Chronic Postsurgical PainNCT06126289
CSF Single-cell Sequencing and Proteomics of Chronic Postsurgical Pain in Patients With Lower Limb Fractures
An observational study of Chronic Postsurgical Pain, run by Xuzhou Central Hospital.
Trial summary
The purpose of this study is to assess the proteomics and transcriptomic differences between pain-free control subjects and patients with chronic postoperative pain through single-cell sequencing technology. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Postsurgical Pain
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 25 Dec 2023to 30 Jul 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who had undergone open reduction and internal fixation of the lower limbs and planned to take out the internal fixation were interviewed before surgery to collect the basic data ( gender, age, BMI, etc. ) and previous surgical information. Selecting the patients with the chronic postoperative pain，for one-to-one case matching.All patients and control subjects were without any analgesic medicatio during the 24hours before the investigation,and were not using any daily mediciation.Routine blood and urine assessments were within the normal range.
Who may be able to join
- ASA physical status 1 to 3 (males and females)
- Undergone open reduction and internal fixation of the lower limbs and plan to take out the internal fixation under spinal anesthesia
Who cannot join
- Absence of written consent
- Contraindication to regional anaesthesia
- Known dementia at time of operation
- History or opioid abuse
- Unexpected conversion of general anesthesia or surgery is not carried out
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cerebrospinal Fluid Single-cell Sequencing and Proteomics Analysis of the Chronic Postsurgical Pain in Patients Following Open Reduction Internal Fixation of Lower Limb Fractures
The purpose of this study is to assess the proteomics and transcriptomic differences between pain-free control subjects and patients with chronic postoperative pain through single-cell sequencing technology.
Read the detailed description
Chronic pain,one of the most frequent causes for patients to seek medical care,is a recognized health problem.Chronic postsurgical pain (CPSP), commonly defined as pain that develops after a surgical procedure and persists at least 3 months, constitutes a widely underdiagnosed and often poorly treated medical problem affecting 10-50% of all postsurgical patients. According to the reports,in the United States alone,1.9 million persons abused or were dependent on prescription opioid analgesics for chronic pain in 2013,contributing to one of the worst public health crises the developed world has recently faced.Here,open reduction and internal fixation of lower limb fractures ,what we focus, is a common surgical procedure in orthopedics and microscopic hand and foot surgery.The removal of the intramedullary nail can relieve anterior knee pain, but in a substantial number of patients, pain persists after nail removal.The most painful daily activities are kneeling and squatting.Therefore, it is increasingly important and urgent to solve the postoperative chronic pain of patients with lower extremity fractures surgery.
The underlying biology of chronic postoperative pain and genetic heritability is complex and not yet fully understood . A common feature of CPSP is that the painful sensations change from the familiar acute postoperative pain to a complex pain syndrome with nociplastic characteristics,neuropathic characteristics, or both. Preclinical studies have revealed that neuroinflammation is one of pathological hallmarks of CPSP. The transition from acute to chronic pain starts early within the first 2 weeks after nociception by peripheral and central inflammatory processes and activation of spinal glial cells.Repetitive nociception resulting from prolonged inflammatory and neuropathic responses to noxious stimuli causes a cascade of biochemical and structural changes to various pain pathways resulting in sensitization of the peripheral and CNS. Cytokines and neurotrophic factors have been identified as pivotal mediators involved in neuroimmune activation pathways and cascades in various preclinical chronic pain models.
The brain is surrounded by the meninges, a membranous covering that contains the cerebrospinal fluid (CSF).Its circulatory system transmits peripheral stimulation to the cerebrum, and central signal is transmitted to the dorsal root ganglion. CSF ,as a bridge between peripheral and central, contains a tightly regulated immune system and metabolitites and reflects the inflammatory processes and activation of spinal glial cells. However, knowledge is lacking about how CSF contains are altered with pain.We thus hypothesized that comparing the CSF protemics and immune transcriptomes associated with pain-free control subjects and patients with chronic postoperative pain would provide insights into the pathophysiology of CPSP. Here,a single-cell transcriptomic resource exploring the cerebrospinal fluid immune system and proteomics of patients with postoperative chronic pain will uncover the key molecules and pathways of CPSP.
