- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01282606
Clinical Trial to Assess Safety of SI-6603 in Patients With Lumbar Disc Herniation
March 21, 2023 updated by: Seikagaku Corporation
An Open Label, Non-randomized Dose-escalation Study to Assess Safety and Tolerability of SI-6603 in Patients With Lumbar Disc Herniation (Phase II Study)
The purpose of this study is to evaluate the safety of SI-6603 in lumbar disc herniation patients.
Study Overview
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 2
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
-
-
California
-
Encinitas, California, United States, 92024
- SKK
-
-
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
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with lumbar disc herniation (L4-L5 or L5-S1) as assessed by MRI and clinical symptoms corresponding to position of the impaired nerve root.
- Patients assessed as positive in the SLR test.
- Patients with sciatica in either lower leg.
- Patients with no improvement from pharmacotherapy or concomitant treatment with drug and nerve block.
Exclusion Criteria:
- Patients who have 2 or more lumbar disc herniations as assessed by MRI.
- Patients with "extrusion-type" or "sequestration-type" herniation in whom a rupture into the posterior longitudinal ligament is identified by MRI.
- Patients who have received nerve block within 3 weeks before screening.
- Patients who have undergone lumbar operation, chemonucleolysis, or percutaneous nucleotomy.
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Drug I: SI-6603 (Low)
|
SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
|
Experimental: Drug II: SI-6603 (Middle)
|
SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
|
Experimental: Drug III: SI-6603 (High)
|
SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events
Time Frame: 52 weeks
|
52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The leg pain
Time Frame: At each assessment time point
|
At each assessment time point
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
December 1, 2007
Primary Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
January 24, 2011
First Submitted That Met QC Criteria
January 24, 2011
First Posted (Estimate)
January 25, 2011
Study Record Updates
Last Update Posted (Actual)
March 23, 2023
Last Update Submitted That Met QC Criteria
March 21, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6603/1121
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.
Clinical Trials on Lumbar Vertebra Hernia
-
Seikagaku CorporationCompleted
-
St. Louis UniversityTerminatedCompression Fracture of Thoracic Vertebral Body | Thoracic Fracture | Lumbar Fracture | Compression Fracture of Lumbar Spine | Burst Fracture of Thoracic Vertebra | Burst Fracture of Lumbar VertebraUnited States
-
University of VirginiaCompletedCollapse of Thoracic Vertebra | Collapse of Lumbar VertebraeUnited States
-
Groupe Hospitalier Paris Saint JosephTerminated
-
University Hospital, BordeauxBiom'Up France SASCompletedDegenerative Osteoarthritis | Degenerative Lumbar VertebraFrance
-
University of MichiganWashington University School of Medicine; LFR InternationalCompletedCervical Vertebra Injury | Cervical Vertebra FractureUnited States
-
Chang Gung Memorial HospitalCompletedLumbosacral Transitional VertebraTaiwan
-
Intrinsic TherapeuticsWithdrawnLumbar Disc Herniation | Anular Tear of Lumbar Disc | Nucleus Pulp Hernia;LumbosacUnited States
-
Allina Health SystemTwin Cities Spine CenterRecruitingLumbar Disc Herniation | Lumbar Spinal Stenosis | Lumbar Spondylolisthesis | Lumbar Disc DiseaseUnited States
-
Shin Kong Wu Ho-Su Memorial HospitalTerminatedLumbar Disc Herniation | Lumbar Traction | Spinal Manipulation | Lumbar SurgeryTaiwan
Clinical Trials on SI-6603
-
Seikagaku CorporationCompleted
-
Seikagaku CorporationCompletedLumbar Disc HerniationUnited States
-
Sichuan Baili Pharmaceutical Co., Ltd.RecruitingNon-small Cell Lung CancerChina
-
Hyub HuhCompleted
-
Sichuan Baili Pharmaceutical Co., Ltd.RecruitingSquamous Cell Carcinoma of Head and NeckChina
-
Virginia Commonwealth UniversityCompletedMotor Coordination or Function; Developmental DisorderUnited States
-
Sichuan Baili Pharmaceutical Co., Ltd.SystImmune Inc.Completed
-
Globus Medical IncCompletedJoint DysfunctionUnited States
-
Nordsjaellands HospitalUnknownInflammatory Bowel DiseaseDenmark
-
VA Office of Research and DevelopmentCompletedSuicidal Ideation | Treatment EngagementUnited States