Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain
NCT ID: NCT03952377
Last Updated: 2024-01-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
56 participants
INTERVENTIONAL
2019-11-04
2022-06-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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0.9% Sodium Chloride for Injection
Placebo
Transforaminal Epidural Injection
12.5 mg SX600
Low Dose
SX600
Transforaminal Epidural Injection
25.0 mg SX600
High Dose
SX600
Transforaminal Epidural Injection
Interventions
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SX600
Transforaminal Epidural Injection
Placebo
Transforaminal Epidural Injection
Eligibility Criteria
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Inclusion Criteria
* Presenting with a history of radicular pain of duration of 4 weeks to 6 months, having failed conservative therapy.
* Mean Worst Daily Leg Pain score of ≥5.0 and ≤9.0
* Women of child-bearing potential must use a medically accepted method of contraception for the duration of the study plus 30 days and register a negative pregnancy test prior to dosing
Exclusion Criteria
* Is pregnant or lactating
* Has been taking corticosteroid medications routinely in the past 6 months or has received an epidural corticosteroid injection within 12 weeks of screening
* Has a BMI greater than 40 kg/m2
* Has radiological evidence of clinically significant foraminal stenosis at L4-L5 or L5-S1 or of clinically significant spinal stenosis, or spondylolisthesis (Grade 2 or higher). (Note, asymptomatic foraminal stenosis at other spinal levels is not excluded).
* Has Diabetes Mellitus (Type 1 or Type 2)- prior confirmed HbA1c or OGTT
* Has a history of significant leg pain unrelated to disc herniation that would significantly compromise assessment of back or leg radicular pain
* Has had lumbar back surgery
* Has received an implantable device for pain management
18 Years
65 Years
ALL
No
Sponsors
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SpineThera Australia PTY LTD
INDUSTRY
Responsible Party
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Principal Investigators
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Willem Volschenk
Role: PRINCIPAL_INVESTIGATOR
Genesis Research Services
Locations
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Research Site 03
Adelaide, , Australia
Research Site 12
Adelaide, , Australia
Research Site 10
Blacktown, , Australia
Research Site 06
Frankston, , Australia
Research Site 05
Newcastle, , Australia
Research Site 02
Sydney, , Australia
Research Site 04
Sydney, , Australia
Research Site 09
Sydney, , Australia
Research Site 11
Sydney, , Australia
Research Site 08
Townsville, , Australia
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLIN-0012-STA19-01
Identifier Type: -
Identifier Source: org_study_id
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