- Conditions
- Chronic Postsurgical Pain
- Keywords
- Chronic Postsurgical pain, Single-cell sequencing, Cerebrospinal Fluid
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pain-free control subjects | According to the 11th Revision of International Classification of Diseases (ICD-11) of International Association for the Study of Pain(IASP) in 2019, diagnose whether patients have CPSP . Patients with no postoperative chronic pain after open reduction and internal fixation of lower limb fractures. | |
| Patients with chronic postsurgical pain | According to the 11th Revision of International Classification of Diseases (ICD-11) of International Association for the Study of Pain(IASP) in 2019, diagnose whether patients have CPSP . Patients with postsurgical chronic pain after open reduction and internal fixation of lower limb fractures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significantly different proteomics and transcriptomes between Chronic Postsurgical Pain and pain-free subjects
Differences in the proteins in the fluid around the lumbar, between Chronic Postsurgical Pain and Pain-free subjects.，will be quantified using Mass spectrometry，for:
neural cell adhesion molecule L1, complement C4-A, lysozyme C, receptor-type tyrosine-protein phosphatase zeta, apolipoprotein D, alpha-1-antichymotrypsin, granulins, calcium/calmodulin-dependent protein kinase type II subunit alpha, mast/stem cell growth factor receptor Kit, prolow-density lipoprotein receptor-related protein 1 and so on.
These proteins may identify the disease and define its mechanism.
Measured: Up to 3 months after fixation
Inflammatory cytokines in Chronic Postsurgical Pain patients
Biomarkers from CSF will be quantified using Meso Scale Discovery multiplex kit (K15210D), for:
CRP, Eotaxin, Eotaxin-3, FGF (basic), ICAM-1, IFN-γ, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12/IL-23p40, IL-13, IL-15, IL-16, IL-17A, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, PlGF, SAA, TARC, Tie-2, TNF-α, TNF-β, VCAM-1, VEGF-A, VEGF-C, VEGF-D, VEGFR-1/Flt-1.
The levels of these biomarkers will be compared between the group between CPSP and pain-free subjects.
Measured: Up to 3 months after fixation surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start25 Dec 2023 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Postsurgical 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126289
- Sponsor's protocol ID
- XZXY-LK-20230530-084
- Status last verified
- Jun 2023
- First submitted
- 31 Oct 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Scholz J, Finnerup NB, Attal N, Aziz Q, Baron R, Bennett MI, Benoliel R, Cohen M, Cruccu G, Davis KD, Evers S, First M, Giamberardino MA, Hansson P, Kaasa S, Korwisi B, Kosek E, Lavand'homme P, Nicholas M, Nurmikko T, Perrot S, Raja SN, Rice ASC, Rowbotham MC, Schug S, Simpson DM, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ, Barke A, Rief W, Treede RD; Classification Committee of the Neuropathic Pain Special Interest Group (NeuPSIG). The IASP classification of chronic pain for ICD-11: chronic neuropathic pain. Pain. 2019 Jan;160(1):53-59. doi: 10.1097/j.pain.0000000000001365.
PubMed 30586071van Ransbeeck A, Budilivski A, Spahn DR, Macrea L, Giuliani F, Maurer K. Pain Assessment Discrepancies: A Cross-Sectional Study Highlights the Amount of Underrated Pain. Pain Pract. 2018 Mar;18(3):360-367. doi: 10.1111/papr.12612. Epub 2017 Sep 20.
PubMed 28707777GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.
PubMed 30496104Clay FJ, Watson WL, Newstead SV, McClure RJ. A systematic review of early prognostic factors for persisting pain following acute orthopedic trauma. Pain Res Manag. 2012 Jan-Feb;17(1):35-44. doi: 10.1155/2012/935194.
