Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain

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.

Timeline

Start

2019-11-04

Primary completion

2022-02-21

Completion

2022-06-21

Drugs

Indications