Low Back PainCOLOMBNCT04826757
Effectiveness of Coordinated Care to Reduce the Prolonged Disability Risk Among Patients Suffering From Low Back Pain in Primary Care
A study testing Coordinated care in people with Low Back Pain, run by University Hospital, Angers at 20 sites in France.
Trial summary
Common low back pain affects about 23% of general population and can be associated with psychosocial difficulties and prolonged inability to work. Its management in France mainly depends on general practioners, and sometime on physiotherapists. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Coordinated care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 20 sitesFrance
- Study dates
- 21 Sep 2022to 22 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient consulting an investigator GP for subacute low back pain or acute recurrent low back pain
- Patient with occupational activity (including sick leave)
- Patient depending of occupational health service
- Obtaining the signature of the consent to participate in this trial
- Patient Registered with social security scheme
- Non-inclusion Criteria:
Show all 19Show fewer
- Specific low back pain (fracture, infection, osteoporosis, inflammatory disease, tumor)
- Low back pain with sciatic, cruralgia
- Contraindication to active reeducation
- Impossibility to follow up during 12 months
- Patient planning to retire within the 12 months following the enrollment
- Disability to write or read french
- Adult patient protected under the law (guardianship),
- Pregnant, breastfeeding or parturient women
- Persons deprived of their liberty by judicial or administrative decision
- Persons subject to legal protection measures
- Persons unable to consent
- Persons on coercion psychiatric care
- Physiotherapy by a physiotherapist who don't participate in this trial
Who cannot join
None listed.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
Cluster Bonchamp
Bonchamp-lès-Laval
Cluster Vaunoise
Breteil
Cluster BRULON
Brûlon
Cluster Château Gontier
Château-Gontier
Cluster Châteauneuf sur Sarthe / Morannes
Châteauneuf-sur-Sarthe
Cluster Clisson
Clisson
Cluster Conlie
Conlie
Cluster Craon Renaze Cosse
Craon
Cluster Entrammes Laval
Entrammes
Cluster Roche sur Yon
La Roche-sur-Yon
Cluster Chantenay
Nantes
Cluster Dinan / Quévert / Plouasne
Quévert
Cluster Rennes Beauregard
Rennes
Cluster Rennes Villejean
Rennes
Cluster Les Collines
Roquefort-les-Pins
Cluster St Florent, Mauges, Possonnière
Saint-Florent-le-Vieil
Cluster Savenay
Savenay
Cluster SEGRE
Segré
Cluster Angers- Trélazé
Trélazé
Cluster Vence
Vence
About this study
Official title: Effectiveness of Coordinated Care to Reduce the Risk of Prolonged Disability Among Patients Suffer From Subacute or Recurrent Acute Low Back Pain in Primary Care
Common low back pain affects about 23% of general population and can be associated with psychosocial difficulties and prolonged inability to work. Its management in France mainly depends on general practioners, and sometime on physiotherapists.
A coordinated care between general practioners, physiotherapists and occupational health services would help to improve the care pathway for patients and health professionals.
The main objective is to assess the impact of coordinated primary care and deployed at the territories' level, in subacute or acute recurrent low back pain patients in comparison with the standard care.
- Conditions
- Low Back Pain
- Being tested
- Coordinated care
- 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.
Coordinated careOther
Coordinated care between general practioners; physiotherapists and occupational health services.
Early contact with occupational health service by the general practioner and use of occupational retention tool Active physiotherapy (Individual active, intensive and regular rehabilitation program with 15 sessions of 1 hour, at a rate of 2 or 3 sessions per week)
| Study group | Role | What they receive |
|---|---|---|
| standard care | No intervention | standard care for low back pain management by general practioners (GPs). the physiotherapist and occupational health services can be solicited independently by the patient or GP. |
| coordinated care | Experimental | Coordinated care between general practioners, physiotherapist and occupational health services.
