A multi-country, randomized, double-blind, placebo-controlled study investigating the efficacy and safety of STA363 at two concentrations (60 mg/mL and 120 mg/mL) compared to placebo in patients with chronic discogenic low back pain

Stayble Therapeutics AB0 个研究点目标入组 126 人开始时间: 2020年5月10日最近更新: 2023年10月16日

适应症

试验速览

暂无简介。

•One or two treatable IVDs of Pfirrmann grade 2 to 3 on MRI at L2/3 to L5/S1 as confirmed by a central reader, AND the following criteria are met:
•a.Treatable IVD(s) must be IVD(s) with the highest Pfirrmann grade observed in the patient (e.g. a patient with one IVD of grade 3 and four IVDs of grade 2 is considered eligible only if IVD of grade 3 will be injected).
•b.Patients with treatable IVD(s) of grade 2 must have all other lumbar discs rated as grade 1.
•c.Not more than two IVDs of grade 3 at any lumbar level.
•d.No IVDs of grade 4 or 5 at any lumbar level.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 6

•Patients with more than two painful IVDs
•A painful IVD above L2/3 level.
•Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection.
•Previous lumbar spine surgery.
•Previous disc invasive treatment procedures at the affected level(s) (e.g., intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation).
•Evidence of prior lumbar vertebral body fracture or trauma.
•Need for spinal decompression assessed by the Investigator.
•Presence of IVD extrusion or sequestration.
•Spondylolisthesis or retrolisthesis Grade 2 and above or spondylolysis at the index or adjacent level(s).
•Lumbar spondylitis or other undifferentiated spondyloarthropathy affecting the index IVD.
•Patients suffering from psychosomatic pain in the opinion of the Investigator.
•Leg pain of compressive origin.

发起方