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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
Research Site 03
Adelaide, Australia
Research Site 12
Adelaide, Australia
Research Site 10
Blacktown, Australia
Research Site 06
Frankston, Australia
The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders).
Time frame: Baseline to 60 days
The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain)
Time frame: Baseline to 14, 30, 60, 90, 120, 150, and 180 days
Change in Functional Outcomes as Measured by Patient's Global Impression of Change
Very much improved, or much improved from baseline
Time frame: Baseline, 14, 30, 60, 90, 120, 150, and 180 days
Change in Functional Outcomes as Measured by the Oswestry Disability Index
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
Time frame: Baseline, 14, 30, 60, 90, 120, 150, and 180 days
Change From Baseline in Short Form 36 Questionnaire (SF-36)
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.
Time frame: Baseline, 14, 30, 60, 90, 120, 150, and 180 days
The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain)
Time frame: Baseline to 14, 30, 60, 90, 120, 150, and 180 days
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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
Proportion of Subjects Who Required Rescue Medication, as Reported in Patient Diary
Time frame: Baseline through 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)
Time frame: Day 14 through 180 days