Discogenic low back pain MedDRA version: 19.0 Level: LLT Classification code 10024891 Term: Low back pain System Organ Class: 100000004859
Conditions
Interventions
Product Code: STA363 (45 mg)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: (S)-Lactic Acid
CAS Number: 79-33-4
Current Sponsor code: (S)-Lactic acid
Other descriptive name: (S)-LACT
Sponsors
Stayble Therapeutics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent prior to any study-related procedures 2. Chronic discogenic low back pain present for more than 6 months prior to the screening visit 3. 20 to 60 years of age at the screening visit 4. Insufficient response to at least 6 months of non-operative treatment (analgesics and/or anti-inflammatory medication, physiotherapy etc.) 5. A single lumbar disc appropriate for treatment at L3/4 to L5/S1, based on clinical evaluation by the investigator 6. Pfirrmann grade II-III 7. Ability to understand the written and verbal information about the study 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 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Treatment with any investigational product within 3 months prior to the screening visit 2. More than one painful intervertebral disc 3. A painful intervertebral disc above L3/4 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. Pfirrmann grade I, IV and V 8. Evidence of prior lumbar vertebral body fracture or trauma 9. Need for spinal decompression assessed by the investigator 10. Presence of disc extrusion or sequestration 11. Patients previously included in the study 12. Patients suffering from psychosomatic pain in the opinion of the investigator 13. Referred leg pain of compressive origin 14. Known alcohol and/or drug abuse 15. Severe intercurrent illness (e.g. rheumatic disease or chronic pain syndrome) or concomitant treatment (e.g. immunosuppressive drugs), which, in the opinion of the investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study 16. Clinically significant abnormalities in clinical chemistry or haematology parameters as assessed by the investigator 17. Pregnant or lactating females, or intention to become pregnant within the study period 18. Known allergy to any of the components of the drug product or placebo 19. Known opioid allergy or intolerance 20. Patients requiring treatment with warfarin or other anticoagulant therapy 21. Unwillingness to refrain from treatment with non-steroidal anti-inflammatory drugs (NSAIDs) within 5 days before the planned study treatment 22. Body weight less than 50 kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess safety and local tolerability of intradiscal injection of STA363 (lactic acid) or placebo.;Secondary Objective: Secondary objective To assess the preliminary efficacy of intradiscal injection of STA363 (lactic acid) or placebo in terms of: ? Transformation of nucleus pulposus into connective tissue by magnetic resonance imaging (MRI) at 12 weeks after injection ? Disc height by MRI before injection and at 12 weeks after injection Exploratory objective To assess: ? VAS pain (leg and back) before and 1, 4 and 12 weeks after injection ? Oswestry Disability Index (ODI) score before and 12 weeks after injection;Primary end point(s): To assess safety and local tolerability of intradiscal injection of STA363 (lactic acid) or placebo by: ? Local injection site reactions ? Frequency and severity of adverse events (AEs) ? Routine safety laboratory parameters ? Visual analogue scale (VAS) pain (injection site) ? Vital signs ? ECG ? Physical examination ? Body weight ? Body weight at Visits 1 and 5;Timepoint(s) of evaluation of this end point: Visit 1: Screening visit, day -30 – -5 Visit 2: Treatment visit, day 0 Visit 3: Week 1, Day 6-9 Visit 4: Telephone follow-up, Week 4, Day 29-32 Visit 5: Week 12, Follow-up visit, Day 89-92 ?Local injection site reactions post-dose at Visit 2 (site visit), Visit 3 (site visit) and Visit 4 (telephone call) ? Frequency and severity of AEs post-dose at Visits 2, 3, 4 and 5 ? Routine safety laboratory parameters at Visits 1, 2, 3 and 5 ? VAS pain (injection site) during and after injection at Visit 2 ? Vital signs (blood pressure and heart rate) at Visits 1, 2 (pre- and post-dose), 3 and 5 ? 12-lead ECG at Visits 1 and 2 (post-dose) ? Physical examinations at Visits 1, 3, and 5 ? Body weight at Visits 1 and 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary objective To assess the preliminary efficacy of intradiscal injection of STA363 (lactic acid) or placebo in terms of: ? Transformation of nucleus pulposus into connective tissue ? Disc height Exploratory objective To assess: ? VAS pain (leg and back) before and after injection ? Oswestry Disability Index (ODI) score before and after injection;Timepoint(s) of evaluation of this end point: Visit 1: Screening visit, day -30 – -5 Visit 2: Treatment visit, day 0 Visit 3: Week 1, Day 6-9 Visit 4: Telephone follow-up, Week 4, Day 29-32 Visit 5: Week 12, Follow-up visit, Day 89-92 Secondary objective ? MRI assessments at Visits 1 and 5 to assess: - Transformation of nucleus pulposus into connective tissue (Pfirrmann grading) by magnetic resonance imaging (MRI) at 12 weeks after injection - Disc height by MRI before injection and at 12 weeks after injection Exploratory objective ? VAS pain (leg) and VAS pain (back) at Visits 1, 3, 4 and 5 ? Oswestry Disability Index (ODI) score at Visits 1 and 5 | — |
Countries
Sweden
Contacts
Public ContactDaniel Seisdedos
PCG Clinical Services AB
Outcome results
None listed