PubMed 22518366Friesgaard KD, Gromov K, Knudsen LF, Brix M, Troelsen A, Nikolajsen L. Persistent pain is common 1 year after ankle and wrist fracture surgery: a register-based questionnaire study. Br J Anaesth. 2016 May;116(5):655-61. doi: 10.1093/bja/aew069.
PubMed 27106969Leliveld MS, Van Lieshout EMM, Polinder S, Verhofstad MHJ; TRAVEL Study Investigators. Effect of Transverse Versus Longitudinal Incisions on Anterior Knee Pain After Tibial Nailing (TRAVEL): A Multicenter Randomized Trial with 1-Year Follow-up. J Bone Joint Surg Am. 2022 Dec 21;104(24):2160-2169. doi: 10.2106/JBJS.22.00389. Epub 2022 Oct 25.
PubMed 36367768Rees S, Tutton E, Achten J, Bruce J, Costa ML. Patient experience of long-term recovery after open fracture of the lower limb: a qualitative study using interviews in a community setting. BMJ Open. 2019 Oct 9;9(10):e031261. doi: 10.1136/bmjopen-2019-031261.
PubMed 31601595Fitzcharles MA, Cohen SP, Clauw DJ, Littlejohn G, Usui C, Hauser W. Nociplastic pain: towards an understanding of prevalent pain conditions. Lancet. 2021 May 29;397(10289):2098-2110. doi: 10.1016/S0140-6736(21)00392-5.
PubMed 34062144Hankerd K, McDonough KE, Wang J, Tang SJ, Chung JM, La JH. Postinjury stimulation triggers a transition to nociplastic pain in mice. Pain. 2022 Mar 1;163(3):461-473. doi: 10.1097/j.pain.0000000000002366.
PubMed 34285154Wyss-Coray T, Mucke L. Inflammation in neurodegenerative disease--a double-edged sword. Neuron. 2002 Aug 1;35(3):419-32. doi: 10.1016/s0896-6273(02)00794-8.
PubMed 12165466
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrospinal Fluid Single-cell Sequencing and Proteomics Analysis of the Chronic Postsurgical Pain in Patients Following Open Reduction Internal Fixation of Lower Limb Fractures
- ClinicalTrials.gov ID
- NCT06126289
- Acronym / sponsor ID
- XZXY-LK-20230530-084
- Conditions
- Chronic Postsurgical Pain
- Keywords
- Chronic Postsurgical pain, Single-cell sequencing, Cerebrospinal Fluid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xuzhou Central HospitalUniversity, hospital or other
- Study start
- 25 Dec 2023 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 13 Nov 2023 (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.
The purpose of this study is to assess the proteomics and transcriptomic differences between pain-free control subjects and patients with chronic postoperative pain through single-cell sequencing technology.
Detailed description
Chronic pain,one of the most frequent causes for patients to seek medical care,is a recognized health problem.Chronic postsurgical pain (CPSP), commonly defined as pain that develops after a surgical procedure and persists at least 3 months, constitutes a widely underdiagnosed and often poorly treated medical problem affecting 10-50% of all postsurgical patients. According to the reports,in the United States alone,1.9 million persons abused or were dependent on prescription opioid analgesics for chronic pain in 2013,contributing to one of the worst public health crises the developed world has recently faced.Here,open reduction and internal fixation of lower limb fractures ,what we focus, is a common surgical procedure in orthopedics and microscopic hand and foot surgery.The removal of the intramedullary nail can relieve anterior knee pain, but in a substantial number of patients, pain persists after nail removal.The most painful daily activities are kneeling and squatting.Therefore, it is increasingly important and urgent to solve the postoperative chronic pain of patients with lower extremity fractures surgery.
