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最高研发阶段批准上市 |
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首次获批日期1973-09-06 |
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 项与 SpineThera Australia PTY LTD 相关的临床结果
0 项与 SpineThera Australia PTY LTD 相关的专利(医药)
100 项与 SpineThera Australia PTY LTD 相关的药物交易
100 项与 SpineThera Australia PTY LTD 相关的转化医学