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

July 11, 2025 updated by: Seikagaku Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
352

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

26 years to 66 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: SI-6603
SI-6603 will be injected into an intervertebral disc.
Sham Comparator: Sham

Sham injection

For patients in the control group, a solution was not prepared and the needle was not placed in the intervertebral disc.
Drug: Sham injection
The injection will be performed without needle placement into an intervertebral disc.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 13 in Average Worst Leg Pain Score During the Past 24 Hours Over the Previous 7 Days
Time Frame: baseline and 13 weeks
The primary endpoint was the change from baseline to Week 13 in average worst leg pain score during the past 24 hours over the previous 7 days, as assessed by 100 mm Visual Analog Scale (VAS). VAS is a pain assessment tool with 0 mm representing an absence of pain, and 100 mm representing the worst pain patients have ever experienced.
baseline and 13 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 52 in Average Worst Leg Pain Score During the Past 24 Hours Over the Previous 7 Days
Time Frame: baseline and 52 weeks
One of the key secondary endpoints was the change from baseline to Week 52 in average worst leg pain score during the past 24 hours over the previous 7 days, as assessed by 100 mm Visual Analog Scale (VAS). VAS is a pain assessment tool with 0 mm representing an absence of pain, and 100 mm representing the worst pain patients have ever experienced.
baseline and 52 weeks
Change From Baseline to Week 13 in Herniation Volume
Time Frame: baseline and 13 weeks
One of the key secondary endpoints was change from baseline to Week 13 in herniation volume. Herniation volumes were assessed with MRI by a central imaging facility.
baseline and 13 weeks
Change From Baseline to Week 13 in Oswestry Disability Index (ODI) Score
Time Frame: baseline and 13 weeks
One of the key secondary endpioints was change from baseline to Week 13 in Oswestry Disability Index (ODI) score. The ODI questionnaire is designed to provide information as to how the patient's back (or leg) pain affects their ability to manage in everyday life. A higher score on the ODI indicates a more severe disability. The final index score is calculated as a percentage, with 0% indicating no disability and 100% indicating highest disability.
baseline and 13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seikagaku Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 3, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 21, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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