The underlying biology of chronic postoperative pain and genetic heritability is complex and not yet fully understood . A common feature of CPSP is that the painful sensations change from the familiar acute postoperative pain to a complex pain syndrome with nociplastic characteristics,neuropathic characteristics, or both. Preclinical studies have revealed that neuroinflammation is one of pathological hallmarks of CPSP. The transition from acute to chronic pain starts early within the first 2 weeks after nociception by peripheral and central inflammatory processes and activation of spinal glial cells.Repetitive nociception resulting from prolonged inflammatory and neuropathic responses to noxious stimuli causes a cascade of biochemical and structural changes to various pain pathways resulting in sensitization of the peripheral and CNS. Cytokines and neurotrophic factors have been identified as pivotal mediators involved in neuroimmune activation pathways and cascades in various preclinical chronic pain models.
The brain is surrounded by the meninges, a membranous covering that contains the cerebrospinal fluid (CSF).Its circulatory system transmits peripheral stimulation to the cerebrum, and central signal is transmitted to the dorsal root ganglion. CSF ,as a bridge between peripheral and central, contains a tightly regulated immune system and metabolitites and reflects the inflammatory processes and activation of spinal glial cells. However, knowledge is lacking about how CSF contains are altered with pain.We thus hypothesized that comparing the CSF protemics and immune transcriptomes associated with pain-free control subjects and patients with chronic postoperative pain would provide insights into the pathophysiology of CPSP. Here,a single-cell transcriptomic resource exploring the cerebrospinal fluid immune system and proteomics of patients with postoperative chronic pain will uncover the key molecules and pathways of CPSP.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain-free control subjects | – | –According to the 11th Revision of International Classification of Diseases (ICD-11) of International Association for the Study of Pain(IASP) in 2019, diagnose whether patients have CPSP . Patients with no postoperative chronic pain after open reduction and internal fixation of lower limb fractures. |
| Patients with chronic postsurgical pain | – | –According to the 11th Revision of International Classification of Diseases (ICD-11) of International Association for the Study of Pain(IASP) in 2019, diagnose whether patients have CPSP . Patients with postsurgical chronic pain after open reduction and internal fixation of lower limb fractures. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who had undergone open reduction and internal fixation of the lower limbs and planned to take out the internal fixation were interviewed before surgery to collect the basic data ( gender, age, BMI, etc. ) and previous surgical information. Selecting the patients with the chronic postoperative pain，for one-to-one case matching.All patients and control subjects were without any analgesic medicatio during the 24hours before the investigation,and were not using any daily mediciation.Routine blood and urine assessments were within the normal range.
Key inclusion criteria (2 listed)
- ASA physical status 1 to 3 (males and females)
- Undergone open reduction and internal fixation of the lower limbs and plan to take out the internal fixation under spinal anesthesia
Key exclusion criteria (5 listed)
- Absence of written consent
- Contraindication to regional anaesthesia
- Known dementia at time of operation
- History or opioid abuse
- Unexpected conversion of general anesthesia or surgery is not carried out
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Significantly different proteomics and transcriptomes between Chronic Postsurgical Pain and pain-free subjects
Time frame: Up to 3 months after fixation
Differences in the proteins in the fluid around the lumbar, between Chronic Postsurgical Pain and Pain-free subjects.，will be quantified using Mass spectrometry，for: neural cell adhesion molecule L1, complement C4-A, lysozyme C, receptor-type tyrosine-protein phosphatase zeta, apolipoprotein D, alpha-1-antichymotrypsin, granulins, calcium/calmodulin-dependent protein kinase type II subunit alpha, mast/stem cell growth factor receptor Kit, prolow-density lipoprotein receptor-related protein 1 and so on. These proteins may identify the disease and define its mechanism.
