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This study is to evaluate the effectiveness of a single-dose intervertebral disc injection of SI-6603 in subjects with lumbar disc herniation (LDH)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SI-6603 | Experimental | 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. |
|
| Sham | Sham Comparator | Sham injection For patients in the control group, a solution was not prepared and the needle was not placed in the intervertebral disc. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SI-6603 | Drug | SI-6603 will be injected into an intervertebral disc. |
| |
| 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 | 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 |
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Delta Clinical Research | Mobile | Alabama | 36609 | United States | ||
| Pain Medicine Associates, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40066868 | Derived | Macadaeg KE, Kim KD, Gupta PB, Rivera J, Patel A, Chauhan K, Watanabe J, Seo T, Zucker E, Candido K. Impact of Condoliase on Health-related Quality of Life in Participants With Radicular Leg Pain Associated With Lumbar Disk Herniation: Results From a United States Phase 3 Clinical Trial. Spine (Phila Pa 1976). 2025 Jun 15;50(12):796-803. doi: 10.1097/BRS.0000000000005327. Epub 2025 Mar 11. | |
| 39168360 |
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A total of 807 subjects were screened for enrollment. Of the 352 subjects randomized in the study, 176 were randomized to the SI-6603 group and 176 were randomized to the sham control group. Study drug was received by 169 SI-6603 subjects, and 172 subjects underwent sham control. The reasons for discontinuation from the study before injection were 'withdrawal of consent' (4), 'failure to meet randomization criteria' (3), 'other' (3) and 'physician decision' (1).
Sixty sites screened at least 1 subject, and 41 of these sites enrolled at least 1 subject. The first participant was enrolled in November 2018 and the last participant was enrolled in March 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Sham |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 14, 2020 | Feb 26, 2025 |
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| Sham injection |
| Drug |
The injection will be performed without needle placement into an intervertebral disc. |
|
| baseline and 52 weeks |
| Change From Baseline to Week 13 in Herniation Volume | 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 | 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 |
| Fountain Valley |
| California |
| 92708 |
| United States |
| University of California San Diego - Center for Pain Medicine | La Jolla | California | 92037 | United States |
| The Helm Center for Pain Management | Laguna Woods | California | 92637 | United States |
| The Anand Spine Group | Los Angeles | California | 90048 | United States |
| VA Greater Los Angeles Healthcare System | Los Angeles | California | 90073 | United States |
| Samaritan Center for Medical Research | Los Gatos | California | 95032 | United States |
| UC Davis Spine Center | Sacramento | California | 95816 | United States |
| Source Healthcare | Santa Monica | California | 90403 | United States |
| Boulder Neurosurgical Associates | Boulder | Colorado | 80303 | United States |
| DBPS Research, LLC | Greenwood Village | Colorado | 80111 | United States |
| International Spine, Pain, and Performance Center | Washington D.C. | District of Columbia | 20006 | United States |
| Florida Spine Institute | Clearwater | Florida | 33765 | United States |
| Spine and Orthopedic Center | Deerfield Beach | Florida | 33441 | United States |
| Deland Clinical research Unit | DeLand | Florida | 32720 | United States |
| Science Connections, LLC | Doral | Florida | 33166 | United States |
| Coastal Clinical Research | Fernandina Beach | Florida | 32034 | United States |
| Holy Cross Medical Group | Fort Lauderdale | Florida | 33334 | United States |
| Coastal Clinical Research | Jacksonville | Florida | 32224 | United States |
| Genoma Research Group, Inc. | Miami | Florida | 33155 | United States |
| Science Connections, LLC (Kendall) | Miami | Florida | 33175 | United States |
| AMPM Research Clinic | Miami Gardens | Florida | 33169 | United States |
| Pain Relief Centers | St. Petersburg | Florida | 33709 | United States |
| Pain Relief Centers | Sun City Center | Florida | 33573 | United States |
| Tampa Pain Relief Center | Tampa | Florida | 33603 | United States |
| Florida Pain Relief Group, PLLC | Tampa | Florida | 33614 | United States |
| Premier Medical Associates | The Villages | Florida | 32159 | United States |
| Conquest Research | Winter Park | Florida | 32789 | United States |
| Augusta University - Medical College of Georgia | Augusta | Georgia | 30912 | United States |
| Georgia Institute for Clinical Research, LLC | Marietta | Georgia | 30060 | United States |
| Injury Care Research | Boise | Idaho | 83713 | United States |
| Millennium Pain Center | Bloomington | Illinois | 61704 | United States |
| Chicago Anesthesia Pain Specialists | Chicago | Illinois | 60657 | United States |
| Indiana Spine Group | Carmel | Indiana | 46032 | United States |
| Neuroscience Research Center LLC | Overland Park | Kansas | 66210 | United States |
| OtriMed Clinical Research | Edgewood | Kentucky | 41017 | United States |
| Clinical Trials of Southwest Louisiana, LLC | Lake Charles | Louisiana | 70601 | United States |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | United States |
| St. Louis Pain Consultants | Chesterfield | Missouri | 63017 | United States |
| Comprehensive and Interventional Pain Management LLP | Henderson | Nevada | 89052 | United States |
| Innovative Pain Care Center | Las Vegas | Nevada | 89106 | United States |
| Interventional Spine Medicine | Barrington | New Hampshire | 03825 | United States |
| New Jersey Regenerative Institute | Cedar Knolls | New Jersey | 07927 | United States |
| New York - Presbyterian Queens | Flushing | New York | 11355 | United States |
| Drug Trials America | Hartsdale | New York | 10530 | United States |
| Ainsworth Institute Of Pain Management | New York | New York | 10022 | United States |
| University of Rochester- Neuromedicine Pain Management Center | Rochester | New York | 14618 | United States |