An intervention training will be performed before the start of the study for any care professional's to elaborate coordination tools and have an active communication. Receives: Other: Coordinated care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived inability at 1 year
Ratio of patient presenting improvement equal or above 4 points of Roland Morris Disability Questionnaire. The minimum value of Roland Morris Disability Questionnaire is 0 and the maximun value is 24. A higher score mean worse outcome
Measured: Enrollment to 12 months follow up
Secondary outcomes (25)
Perceived inability
Ratio of patient presenting improvement equal or above 4 points of Roland Morris Disability Questionnaire. The minimum value of Roland Morris Disability Questionnaire is 0 and the maximun value is 24. A higher score mean worse outcome
Measured: Enrollment to 3 months follow up, Enrollment to 6 months follow up
Roland Morris Disability score over time
Evolution of Roland Morris Disability Questionnaire over time. The minimum value is 0 and the maximun value is 24. A higher score mean worse outcome
Measured: Enrollment, 3 months, 6 months, 12 months
Pain perceived
Ratio of patients presenting improvement equal or above 2 points of numerical pain scale The minimum value is 0 and the maximun value is 10. A higher score mean worse outcome
Measured: Enrollment - 3 months , Enrollment - 6 months and Enrollment -12 months
Numerical pain scale over time
Evolution of numerical pain scale over time. The minimum value is 0 and the maximun value is 10. A higher score mean worse outcome
Measured: Enrollment, 3 months, 6 months, 12 months
Occupational status
Ratio of patients having an active occupation (defined by have an employment and be present at work )
Measured: at 3 months, 6 months and 12 months
Employment rate
Evolution of employment rate over time
Measured: Enrollment, 3 months, 6 months, 12 months
Sick leave
number of sick leave days
Measured: during 12 months after inclusion
Improved patients
Ratio of improved patients. Improved patients is defined by patient presenting improvement equal or above 4 points of Roland Morris Disability Questionnaire and improvement equal or above 2 points of numerical pain scale and having a active occupational
Measured: at 3 months, 6 months and 12 months
Evolution of improved patients ratio
Evolution of improved patients ratio over time Improved patients is defined by patient presenting improvement equal or above 4 points of Roland Morris Disability Questionnaire and improvement equal or above 2 points of numerical pain scale and having a active occupational
Measured: Enrollment, 3 months, 6 months, 12 months
Mental component score of Short Form -12
Evolution of mental scores over time The mental component score is determined by 4 categories of Short Form -12. The minimum value of each category is 0 and the maximun value is 100. A higher score mean better outcome
Measured: Enrollment, 3 months, 6 months, 12 months
Physical component score of Short Form -12
Evolution of physical scores over time. The physical component score is determined by 4 categories of Short Form -12. The minimum value of each category is 0 and the maximun value is 100. A higher score mean better outcome
Measured: Enrollment, 3 months, 6 months, 12 months
Occupational component score of Fear Avoidance Beliefs Questionnaire
Evolution of occupational component score over time. Occupational component is assessed using the Fear Avoidance Beliefs Questionnaire.
The minimum value is 0 and the maximun value is 42. A higher score mean worse outcome
Measured: Enrollment, 3 months, 12 months
Physical activity component score of Fear Avoidance Beliefs Questionnaire
Evolution of physical activity component score over time. Physical activity component is assessed using the Fear Avoidance Beliefs Questionnaire.
The minimum value is 0 and the maximun value is 24. A higher score mean worse outcome
Measured: Enrollment, 3 months, 12 months
Anxiety component score of Hospital Anxiety and Depression Scale
Evolution of Anxiety score over time Anxiety Component is assessed using the Hospital Anxiety and Depression Scale The minimum value is 0 and the maximun value is 21. A higher score mean worse outcome
Measured: Enrollment 3 months, 12 months
Depression component score of Hospital Anxiety and Depression Scale
Evolution of Depression score over time Depression component is assessed using the Hospital Anxiety and Depression Scale The minimum value is 0 and the maximun value is 21. A higher score mean worse outcome
Measured: Enrollment, 3 months, 12 months
Coordination care score of Patient Centered Coordination by a Care Team questionnaire
Evolution of coordination care score over time This score is assessed by using Patient Centered Coordination by a Care Team questionnaire.
