This is a phase IIb, prospective, multi-country, multicenter, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and transformation of NP following single intradiscal injection of STA363 (lactic acid) into one or two IVDs compared to placebo for the treatment of discogenic low back pain. This study will be conducted in Russia, Spain and the Netherlands.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Signed informed consent prior to any study related procedures.
✓. Male and female patients ≥18 and ≤70 years.
✓. Chronic discogenic low back pain present for more than 6 months prior to the screening visit.
✓. Insufficient response or lack of response to at least 6 months of non-operative treatment (analgesics and/or anti-inflammatory medications \[paracetamol, non-steroidal anti-inflammatory agents (NSAIDs), opioids\], physiotherapy, rehabilitation therapy etc.).
✓. Patients who meet all the following NRS selection criteria:
✓. Presence of ≥5 pain NRS assessments (entries) for 7 consecutive days.
✓. NRS daily pain scores between 3-9.
✓. Not more than two ratings "3".
Exclusion criteria
✕. Treatment with any investigational product within 3 months prior to the screening visit.
✕. 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.
What they're measuring
1
Pain intensity at 6 months on a Numerical rating scale