SpondyloarthritisPhase 3SKIPPAINNCT03136861
SKIPPAIN - Speed of Onset of SecuKinumab-Induced Relief From Pain in Patients With AxIal SpoNdyloarthritis
A Phase 3 study testing AIN457 in people with Spondyloarthritis, run by Novartis Pharmaceuticals at 66 sites in 17 countries.
Trial summary
The purpose of the study was to evaluate the efficacy and safety of secukinumab 150 mg compared to placebo in the early management (Baseline to Week 8) of spinal pain, disease activity, fatigue, and predictability of disease flares in patients with axial spondyloarthritis (axSpA) who had an inadequate response to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthritis
- What is being tested?
- AIN457
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 383 participants
- Where
- 66 sitesin 17 countries
- Study dates
- 30 Jun 2017to 15 Feb 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of axial spondylarthritis (axSpA, either ankylosing spondylitis or non radiographic axial spondylarthritis) according to ASAS axSpA classification criteria
- patients with back pain for at least 3 months and age of onset less than 45 years
- Active axSpA as assessed by total BASDAI score of at least 4 at Baseline.
- Spinal pain numeric rating scale score of more than 4 at Baseline.
- inadequate response to or failure to respond to at least 2 different NSAIDs at the highest recommended dose for at least 4 weeks in total prior to randomization
Who cannot join
- Chest X-ray or MRI with evidence of ongoing infectious or malignant process
- Patients previously treated with any biological immunomodulating agents, except those targeting tumor necrosis factor alpha.
- Patients who have been exposed to more than one anti-tumor necrosis factor alpha agent.
- Active ongoing inflammatory diseases other than axial spondyloarthritis
- Other ongoing mechanical diseases affecting the spine.
Trial locations and contacts
66 sites in 17 countries.
66 sites in 17 countries
Spain14 sites
Novartis Investigative Site
Barcelona, 08041
Novartis Investigative Site
Elche, Alicante, 03203
Novartis Investigative Site
Elda, Alicante, 03600
Novartis Investigative Site
Galdakao, Bizkaia
Novartis Investigative Site
Lugo, Galicia, 27003
Novartis Investigative Site
Mallorca, Balearic Islands, 07198
Novartis Investigative Site
Ourense, Galicia, 32005
Novartis Investigative Site
Plasencia, Extremadura, 10600
Novartis Investigative Site
Seville, Andalusia, 41009
Novartis Investigative Site
Seville, Andalusia, 41013
Novartis Investigative Site
Torrejón de Ardoz, Madrid, 28850
Novartis Investigative Site
Torrelavega, Cantabria, 39300
Novartis Investigative Site
Valencia, Valencia, 46010
Novartis Investigative Site
Valencia, Valencia, 46014
Poland7 sites
Novartis Investigative Site
Bydgoszcz, 85 168
Novartis Investigative Site
Sopot, 81 756
Novartis Investigative Site
Torun, 87-100
Novartis Investigative Site
Warsaw, Mazowian, 02 495
Novartis Investigative Site
Warsaw, 00-874
Novartis Investigative Site
Warsaw, 04 305
Novartis Investigative Site
Wroclaw, 53-224
Bulgaria5 sites
Novartis Investigative Site
Burgas, 8000
Novartis Investigative Site
Plovdiv, 4000
Novartis Investigative Site
Sofia, 1413
Novartis Investigative Site
Sofia, 1505
Novartis Investigative Site
Sofia, 1750
Greece5 sites
Novartis Investigative Site
Alexandroupoli, Evros, 681 00
Novartis Investigative Site
Athens, 115 27
Novartis Investigative Site
Athens, 145 61
Novartis Investigative Site
Thessaloniki, GR, 564 29
Novartis Investigative Site
Thessaloniki, 54636
United Kingdom5 sites