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Clinical Inquest Center Ltd | Beavercreek | Ohio | 45431 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| META Medical Research Institute | Dayton | Ohio | 45432 | United States |
| Medical Research International | Oklahoma City | Oklahoma | 73109 | United States |
| Oklahoma City Clinical Research Center | Oklahoma City | Oklahoma | 73159 | United States |
| Main Line Spine | King of Prussia | Pennsylvania | 19406 | United States |
| Clinical Trials of South Carolina | Charleston | South Carolina | 29406 | United States |
| SC Pain & Spine Specialists | Murrells Inlet | South Carolina | 29576 | United States |
| Ascension Spine and Scoliosis Center | Austin | Texas | 78731 | United States |
| HRMD Research | Dallas | Texas | 75240 | United States |
| Advanced Medical Trials | Georgetown | Texas | 78628 | United States |
| Interventional Pain Specialists | Pasadena | Texas | 77505 | United States |
| ARH Research, LLC. | The Woodlands | Texas | 77382 | United States |
| JBR Clinical Research | Salt Lake City | Utah | 84107 | United States |
| University of Virginia Orthopaedic Spine Center | Charlottesville | Virginia | 22903 | United States |
| Virginia iSpine Physicians, P.C. | Richmond | Virginia | 23235 | United States |
| Gershon Pain Specialists | Virginia Beach | Virginia | 23454 | United States |
| Swedish Pain Management | Seattle | Washington | 98122 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| Derived |
| Kim KD, Ahadian F, Hassanzadeh H, Rivera J, Candido K, Gershon S, Patel A, Gupta PB, Miller AE, Formoso FJ, Fuerst T, Zucker E, Seo T, Watanabe J, Matsuyama Y, Chiba K, Macadaeg KE. A phase 3, randomized, double-blind, sham-controlled trial of SI-6603 (condoliase) in patients with radicular leg pain associated with lumbar disc herniation. Spine J. 2024 Dec;24(12):2285-2296. doi: 10.1016/j.spinee.2024.08.006. Epub 2024 Aug 19. |
Sham injection
For patients in the control group, a solution was not prepared, and the needle was not placed in the intervertebral disc.
| Injected |
|
| Evaluated Week 13 |
|
| COMPLETED | Week 52 |
|
| NOT COMPLETED |
|
|
Modified intention-to-treat population
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Sham | Sham injection For patients in the control group, a solution was not prepared, and the needle was not placed in the intervertebral disc. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kilograms per square meter |
| |||||||||||||||
| Smoking History | Count of Participants | Participants |
| ||||||||||||||||
| Occupation | Count of Participants | Participants |
| ||||||||||||||||
| Days of Onset of Current Leg Pain | Mean | Standard Deviation | days |
| |||||||||||||||
| Herniation Site | L4-L5=The disc between the 4th and 5th lumbar vertebra; L5-S1=The disc between the 5th lumbar vertebra and 1st sacral vertebra | Count of Participants | Participants |
| |||||||||||||||
| Worst Leg Pain (VAS) | The average of 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. | Mean | Standard Deviation | mm |
| ||||||||||||||
| Worst Back Pain (VAS) | The average of worst back 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. | Mean | Standard Deviation | mm |
| ||||||||||||||
| ODI score | The Oswestry Disability Index (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. | Mean | Standard Deviation | percentage of disability |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Week 13 in Average Worst Leg Pain Score During the Past 24 Hours Over the Previous 7 Days | 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. | Modified intention-to-treat population | Posted | Least Squares Mean | Standard Error | units on a scale | baseline and 13 weeks |
|
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| Secondary | Change From Baseline to Week 52 in Average Worst Leg Pain Score During the Past 24 Hours Over the Previous 7 Days | 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. | Modified intention-to-treat population | Posted | Least Squares Mean | Standard Error | units on a scale | baseline and 52 weeks |
|
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| Secondary | Change From Baseline to Week 13 in Herniation Volume | 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. | Modified intention-to-treat population | Posted | Least Squares Mean | Standard Error | mm^3 | baseline and 13 weeks |
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| Secondary | Change From Baseline to Week 13 in Oswestry Disability Index (ODI) Score | 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. | Modified intention-to-treat population | Posted | Least Squares Mean | Standard Error | percentage of disability | baseline and 13 weeks |
|
|
52 weeks
The safety population was defined as all randomized subjects who received the study injection, analyzed according to the treatments subjects received. Two subjects who were randomized to SI-6603, received the sham. These two subjects were analyzed as part of the sham group for safety analyses.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 1 | 167 | 7 | 167 | 91 | 167 |
| EG001 | Sham | Sham injection For patients in the control group, a solution was not prepared, and the needle was not placed in the intervertebral disc. | 0 | 174 | 6 | 174 | 62 | 174 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bladder perforation | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Magnetic resonance imaging spinal abnormal | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Spinal X-ray abnormal | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Sciatica | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
PI do not make any publication of trial results without the written permission of sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| General Manager, Clinical Development Department | Seikagaku Corporation | (81)3-5220-8593 | reply@seikagaku.co.jp |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 12, 2023 | Feb 26, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| D011843 | Radiculopathy |
| D012585 | Sciatica |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D020426 | Sciatic Neuropathy |
| D020422 | Mononeuropathies |
| D009437 | Neuralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Past smoker |
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| Current smoker |
|
| Light labor |
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| L5-S1 |
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