The minimum value is 0 and the maximun value is 42. A higher score mean better outcome
Measured: Enrollment, 3 months, 12 months
GP satisfaction related to patient care
Evolution of GP satisfaction using an numerical scale The minimum value is 0 and the maximun value is 10. A higher score mean worse outcome
Measured: T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion)
Physiotherapist satisfaction related to patient care
Evolution of physiotherapist satisfaction using an numerical scale The minimum value is 0 and the maximun value is 10. A higher score mean worse outcome
Measured: T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion)
Professionals trained for intervention
number of professionals trained for intervention
Measured: Baseline intervention formations
Biomechanical component score of Pain Attitudes and Beliefs score - for intervention physiotherapists
Evolution of Biomechanical component score for intervention physiotherapists. Biomechanical component is assessed using the Pain Attitudes and Beliefs Score. The minimum value is 10 and the maximun value is 60. A higher score mean worse outcome
Measured: T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion)
Biopsychosocial component score of Pain Attitudes and Beliefs score - for intervention physiotherapists
Evolution of Biopsychosocial component score for intervention physiotherapists. Biopsychosocial component is assessed using the Pain Attitudes and Beliefs Score.The minimum value is 9 and the maximun value is 54. A higher score mean better outcome
Measured: T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion)
Biopsychosocial component score of Pain Attitudes and Beliefs score - for GPs
Evolution of Biopsychosocial component score for GPs. Biopsychosocial component is assessed using the Pain Attitudes and Beliefs Score.The minimum value is 9 and the maximun value is 54. A higher score mean better outcome
Measured: T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion)
Biomechanical component score of Pain Attitudes and Beliefs score - for GPs
Evolution of Biomechanical component score for GPs. Biomechanical component is assessed using the Pain Attitudes and Beliefs Score. The minimum value is 10 and the maximun value is 60. A higher score mean worse outcome
Measured: T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion)
Professional dialogues
Existence and types of dialogues between GP and other professionals
Measured: during the 12 months of follow up
Number of consultations or sessions
Number of consultations or sessions
Measured: during the 12 months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start21 Sep 2022
- Primary completion22 Jan 2026
- Study completion22 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, controlled, cluster trial. the project is multicentered.
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Aline RAMOND ROQUIN, MD-PHD, Principal investigator, Department of Family Medicine - University of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826757
- Sponsor's protocol ID
- 2020-A01039-30
- Acronym
- COLOMB
- Status last verified
- Jul 2026
- First submitted
- 3 Mar 2021
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
Publications
Ramond-Roquin A, Begue C, Vizzini J, Chhor S, Bouchez T, Parot-Schinkel E, Loiez A, Petit A, Ghali M, Peurois M, Bouton C. Effectiveness of coordinated care to reduce the risk of prolonged disability among patients suffering from subacute or recurrent acute low back pain in primary care: protocol of the CO.LOMB cluster-randomized, controlled study. Front Med (Lausanne). 2023 Jun 20;10:1156482. doi: 10.3389/fmed.2023.1156482. eCollection 2023.
PubMed 37409270
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Coordinated Care to Reduce the Risk of Prolonged Disability Among Patients Suffer From Subacute or Recurrent Acute Low Back Pain in Primary Care
- ClinicalTrials.gov ID
- NCT04826757
- Acronym / sponsor ID
- COLOMB / 2020-A01039-30
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 22 Jan 2026 (actual)
- Study completion
- 22 Feb 2027 (estimated)
- First posted
- 1 Apr 2021 (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.
Common low back pain affects about 23% of general population and can be associated with psychosocial difficulties and prolonged inability to work. Its management in France mainly depends on general practioners, and sometime on physiotherapists.
A coordinated care between general practioners, physiotherapists and occupational health services would help to improve the care pathway for patients and health professionals.
