Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain
Status:
Recruiting
Trial end date:
2022-09-01
Target enrollment:
Participant gender:
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.