cross Medical Group; 🇺🇸 Fort Lauderdale, Florida, United States

Medical Research International; 🇺🇸 Oklahoma City, Oklahoma, United States

Drug Trials America; 🇺🇸 Hartsdale, New York, United States

ARH Research, LLC.; 🇺🇸 The Woodlands, Texas, United States

New York - Presbyterian Queens; 🇺🇸 Flushing, New York, United States

Interventional Pain Specialists; 🇺🇸 Pasadena, Texas, United States

Ascension Spine and Scoliosis Center; 🇺🇸 Austin, Texas, United States

Virginia iSpine Physicians, P.C.; 🇺🇸 Richmond, Virginia, United States

JBR Clinical Research; 🇺🇸 Salt Lake City, Utah, United States

Oklahoma City Clinical Research Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Delta Clinical Research; 🇺🇸 Mobile, Alabama, United States

VA Greater Los Angeles Healthcare System; 🇺🇸 Los Angeles, California, United States

Source Healthcare; 🇺🇸 Santa Monica, California, United States

Boulder Neurosurgical Associates; 🇺🇸 Boulder, Colorado, United States

Florida Spine Institute; 🇺🇸 Clearwater, Florida, United States

Coastal Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Deland Clinical research Unit; 🇺🇸 DeLand, Florida, United States

Genoma Research Group, Inc.; 🇺🇸 Miami, Florida, United States

Science Connections, LLC (Kendall); 🇺🇸 Miami, Florida, United States

Pain Relief Centers; 🇺🇸 Sun City Center, Florida, United States

Premier Medical Associates; 🇺🇸 The Villages, Florida, United States

Conquest Research; 🇺🇸 Winter Park, Florida, United States

Injury Care Research; 🇺🇸 Boise, Idaho, United States

Chicago Anesthesia Pain Specialists; 🇺🇸 Chicago, Illinois, United States

Millennium Pain Center; 🇺🇸 Bloomington, Illinois, United States

St. Louis Pain Consultants; 🇺🇸 Chesterfield, Missouri, United States

Comprehensive and Interventional Pain Management LLP; 🇺🇸 Henderson, Nevada, United States

Interventional Spine Medicine; 🇺🇸 Barrington, New Hampshire, United States

New Jersey Regenerative Institute; 🇺🇸 Cedar Knolls, New Jersey, United States

META Medical Research Institute; 🇺🇸 Dayton, Ohio, United States

SC Pain & Spine Specialists; 🇺🇸 Murrells Inlet, South Carolina, United States

OtriMed Clinical Research; 🇺🇸 Edgewood, Kentucky, United States

Neuroscience Research Center LLC; 🇺🇸 Overland Park, Kansas, United States

Samaritan Center for Medical Research; 🇺🇸 Los Gatos, California, United States

The Anand Spine Group; 🇺🇸 Los Angeles, California, United States

DBPS Research, LLC; 🇺🇸 Greenwood Village, Colorado, United States

The Helm Center for Pain Management; 🇺🇸 Laguna Woods, California, United States

Spine and Orthopedic Center; 🇺🇸 Deerfield Beach, Florida, United States

Science Connections, LLC; 🇺🇸 Doral, Florida, United States

University of California San Diego - Center for Pain Medicine; 🇺🇸 La Jolla, California, United States

International Spine, Pain, and Performance Center; 🇺🇸 Washington, District of Columbia, United States

AMPM Research Clinic; 🇺🇸 Miami Gardens, Florida, United States

Clinical Inquest Center Ltd; 🇺🇸 Beavercreek, Ohio, United States

Augusta University - Medical College of Georgia; 🇺🇸 Augusta, Georgia, United States

Georgia Institute for Clinical Research, LLC; 🇺🇸 Marietta, Georgia, United States

University of Virginia Orthopaedic Spine Center; 🇺🇸 Charlottesville, Virginia, United States

University of Rochester- Neuromedicine Pain Management Center; 🇺🇸 Rochester, New York, United States

Clinical Trials of Southwest Louisiana, LLC; 🇺🇸 Lake Charles, Louisiana, United States

UC Davis Spine Center; 🇺🇸 Sacramento, California, United States

Tampa Pain Relief Center; 🇺🇸 Tampa, Florida, United States

Florida Pain Relief Group, PLLC; 🇺🇸 Tampa, Florida, United States

The Center for Clinical Research; 🇺🇸 Winston-Salem, North Carolina, United States

Tulane University School of Medicine; 🇺🇸 New Orleans, Louisiana, United States

Clinical Trials of South Carolina; 🇺🇸 Charleston, South Carolina, United States