The main objective is to assess the impact of coordinated primary care and deployed at the territories' level, in subacute or acute recurrent low back pain patients in comparison with the standard care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised, controlled, cluster trial. the project is multicentered.
| Arm | Type | Receives |
|---|---|---|
| standard care | No intervention | –standard care for low back pain management by general practioners (GPs). the physiotherapist and occupational health services can be solicited independently by the patient or GP. |
| coordinated care | Experimental | Other: Coordinated careCoordinated care between general practioners, physiotherapist and occupational health services. An intervention training will be performed before the start of the study for any care professional's to elaborate coordination tools and have an active communication. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Patient consulting an investigator GP for subacute low back pain or acute recurrent low back pain
- Patient with occupational activity (including sick leave)
- Patient depending of occupational health service
- Obtaining the signature of the consent to participate in this trial
- Patient Registered with social security scheme
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Coordinated careCoordinated care between general practioners; physiotherapists and occupational health services. Early contact with occupational health service by the general practioner and use of occupational retention tool Active physiotherapy (Individual active, intensive and regular rehabilitation program with 15 sessions of 1 hour, at a rate of 2 or 3 sessions per week) | Other | coordinated care |
Primary outcome
Perceived inability at 1 year
Time frame: Enrollment to 12 months follow up
Ratio of patient presenting improvement equal or above 4 points of Roland Morris Disability Questionnaire. The minimum value of Roland Morris Disability Questionnaire is 0 and the maximun value is 24. A higher score mean worse outcome
25 secondary outcomes
Perceived inability
Time frame: Enrollment to 3 months follow up, Enrollment to 6 months follow up
Roland Morris Disability score over time
Time frame: Enrollment, 3 months, 6 months, 12 months
Pain perceived
Time frame: Enrollment - 3 months , Enrollment - 6 months and Enrollment -12 months
Numerical pain scale over time
Time frame: Enrollment, 3 months, 6 months, 12 months
Occupational status
Time frame: at 3 months, 6 months and 12 months
Employment rate
Time frame: Enrollment, 3 months, 6 months, 12 months
Sick leave
Time frame: during 12 months after inclusion
Improved patients
Time frame: at 3 months, 6 months and 12 months
Evolution of improved patients ratio
Time frame: Enrollment, 3 months, 6 months, 12 months
Mental component score of Short Form -12
Time frame: Enrollment, 3 months, 6 months, 12 months
Physical component score of Short Form -12
Time frame: Enrollment, 3 months, 6 months, 12 months
Occupational component score of Fear Avoidance Beliefs Questionnaire
Time frame: Enrollment, 3 months, 12 months
Physical activity component score of Fear Avoidance Beliefs Questionnaire
Time frame: Enrollment, 3 months, 12 months
Anxiety component score of Hospital Anxiety and Depression Scale
Time frame: Enrollment 3 months, 12 months
Depression component score of Hospital Anxiety and Depression Scale
Time frame: Enrollment, 3 months, 12 months
Coordination care score of Patient Centered Coordination by a Care Team questionnaire
Time frame: Enrollment, 3 months, 12 months
GP satisfaction related to patient care
Time frame: T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion)
Physiotherapist satisfaction related to patient care
Time frame: T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion)
Professionals trained for intervention
Time frame: Baseline intervention formations
Biomechanical component score of Pain Attitudes and Beliefs score - for intervention physiotherapists
Time frame: T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion)
Biopsychosocial component score of Pain Attitudes and Beliefs score - for intervention physiotherapists
Time frame: T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion)
Biopsychosocial component score of Pain Attitudes and Beliefs score - for GPs
Time frame: T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion)
Biomechanical component score of Pain Attitudes and Beliefs score - for GPs
Time frame: T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion)
Professional dialogues
Time frame: during the 12 months of follow up
Number of consultations or sessions
Time frame: during the 12 months of follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Derived from this study: PubMed 37409270Ramond-Roquin A, Begue C, Vizzini J, Chhor S, Bouchez T, Parot-Schinkel E, Loiez A, Petit A, Ghali M, Peurois M, Bouton C. Effectiveness of coordinated care to reduce the risk of prolonged disability among patients suffering from subacute or recurrent acute low back pain in primary care: protocol of the CO.LOMB cluster-randomized, controlled study. Front Med (Lausanne). 2023 Jun 20;10:1156482. doi: 10.3389/fmed.2023.1156482. eCollection 2023.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Aline RAMOND ROQUIN, MD-PHD principal investigator
Department of Family Medicine - University of Angers
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coordinated care in people with Low Back Pain, run by University Hospital, Angers at 20 sites in France.
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 19 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Perceived inability at 1 year (time frame: Enrollment to 12 months follow up). 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 NCT04826757, 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 13 Jul 2026.