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

Lumbar Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03607838
• Other study ID #: 6603 /1133
• Status: Completed
• Phase: Phase 3
• Start date: May 30, 2018
• Est. completion date: March 21, 2023

Study information

• Verified date: April 2024
• Source: Seikagaku Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: March 21, 2023
• Est. primary completion date: August 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Lumbar Disc Herniation

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Augusta University - Medical College of Georgia	Augusta	Georgia
United States	Ascension Spine and Scoliosis Center	Austin	Texas
United States	Interventional Spine Medicine	Barrington	New Hampshire
United States	Clinical Inquest Center Ltd	Beavercreek	Ohio
United States	Millennium Pain Center	Bloomington	Illinois
United States	Injury Care Research	Boise	Idaho
United States	Boulder Neurosurgical Associates	Boulder	Colorado
United States	Indiana Spine Group	Carmel	Indiana
United States	New Jersey Regenerative Institute	Cedar Knolls	New Jersey
United States	Clinical Trials of South Carolina	Charleston	South Carolina
United States	University of Virginia Orthopaedic Spine Center	Charlottesville	Virginia
United States	St. Louis Pain Consultants	Chesterfield	Missouri
United States	Chicago Anesthesia Pain Specialists	Chicago	Illinois
United States	Florida Spine Institute	Clearwater	Florida
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	HRMD Research	Dallas	Texas
United States	META Medical Research Institute	Dayton	Ohio
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	OtriMed Clinical Research	Edgewood	Kentucky
United States	Coastal Clinical Research	Fernandina Beach	Florida
United States	New York - Presbyterian Queens	Flushing	New York
United States	Holy Cross Medical Group	Fort Lauderdale	Florida
United States	Pain Medicine Associates, Inc.	Fountain Valley	California
United States	Advanced Medical Trials	Georgetown	Texas
United States	DBPS Research, LLC	Greenwood Village	Colorado
United States	Drug Trials America	Hartsdale	New York
United States	Comprehensive and Interventional Pain Management LLP	Henderson	Nevada
United States	Coastal Clinical Research	Jacksonville	Florida
United States	Main Line Spine	King Of Prussia	Pennsylvania
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	Clinical Trials of Southwest Louisiana, LLC	Lake Charles	Louisiana
United States	Innovative Pain Care Center	Las Vegas	Nevada
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	Georgia Institute for Clinical Research, LLC	Marietta	Georgia
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	Delta Clinical Research	Mobile	Alabama
United States	West Virginia University	Morgantown	West Virginia
United States	SC Pain & Spine Specialists	Murrells Inlet	South Carolina
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Ainsworth Institute Of Pain Management	New York	New York
United States	Medical Research International	Oklahoma City	Oklahoma
United States	Oklahoma City Clinical Research Center	Oklahoma City	Oklahoma
United States	Neuroscience Research Center LLC	Overland Park	Kansas
United States	Interventional Pain Specialists	Pasadena	Texas
United States	Virginia iSpine Physicians, P.C.	Richmond	Virginia
United States	University of Rochester- Neuromedicine Pain Management Center	Rochester	New York
United States	UC Davis Spine Center	Sacramento	California
United States	Pain Relief Centers	Saint Petersburg	Florida
United States	JBR Clinical Research	Salt Lake City	Utah
United States	Source Healthcare	Santa Monica	California
United States	Swedish Pain Management	Seattle	Washington
United States	Pain Relief Centers	Sun City Center	Florida
United States	Florida Pain Relief Group, PLLC	Tampa	Florida
United States	Tampa Pain Relief Center	Tampa	Florida
United States	Premier Medical Associates	The Villages	Florida
United States	ARH Research, LLC.	The Woodlands	Texas
United States	Gershon Pain Specialists	Virginia Beach	Virginia
United States	International Spine, Pain, and Performance Center	Washington	District of Columbia
United States	The Center for Clinical Research	Winston-Salem	North Carolina
United States	Conquest Research	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Seikagaku Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Herniation volume assessed by MRI		13 weeks
Secondary	Oswestry Disability Index (ODI) score		13 weeks