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Clinical Trials/ACTRN12619001235190
ACTRN12619001235190CompletedPhase 1

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

SpineThera Australia PTY LTD0 sites55 target enrollmentStarted: September 6, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
55
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomised controlled trial
Primary Purpose
Treatment
Masking
Blinded (masking used)

Eligibility Criteria

Ages
18 Years to 65 Years (—)
Sex
All

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 more than 5.0 and less than 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

  • •- 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, spinal
  • •stenosis, or spondylolisthesis
  • •- Has Diabetes Mellitus (Type 1 or Type 2)
  • •- 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

Investigators

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