Novartis Investigative Site
Liverpool, L9 7AL
Novartis Investigative Site
Plymouth, PL6 8DH
Novartis Investigative Site
Stoke-on-Trent, Staffordshire, ST6 7AG
Novartis Investigative Site
Warrington, WA5 1QG
Novartis Investigative Site
Wolverhampton, WV10 0QP
Russia4 sites
Novartis Investigative Site
Irkutsk, 664046
Novartis Investigative Site
Izhevsk, 426009
Novartis Investigative Site
Kazan', 420097
Novartis Investigative Site
Moscow, 115093
Sweden4 sites
Novartis Investigative Site
Danderyd, 182 88
Novartis Investigative Site
Halmstad, SE 302 66
Novartis Investigative Site
Härnösand, SE 871 31
Novartis Investigative Site
Stockholm, SE, 113 65
Croatia3 sites
Novartis Investigative Site
Rijeka, 51000
Novartis Investigative Site
Zagreb, HRV, 10000
Novartis Investigative Site
Zagreb, 10000
Czechia3 sites
Novartis Investigative Site
Brno, 63800
Novartis Investigative Site
Plzen-Bory, 30599
Novartis Investigative Site
Prague, 150 06
Estonia3 sites
Novartis Investigative Site
Pärnu, 80010
Novartis Investigative Site
Tallinn, 10138
Novartis Investigative Site
Tartu, 50406
Latvia3 sites
Novartis Investigative Site
Liepāja, LV 3401
Novartis Investigative Site
Riga, LV 1002
Novartis Investigative Site
Riga, LV 2164
Belgium2 sites
Novartis Investigative Site
Brussels, 1020
Novartis Investigative Site
Liège, 4000
Finland2 sites
Novartis Investigative Site
Kuopio, 70100
Novartis Investigative Site
Kuovola, 45100
Ireland2 sites
Novartis Investigative Site
Dublin, D03 VX82
Novartis Investigative Site
Dublin, D04 T6F
Lithuania2 sites
Novartis Investigative Site
Kaunas, LTU, LT 50161
Novartis Investigative Site
Kaunas, LT, LT-50128
About this study
Official title: A 24-week, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Secukinumab in Controlling Spinal Pain in Patients With Axial Spondyloarthritis
The purpose of the study was to evaluate the efficacy and safety of secukinumab 150 mg compared to placebo in the early management (Baseline to Week 8) of spinal pain, disease activity, fatigue, and predictability of disease flares in patients with axial spondyloarthritis (axSpA) who had an inadequate response to prior non-steroidal anti-inflammatory drugs (NSAIDs). This study also explored the efficacy and safety of secukinumab 300 mg compared to secukinumab 150 mg from Week 8 to Week 24 in order to assess the potential additional benefits of dose escalation in patients with axSpA.
Read the detailed description
The study consisted of 2 treatment periods: a double-blind, placebo-controlled period from Baseline to Week 8 (Treatment Period 1) and a double-blind secukinumab treatment period from Week 8 to Week 24 (Treatment Period 2).
At Baseline (Treatment Period 1), patients were randomized in a 3:1 ratio to either secukinumab 150 mg (Group A) or placebo (Group B). At Week 8 (Treatment Period 2), patients were re-randomized and re-assigned respectively to 1 of 5 treatment arms to receive either secukinumab 150 mg or secukinumab 300 mg.
Patients assigned to secukinumab 150 mg (Group A) at Baseline who were responders (i.e. spinal pain score < 4) at Week 8 continued on the same dose until Week 24 under 1 treatment arm (Arm A1). Patients assigned to secukinumab 150 mg at Baseline who were non-responders at Week 8 were re-randomized to 1 of 2 treatment arms: secukinumab 150 mg (Arm A2) or secukinumab 300 mg (Arm A3) from Week 8 to Week 24.
Similarly, patients assigned to placebo (Group B) at Baseline were re-randomized to 1 of 2 treatment arms: secukinumab 150 mg (Arm B1) or secukinumab 300 mg (Arm B2) from Week 8 until Week 24.
