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Study Investigating STA363 Compared to Placebo in Patients With Chronic Discogenic Low Back Pain

CompletedPhase 2NCT04673461
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
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
Conditions
  • Discogenic Pain
Interventions
  • Drug: STA363 containing 90 mg (60 mg/mL) lactic acid
  • Drug: STA363 containing 180 mg (120 mg/mL) lactic acid
  • Drug: Placebo
Sponsor
Stayble Therapeutics
Start date
2020-07-31
Primary completion
2023-09-01
Sex
All
Age range
from 18 Years to 70 Years
Results posted
No results posted in this snapshot
Countries
Netherlands, Russia, Spain
Total sites listed
17

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Signed informed consent prior to any study related procedures. 2. Male and female patients ≥18 and ≤70 years. 3. Chronic discogenic low back pain present for more than 6 months prior to the screening visit. 4. 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.). 5. Patients who meet all the following NRS selection criteria: 1. Presence of ≥5 pain NRS assessments (entries) for 7 consecutive days. 2. NRS daily pain scores between 3-9. 3. Not more than two ratings "3". 6. 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: 1. 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). 2. Patients with treatable IVD(s) of grade 2 must have all other lumbar discs rated as grade 1. 3. Not more than two IVDs of grade 3 at any lumbar level. 4. No IVDs of grade 4 or 5 at any lumbar level. 7. Ability to understand the written and verbal information about the study. Exclusion Criteria: 1. Treatment with any investigational product within 3 months prior to the screening visit. 2. Patients with more than two painful IVDs. 3. A painful IVD above L2/3 level. 4. Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection. 5. Previous lumbar spine surgery. 6. Previous disc invasive treatment procedures at the affected level(s) (e.g., intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation). 7. Evidence of prior lumbar vertebral body fracture or trauma. 8. Need for spinal decompression assessed by the Investigator. 9. Presence of IVD extrusion or sequestration, or other radiologic findings that in the opinion of the investigator disqualify the patient from being included. 10. Spondylolisthesis or retrolisthesis Grade 2 and above or spondylolysis at the index or adjacent level(s). 11. Lumbar spondylitis or other undifferentiated spondyloarthropathy affecting the index IVD. 12. Patients previously included in the study. 13. Patients suffering from psychosomatic pain in the opinion of the Investigator…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04673461