Low Back PainPhase 1NCT03055845
A Single Ascending Dose Study of Safety and Tolerability of STA363 Compared to Placebo in 15 Patients With Chronic Discogenic Low Back Pain
A Phase 1 study testing STA363 in people with Low Back Pain, run by Stayble Therapeutics at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- STA363
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 27 Mar 2017to 29 Aug 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Stockholm Spine Center, Löwenströmska Sjukhuset
Upplands Vasby, 19489
About this study
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
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)
- Conditions
- Low Back Pain
- Being tested
- STA363, Placebo
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STA363Drug
STA363, containing 3 different doses of active ingredient, in a volume of 1.5 mL. Administered as intradiscal injection.
PlaceboDrug
Matching placebo solution with identical appearance to the test product, used as reference treatment. Administered as intradiscal injection.
| Study group | Role | What they receive |
|---|---|---|
| STA363 dose 1 | Experimental | Not described Receives: Drug: STA363 |
| STA363 dose 2 | Experimental | Not described Receives: Drug: STA363 |
| STA363 dose 3 | Experimental | Not described Receives: Drug: STA363 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local injection site reactions
Measured: Up to 4 weeks after injection
Frequency and severity of adverse events
Measured: Up to 12 weeks after injection
Changes in routine safety laboratory parameters
Measured: Up to 12 weeks after injection
Visual analogue scale (VAS) pain (injection site)
Measured: Up to 15 minutes after injection
Changes in vital signs
Measured: Up to 12 weeks after injection
Changes in electrocardiogram (ECG)
Measured: 1 day after injection
Changes in physical examination findings
Measured: 1 and 12 weeks after injection
Changes in body weight
Measured: 12 weeks after injection
Secondary outcomes (2)
Transformation of nucleus pulposus into connective tissue by magnetic resonance imaging (MRI)
Measured: 12 weeks after injection
Disc height by MRI
Measured: 12 weeks after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start27 Mar 2017
- Primary completion29 Aug 2019
- Study completion29 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stayble Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055845
- Sponsor's protocol ID
- STA-01
- Other IDs
- 2015-004812-39, 2015
- Status last verified
- Feb 2020
- First submitted
- 14 Feb 2017
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03055845
- Acronym / sponsor ID
- STA-01
- Conditions
- Low Back Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Stayble TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 29 Aug 2019 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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]).
| Arm | Type | Receives |
|---|---|---|
| STA363 dose 1 | Experimental | Drug: STA363 |
| STA363 dose 2 | Experimental | Drug: STA363 |
| STA363 dose 3 | Experimental | Drug: STA363 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STA363STA363, containing 3 different doses of active ingredient, in a volume of 1.5 mL. Administered as intradiscal injection. | Drug | STA363 dose 1, STA363 dose 2, STA363 dose 3 |
| PlaceboMatching placebo solution with identical appearance to the test product, used as reference treatment. Administered as intradiscal injection. | Drug | Placebo |
Primary outcome
Local injection site reactions
Time frame: Up to 4 weeks after injection
Frequency and severity of adverse events
Time frame: Up to 12 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
2 secondary outcomes
Transformation of nucleus pulposus into connective tissue by magnetic resonance imaging (MRI)
Time frame: 12 weeks after injection
Disc height by MRI
Time frame: 12 weeks after injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing STA363 in people with Low Back Pain, run by Stayble Therapeutics at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local injection site reactions (time frame: Up to 4 weeks after injection). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.