- Conditions
- Spondyloarthritis
- Being tested
- AIN457, AIN457 Placebo
- Keywords
- axial spondyloarthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, inflammatory back pain, spinal pain, secukinumab, AIN457
- Medical subject headings
- Spondylarthritis, Axial Spondyloarthritis, Spondylitis, Ankylosing, Non-Radiographic Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIN457Biological
Also called secukinumab
anti IL-17a monoclonal antibody
AIN457 PlaceboDrug
Also called Placebo
Placebo matching AIN457
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab 150 mg (Group A) | Experimental | Treatment Period 1: Secukinumab 150 mg (1 x 1.0 mL) s.c. administered at Baseline, Week 1, 2, 3 and 4 Receives: Biological: AIN457 |
| Placebo (Group B) | Placebo comparator | Treatment Period 1: Placebo (1 x 1.0 mL) s.c. administered at Baseline and Week 1, 2, 3 and 4 Receives: Biological: AIN457; Drug: AIN457 Placebo |
| Arm A1 | Active comparator | Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20 Receives: Biological: AIN457; Drug: AIN457 Placebo |
| Arm A2 | Active comparator | Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20 Receives: Biological: AIN457; Drug: AIN457 Placebo |
| Arm A3 | Active comparator | Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20 Receives: Biological: AIN457 |
| Arm B1 | Active comparator | Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20 Receives: Biological: AIN457; Drug: AIN457 Placebo |
| Arm B2 | Active comparator | Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20 Receives: Biological: AIN457 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Spinal Pain Numerical Rating Scale (NRS) Score Below 4 at Week 8 (Treatment Period 1)
The spinal pain numerical rating scale (NRS) is an 11-point scale to assess pain intensity in patients who are able to self-report. It is an 11-point scale from 0-10: 1) "0" = no pain. 2) "10" = the most intense pain imaginable. To calculate the average spinal pain, the patient was asked to answer 2 questions to get 2 pain ratings, the total spinal pain corresponding to the intensity of spinal pain experienced on an average over 24 hours during the previous week and the nocturnal back pain corresponding to the intensity of spinal pain experienced on an average over the night during the previous week.
Measured: Week 8
Secondary outcomes (1)
Percentage of Participants With a Bath Ankylosing Spondylitis Disease Activity Index Score Below 4 at Week 8 (Treatment Period 1)
The Bath ankylosing spondylitis disease activity index (BASDAI) consists of a 0 through 10 scale, which is used to answer 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis. To give each symptom equal weighting, the mean (average) of the 2 scores relating to morning stiffness (questions 5 and 6) is taken. The mean of questions 5 and 6 is added to the scores from questions 1-4. The resulting 0 to 50 score is divided by 5 to give a final 0 - 10 BASDAI score.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start30 Jun 2017
- Primary completion15 Feb 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136861
- Sponsor's protocol ID
- CAIN457H3301
- Other IDs
- 2017-000401-21, 2017
- Acronym
- SKIPPAIN
- Status last verified
- Aug 2021
- First submitted
- 28 Apr 2017
- Last updated
- 5 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is commited to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
Publications
Poddubnyy D, Pournara E, Zielinska A, Baranauskaite A, Jimenez AM, Sadhu S, Schulz B, Rissler M, Perella C, Marzo-Ortega H. Rapid improvement in spinal pain in patients with axial spondyloarthritis treated with secukinumab: primary results from a randomized controlled phase-IIIb trial. Ther Adv Musculoskelet Dis. 2021 Oct 22;13:1759720X211051471. doi: 10.1177/1759720X211051471. eCollection 2021.
PubMed 34707696
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Secukinumab in Controlling Spinal Pain in Patients With Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT03136861
- Acronym / sponsor ID
- SKIPPAIN / CAIN457H3301
- Conditions
- Spondyloarthritis
- Keywords
- axial spondyloarthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, inflammatory back pain, spinal pain, secukinumab, AIN457
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 383 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Posted 19 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study was to evaluate the efficacy and safety of secukinumab 150 mg compared to placebo in the early management (Baseline to Week 8) of spinal pain, disease activity, fatigue, and predictability of disease flares in patients with axial spondyloarthritis (axSpA) who had an inadequate response to prior non-steroidal anti-inflammatory drugs (NSAIDs). This study also explored the efficacy and safety of secukinumab 300 mg compared to secukinumab 150 mg from Week 8 to Week 24 in order to assess the potential additional benefits of dose escalation in patients with axSpA.
Detailed description
The study consisted of 2 treatment periods: a double-blind, placebo-controlled period from Baseline to Week 8 (Treatment Period 1) and a double-blind secukinumab treatment period from Week 8 to Week 24 (Treatment Period 2).
At Baseline (Treatment Period 1), patients were randomized in a 3:1 ratio to either secukinumab 150 mg (Group A) or placebo (Group B). At Week 8 (Treatment Period 2), patients were re-randomized and re-assigned respectively to 1 of 5 treatment arms to receive either secukinumab 150 mg or secukinumab 300 mg.
Patients assigned to secukinumab 150 mg (Group A) at Baseline who were responders (i.e. spinal pain score < 4) at Week 8 continued on the same dose until Week 24 under 1 treatment arm (Arm A1). Patients assigned to secukinumab 150 mg at Baseline who were non-responders at Week 8 were re-randomized to 1 of 2 treatment arms: secukinumab 150 mg (Arm A2) or secukinumab 300 mg (Arm A3) from Week 8 to Week 24.
