Investigating the safety and local tolerability of STA363 compared to placebo in 15 patients with chronic discogenic low back pai

Phase 1

• Conditions: Discogenic low back pain; MedDRA version: 19.0Level: LLTClassification code 10024891Term: Low back painSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2015-004812-39-SE
• Lead Sponsor: Stayble Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-15
• Last Update Posted: 23 January 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified