Trial | NCT03952377  Report issue

Title

Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Phase I/II, First-in-Human Study to Assess the Safety and Efficacy of Two Doses of SX600 Administered by Lumbosacral Transforaminal Epidural Injection in Patients With Radicular Pain Secondary to Lumbar Intervertebral Disc Herniation

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    SX600 ...

  • Study Participants

    55
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 Started
Nov 04
2019
Primary Completion
Feb 21
2022
Study Completion
Jun 21
2022
Last Update
Aug 02
2022

Drug SX600

Transforaminal Epidural Injection

Drug Placebo

Transforaminal Epidural Injection

25.0 mg SX600 Experimental

High Dose

0.9% Sodium Chloride for Injection Placebo Comparator

12.5 mg SX600 Experimental

Low Dose

Criteria 

Main Inclusion Criteria:

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 Exclusion Criteria:

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
No Results Posted