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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date06 Sep 1973 |
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
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.
100 Clinical Results associated with SpineThera Australia PTY LTD
0 Patents (Medical) associated with SpineThera Australia PTY LTD
100 Deals associated with SpineThera Australia PTY LTD
100 Translational Medicine associated with SpineThera Australia PTY LTD