Similarly, patients assigned to placebo (Group B) at Baseline were re-randomized to 1 of 2 treatment arms: secukinumab 150 mg (Arm B1) or secukinumab 300 mg (Arm B2) from Week 8 until Week 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Secukinumab 150 mg (Group A) | Experimental | Biological: AIN457Treatment Period 1: Secukinumab 150 mg (1 x 1.0 mL) s.c. administered at Baseline, Week 1, 2, 3 and 4 |
| Placebo (Group B) | Placebo comparator | Biological: AIN457, Drug: AIN457 PlaceboTreatment Period 1: Placebo (1 x 1.0 mL) s.c. administered at Baseline and Week 1, 2, 3 and 4 |
| Arm A1 | Active comparator | Biological: AIN457, Drug: AIN457 PlaceboTreatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20 |
| Arm A2 | Active comparator | Biological: AIN457, Drug: AIN457 PlaceboTreatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20 |
| Arm A3 | Active comparator | Biological: AIN457Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20 |
| Arm B1 | Active comparator | Biological: AIN457, Drug: AIN457 PlaceboTreatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20 |
| Arm B2 | Active comparator | Biological: AIN457Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of axial spondylarthritis (axSpA, either ankylosing spondylitis or non radiographic axial spondylarthritis) according to ASAS axSpA classification criteria
- patients with back pain for at least 3 months and age of onset less than 45 years
- Active axSpA as assessed by total BASDAI score of at least 4 at Baseline.
- Spinal pain numeric rating scale score of more than 4 at Baseline.
- inadequate response to or failure to respond to at least 2 different NSAIDs at the highest recommended dose for at least 4 weeks in total prior to randomization
Key exclusion criteria (5 listed)
- Chest X-ray or MRI with evidence of ongoing infectious or malignant process
- Patients previously treated with any biological immunomodulating agents, except those targeting tumor necrosis factor alpha.
- Patients who have been exposed to more than one anti-tumor necrosis factor alpha agent.
- Active ongoing inflammatory diseases other than axial spondyloarthritis
- Other ongoing mechanical diseases affecting the spine.
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 |
|---|---|---|
| AIN457Also: secukinumabanti IL-17a monoclonal antibody | Biological | Arm A1, Arm A2, Arm A3, Arm B1, Arm B2, Placebo (Group B), Secukinumab 150 mg (Group A) |
| AIN457 PlaceboAlso: PlaceboPlacebo matching AIN457 | Drug | Arm A1, Arm A2, Arm B1, Placebo (Group B) |
Primary outcome
Percentage of Participants With a Spinal Pain Numerical Rating Scale (NRS) Score Below 4 at Week 8 (Treatment Period 1)
Time frame: Week 8
The spinal pain numerical rating scale (NRS) is an 11-point scale to assess pain intensity in patients who are able to self-report. It is an 11-point scale from 0-10: 1) "0" = no pain. 2) "10" = the most intense pain imaginable. To calculate the average spinal pain, the patient was asked to answer 2 questions to get 2 pain ratings, the total spinal pain corresponding to the intensity of spinal pain experienced on an average over 24 hours during the previous week and the nocturnal back pain corresponding to the intensity of spinal pain experienced on an average over the night during the previous week.
1 secondary outcome
Percentage of Participants With a Bath Ankylosing Spondylitis Disease Activity Index Score Below 4 at Week 8 (Treatment Period 1)
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34707696Poddubnyy D, Pournara E, Zielinska A, Baranauskaite A, Jimenez AM, Sadhu S, Schulz B, Rissler M, Perella C, Marzo-Ortega H. Rapid improvement in spinal pain in patients with axial spondyloarthritis treated with secukinumab: primary results from a randomized controlled phase-IIIb trial. Ther Adv Musculoskelet Dis. 2021 Oct 22;13:1759720X211051471. doi: 10.1177/1759720X211051471. eCollection 2021.
- A Plain Language Trial Summary is available on novartisclinicatrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is commited to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
66 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AIN457 in people with Spondyloarthritis, run by Novartis Pharmaceuticals at 66 sites in 17 countries.
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 5 inclusion and 5 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 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in Spain, Poland, Bulgaria, Greece, United Kingdom and 12 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With a Spinal Pain Numerical Rating Scale (NRS) Score Below 4 at Week 8 (Treatment Period 1) (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03136861, which also lists 1 linked publication.
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 5 Sep 2021.