A Prospective, Randomised, Double-blinded, Placebo-controlled, Single Ascending Dose Study Investigating the Safety and Local Tolerability of STA363 Compared to Placebo in 15 Patients With Chronic Discogenic Low Back Pain
Overview
- Phase
- Phase 1
- Intervention
- STA363
- Conditions
- Low Back Pain
- Sponsor
- Stayble Therapeutics
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Local injection site reactions
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
A phase I, randomized, double-blinded, placebo-controlled, single ascending dose study to investigate the safety, local tolerability and transformation of nucleus pulposus following intradiscal injection of STA363 or placebo in patients with discogenic low back pain.
15 patients will participate in either of 3 dose groups, each comprising 5 patients:
- Group 1: STA363 dose 1 (3 patients) or placebo (2 patients)
- Group 2: STA363 dose 2 (3 patients) or placebo (2 patients)
- Group 3: STA363 dose 3 (3 patients) or placebo (2 patients)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent prior to any study-related procedures
- •Chronic discogenic low back pain present for more than 6 months prior to the screening visit
- •20 to 60 years of age at the screening visit
- •Insufficient response to at least 6 months of non-operative treatment (analgesics and/or antiinflammatory medication, physiotherapy etc.)
- •A single lumbar disc appropriate for treatment at L3/4 to L5/S1, based on clinical evaluation by the investigator
- •Pfirrmann grade II-III
- •Ability to understand the written and verbal information about the study
Exclusion Criteria
- •Treatment with any investigational product within 3 months prior to the screening visit
- •More than one painful intervertebral disc
- •A painful intervertebral disc above L3/4 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)
- •Pfirrmann grade I, IV and V
- •Evidence of prior lumbar vertebral body fracture or trauma
- •Need for spinal decompression assessed by the investigator
- •Presence of disc extrusion or sequestration
Arms & Interventions
STA363 dose 1
Intervention: STA363
STA363 dose 2
Intervention: STA363
STA363 dose 3
Intervention: STA363
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Local injection site reactions
Time Frame: Up to 4 weeks after injection
Changes in routine safety laboratory parameters
Time Frame: Up to 12 weeks after injection
Visual analogue scale (VAS) pain (injection site)
Time Frame: Up to 15 minutes after injection
Changes in vital signs
Time Frame: Up to 12 weeks after injection
Changes in electrocardiogram (ECG)
Time Frame: 1 day after injection
Changes in physical examination findings
Time Frame: 1 and 12 weeks after injection
Changes in body weight
Time Frame: 12 weeks after injection
Frequency and severity of adverse events
Time Frame: Up to 12 weeks after injection
Secondary Outcomes
- Transformation of nucleus pulposus into connective tissue by magnetic resonance imaging (MRI)(12 weeks after injection)
- Disc height by MRI(12 weeks after injection)