Inflammatory cytokines in Chronic Postsurgical Pain patients
Time frame: Up to 3 months after fixation surgery
Biomarkers from CSF will be quantified using Meso Scale Discovery multiplex kit (K15210D), for: CRP, Eotaxin, Eotaxin-3, FGF (basic), ICAM-1, IFN-γ, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12/IL-23p40, IL-13, IL-15, IL-16, IL-17A, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, PlGF, SAA, TARC, Tie-2, TNF-α, TNF-β, VCAM-1, VEGF-A, VEGF-C, VEGF-D, VEGFR-1/Flt-1. The levels of these biomarkers will be compared between the group between CPSP and pain-free subjects.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Background: PubMed 30586071Scholz J, Finnerup NB, Attal N, Aziz Q, Baron R, Bennett MI, Benoliel R, Cohen M, Cruccu G, Davis KD, Evers S, First M, Giamberardino MA, Hansson P, Kaasa S, Korwisi B, Kosek E, Lavand'homme P, Nicholas M, Nurmikko T, Perrot S, Raja SN, Rice ASC, Rowbotham MC, Schug S, Simpson DM, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ, Barke A, Rief W, Treede RD; Classification Committee of the Neuropathic Pain Special Interest Group (NeuPSIG). The IASP classification of chronic pain for ICD-11: chronic neuropathic pain. Pain. 2019 Jan;160(1):53-59. doi: 10.1097/j.pain.0000000000001365.
- Background: PubMed 28707777van Ransbeeck A, Budilivski A, Spahn DR, Macrea L, Giuliani F, Maurer K. Pain Assessment Discrepancies: A Cross-Sectional Study Highlights the Amount of Underrated Pain. Pain Pract. 2018 Mar;18(3):360-367. doi: 10.1111/papr.12612. Epub 2017 Sep 20.
- Background: PubMed 30496104GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.
- Background: PubMed 22518366Clay FJ, Watson WL, Newstead SV, McClure RJ. A systematic review of early prognostic factors for persisting pain following acute orthopedic trauma. Pain Res Manag. 2012 Jan-Feb;17(1):35-44. doi: 10.1155/2012/935194.
- Background: PubMed 27106969Friesgaard KD, Gromov K, Knudsen LF, Brix M, Troelsen A, Nikolajsen L. Persistent pain is common 1 year after ankle and wrist fracture surgery: a register-based questionnaire study. Br J Anaesth. 2016 May;116(5):655-61. doi: 10.1093/bja/aew069.
- Background: PubMed 36367768Leliveld MS, Van Lieshout EMM, Polinder S, Verhofstad MHJ; TRAVEL Study Investigators. Effect of Transverse Versus Longitudinal Incisions on Anterior Knee Pain After Tibial Nailing (TRAVEL): A Multicenter Randomized Trial with 1-Year Follow-up. J Bone Joint Surg Am. 2022 Dec 21;104(24):2160-2169. doi: 10.2106/JBJS.22.00389. Epub 2022 Oct 25.
- Background: PubMed 31601595Rees S, Tutton E, Achten J, Bruce J, Costa ML. Patient experience of long-term recovery after open fracture of the lower limb: a qualitative study using interviews in a community setting. BMJ Open. 2019 Oct 9;9(10):e031261. doi: 10.1136/bmjopen-2019-031261.
- Background: PubMed 34062144Fitzcharles MA, Cohen SP, Clauw DJ, Littlejohn G, Usui C, Hauser W. Nociplastic pain: towards an understanding of prevalent pain conditions. Lancet. 2021 May 29;397(10289):2098-2110. doi: 10.1016/S0140-6736(21)00392-5.
- Background: PubMed 34285154Hankerd K, McDonough KE, Wang J, Tang SJ, Chung JM, La JH. Postinjury stimulation triggers a transition to nociplastic pain in mice. Pain. 2022 Mar 1;163(3):461-473. doi: 10.1097/j.pain.0000000000002366.
- Results publication: PubMed 12165466Wyss-Coray T, Mucke L. Inflammation in neurodegenerative disease--a double-edged sword. Neuron. 2002 Aug 1;35(3):419-32. doi: 10.1016/s0896-6273(02)00794-8.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Postsurgical Pain, run by Xuzhou Central Hospital.
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 2 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Zi D Zhu, Doctor (+86 18168779150, zhuyz@188.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significantly different proteomics and transcriptomes between Chronic Postsurgical Pain and pain-free subjects (time frame: Up to 3 months after fixation). The study lists 2 primary outcomes in all. 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 NCT06126289, which also lists 10 linked publications.
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 Nov 2023.