Back to resultsA Single Ascending Dose Study of Safety and Tolerability of STA363 Compared to Placebo in 15 Patients With Chronic Discogenic Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
STA363
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
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
- Patients previously included in the study
- Patients suffering from psychosomatic pain in the opinion of the investigator
- Referred leg pain of compressive origin
- Known alcohol and/or drug abuse
- 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
- Clinically significant abnormalities in clinical chemistry or haematology parameters as assessed by the investigator
- Pregnant or lactating females or intention to become pregnant within the study period
- Known allergy to any of the components of the drug product or placebo
- Known opioid allergy or intolerance
- Patients requiring treatment with warfarin or other anticoagulant therapy
- Unwillingness to refrain from treatment with non-steroidal anti-inflammatory drugs (NSAIDs) within 5 days before the planned study treatment
- Body weight less than 50 kg
Sites / Locations
- Stockholm Spine Center, Löwenströmska Sjukhuset
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
STA363 dose 1
STA363 dose 2
STA363 dose 3
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Local injection site reactions
Frequency and severity of adverse events
Changes in routine safety laboratory parameters
Visual analogue scale (VAS) pain (injection site)
Changes in vital signs
Changes in electrocardiogram (ECG)
Changes in physical examination findings
Changes in body weight
Secondary Outcome Measures
Transformation of nucleus pulposus into connective tissue by magnetic resonance imaging (MRI)
Disc height by MRI
Full Information
NCT ID
NCT03055845
First Posted
February 14, 2017
Last Updated
February 17, 2020
Sponsor
Stayble Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT03055845
Brief Title
A Single Ascending Dose Study of Safety and Tolerability of STA363 Compared to Placebo in 15 Patients With Chronic Discogenic Low Back Pain
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 27, 2017 (Actual)
Primary Completion Date
August 29, 2019 (Actual)
Study Completion Date
August 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stayble Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Following treatment of 2 patients in each dose group (injections with active drug and placebo, respectively), safety data will be reviewed. If no safety or tolerability concerns are identified, the next 3 patients in each dose group will be treated (active treatment or placebo [2:1]).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STA363 dose 1
Arm Type
Experimental
Arm Title
STA363 dose 2
Arm Type
Experimental
Arm Title
STA363 dose 3
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
STA363
Intervention Description
STA363, containing 3 different doses of active ingredient, in a volume of 1.5 mL. Administered as intradiscal injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo solution with identical appearance to the test product, used as reference treatment. Administered as intradiscal injection.
Primary Outcome Measure Information:
Title
Local injection site reactions
Time Frame
Up to 4 weeks after injection
Title
Frequency and severity of adverse events
Time Frame
Up to 12 weeks after injection
Title
Changes in routine safety laboratory parameters
Time Frame
Up to 12 weeks after injection
Title
Visual analogue scale (VAS) pain (injection site)
Time Frame
Up to 15 minutes after injection
Title
Changes in vital signs
Time Frame
Up to 12 weeks after injection
Title
Changes in electrocardiogram (ECG)
Time Frame
1 day after injection
Title
Changes in physical examination findings
Time Frame
1 and 12 weeks after injection
Title
Changes in body weight
Time Frame
12 weeks after injection
Secondary Outcome Measure Information:
Title
Transformation of nucleus pulposus into connective tissue by magnetic resonance imaging (MRI)
Time Frame
12 weeks after injection
Title
Disc height by MRI
Time Frame
12 weeks after injection
Other Pre-specified Outcome Measures:
Title
VAS pain (leg and back)
Time Frame
1, 4 and 12 weeks after injection
Title
Oswestry disability index (ODI) score
Time Frame
12 weeks after injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Patients previously included in the study
Patients suffering from psychosomatic pain in the opinion of the investigator
Referred leg pain of compressive origin
Known alcohol and/or drug abuse
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
Clinically significant abnormalities in clinical chemistry or haematology parameters as assessed by the investigator
Pregnant or lactating females or intention to become pregnant within the study period
Known allergy to any of the components of the drug product or placebo
Known opioid allergy or intolerance
Patients requiring treatment with warfarin or other anticoagulant therapy
Unwillingness to refrain from treatment with non-steroidal anti-inflammatory drugs (NSAIDs) within 5 days before the planned study treatment
Body weight less than 50 kg
Facility Information:
Facility Name
Stockholm Spine Center, Löwenströmska Sjukhuset
City
Upplands Väsby
ZIP/Postal Code
19489
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
A Single Ascending Dose Study of Safety and Tolerability of STA363 Compared to Placebo in 15 Patients With Chronic Discogenic Low Back Pain
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