Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain
- Registration Number
- NCT03952377
- Lead Sponsor
- SpineThera Australia PTY LTD
- Brief Summary
This is a Phase I/II, double-blind, parallel-group, randomized, placebo-controlled multi-centre trial in 180 patients randomized 1:1:1 to receive the IMP (Dexamethasone acetate microspheres for extended-release injectable micro-suspension, SX600 at 12.5 mg or 25.0 mg) or Placebo (0.9% Sodium Chloride for Injection, BP) via transforaminal epidural injection to the lumbosacral epidural space.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 56
- Adult aged 18 to 65 years, capable of providing informed consent, capable of complying with the outcome instruments, and meeting the attendance requirements for review as defined in the study
- 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
Main
- Documented history of allergy or intolerance to components of the Investigational Medicinal Product, relevant radiologic contrast media, or local anaesthetics
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 12.5 mg SX600 SX600 Low Dose 0.9% Sodium Chloride for Injection Placebo - 25.0 mg SX600 SX600 High Dose
- Primary Outcome Measures
Name Time Method The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders). Baseline to 60 days
- Secondary Outcome Measures
Name Time Method Change in Functional Outcomes as Measured by Patient's Global Impression of Change Baseline, 14, 30, 60, 90, 120, 150, and 180 days Very much improved, or much improved from baseline
Change From Baseline in Short Form 36 Questionnaire (SF-36) Baseline, 14, 30, 60, 90, 120, 150, and 180 days SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each health concept has a range of possible total scores from 0 to 100. A high score defines a more favorable health state. The mean overall total score will be reported.
The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain) Baseline to 14, 30, 60, 90, 120, 150, and 180 days Change in Functional Outcomes as Measured by the Oswestry Disability Index Baseline, 14, 30, 60, 90, 120, 150, and 180 days 0 - 20%: Minimal disability 21% - 40%: Moderate disability 41% - 60%: Severe disability 61% - 80%: Crippling back pain 81% - 100%: Bed-bound or exaggerating their symptoms
The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain) Baseline to 14, 30, 60, 90, 120, 150, and 180 days Time to Loss of Response in the Subset of Patients Who Are Responders at Day 14 (50% or Greater Improvement in Mean Worst Daily Leg Pain) Day 14 through 180 days Proportion of Subjects Who Required Rescue Medication, as Reported in Patient Diary Baseline through 180 days
Trial Locations
- Locations (10)
Research Site 10
🇦🇺Blacktown, Australia
Research Site 05
🇦🇺Newcastle, Australia
Research Site 06
🇦🇺Frankston, Australia
Research Site 11
🇦🇺Sydney, Australia
Research Site 02
🇦🇺Sydney, Australia
Research Site 04
🇦🇺Sydney, Australia
Research Site 09
🇦🇺Sydney, Australia
Research Site 03
🇦🇺Adelaide, Australia
Research Site 12
🇦🇺Adelaide, Australia
Research Site 08
🇦🇺Townsville, Australia