Carpal Tunnel SyndromeNCT04579783
Corticosteroid and Repeated Dextrose Hydro-dissection for Carpal Tunnel Syndrome Patients
A study testing Triamcinolone Acetonide and Dextrose 5% in water in people with Carpal Tunnel Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Carpal tunnel syndrome (CTS) is the most prevalent peripheral nerve entrapment of upper limb. Typical symptoms comprise pain, numbness or tingling of the thumb and index, middle or ring fingers. Thumb weakness and decreased grip strength can occur in the later stage. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Triamcinolone Acetonide and Dextrose 5% in water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Nov 2020to Dec 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presenting with carpal tunnel syndrome symptoms, including nocturnal, postural, or motion-associated paresthesias +/- pain of the median nerve distribution area in the subjective hand
- Confirmed Electrophysiological confirmed median neuropathy at the wrist with mild to moderate degree
- Persistent symptoms for more than 3 months
Who cannot join
- Patients with suspicious of CTS mimic condition, including cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome
- Recent corticosteroid injection to the carpal tunnel within 6 months
- Thenar muscle atrophy
- Previous history of carpal tunnel surgical release
- History of wrist trauma
- Regular use of systemic nonsteroidal anti-inflammatory drugs, corticosteroids or diuretics
- Pregnancy
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital, Bei-Hu Branch
Taipei, Wanhua District, 108
Ke-Vin Chang, MD, PhD, kvchang011@gmail.com
About this study
Official title: Comparison of Corticosteroid and Repeated Dextrose Hydro-dissection for Carpal Tunnel Syndrome Patients
Carpal tunnel syndrome (CTS) is the most prevalent peripheral nerve entrapment of upper limb. Typical symptoms comprise pain, numbness or tingling of the thumb and index, middle or ring fingers. Thumb weakness and decreased grip strength can occur in the later stage. Currently treatments included physical modalities (low power laser, transcutaneous electrical nerve stimulation, ultrasound), medication, splinting, injection and surgery. Ultrasound guided intracarpal hydro-dissection of median nerve had been proposed based on its accurate localization, while the injectates were diverse. Corticosteroid has been widely used for CTS for decades. However, growing evidences suggested that 5% dextrose, normal saline, platelet rich plasma injection also have therapeutic effects on alleviating CTS symptoms. Among the injectates, a single 5% dextrose injection could be considered as a substitute of corticosteroid based on its long term effect up to six months. However, the clinical efficacy of 5% dextrose injection has not validated by the further study. The investigators aim to compare the therapeutic effect of 5% dextrose injection with corticosteroid injection in patients with CTS, up to 12 weeks follow up.
Read the detailed description
Introduction:
Carpal tunnel syndrome (CTS) is the most prevalent peripheral nerve entrapment of upper limb. Typical symptoms comprise pain, numbness or tingling of the thumb and index, middle or ring fingers. Thumb weakness and decreased grip strength can occur in the later stage. Currently treatments included physical modalities (low power laser, transcutaneous electrical nerve stimulation, ultrasound), medication, splinting, injection and surgery. Ultrasound guided intracarpal hydro-dissection of median nerve had been proposed based on its accurate localization, while the injectates were diverse. Corticosteroid has been widely used for CTS for decades. However, growing evidences suggested that 5% dextrose, normal saline, platelet rich plasma injection also have therapeutic effects on alleviating CTS symptoms. Among the injectates, a single 5% dextrose injection could be considered as a substitute of corticosteroid based on its long term effect up to six months. However, the clinical efficacy of 5% dextrose injection has not validated by the further study. Whether repeated injection could expand the treatment effect was undetermined. The investigators aim to compare the therapeutic effect repeated 5% dextrose injection with corticosteroid injection in patients with CTS, up to 12 weeks follow up.
Material and methods:
Participants: 60 adult patients (>20 year olds) with carpal tunnel syndrome, recruited from outpatient clinic.
Inclusion criteria: Presenting with CTS symptoms, including nocturnal, postural, or motion-associated paresthesias +/- pain of the median nerve distribution area in the subjective hand. Confirmed Electrophysiological confirmed median neuropathy at the wrist with mild to moderate degree. Persistent symptoms for more than 3 months
Exclusion Criteria: Patients cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome. Recent corticosteroid injection to the carpal tunnel within 6 months.
Thenar muscle atrophy. Previous history of carpal tunnel surgical release. History of wrist trauma. Regular use of systemic nonsteroidal anti-inflammatory drugs, corticosteroids or diuretics. Pregnancy. Cognitive impairment.
Objective:
The aim of this study is to compare the treatment effect of repeated 5 mL 5% dextrose with 5mL triamcinolone acetonide injection in patients with CTS.
Detail of the intervention The study is designated as randomized, double blinded, and parallel experiment. The randomization was decided by random table in block of 4.
Repeated ultrasound guided injection intracarpal median nerve hydro-dissection with 5 mL 5% dextrose (Group B) or 5mL triamcinolone acetonide injection (Group A) in patients with CTS.
The regimen was shown as below:
Group A: 1st injection (0 week): 40mg triamcinolone acetonide (40mg/mL) with 4mL normal saline, 2nd injection (6 week): 5 mL normal saline Group B: 1st injection (0 week): 5 mL 5% dextrose, 2nd injection (6 week): 5 mL 5% dextrose
Skin infiltration with local anesthetic (lidocaine cream) at the needle insertion site was performed before the injection. Then injection was performed after sterilization. The equipment for ultrasound-guided injection will be high-resolution ultrasound machine with the linear probe.
Outcome measurement:
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and Visual analogue scale (VAS) before 1st injection, before 2nd injection (6-week) and 12-week after first injection.
Electrophysiological evaluation (amplitude and distal latency of median nerve compound motor action potential and sensory nerve action potential); cross-sectional area of median nerve at carpal tunnel inlet, were evaluated before and 12-week after 1st injection.
Global assessment of treatment was evaluated at before 2nd injection (6-week) and 12-week after first injection.
Statistical analysis:
Continuous variables Student's t test: fit assumption of normal distribution Mann-Whitney test: does not fit the assumption of normal distribution Categorical variables (1) Chi-square test (2) Fisher exact test: sparse data (3)Repeated-measures analysis of variance (ANOVA) was used to evaluate the effect of injection with post-hoc Bonferroni test to evaluate intra-group data at different time-frame
Keywords: Hydro-dissection, corticosteroid, dextrose, carpal tunnel syndrome
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Triamcinolone Acetonide, Dextrose 5% in water
- Keywords
- Hydro-dissection, Dextrose, Corticosteroid
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone AcetonideDrug
Also called Shincort
Group A: 40mg triamcinolone acetonide (1mL) + 4mL normal saline
Dextrose 5% in waterDrug
Also called Vitagen
Group B: 5mL 5% dextrose
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound intracarpal corticosteroid injection | Active comparator | Twice ultrasound-guided hydro-dissection of median nerve at carpal tunnel level.
1st injection (0 week): 40mg triamcinolone acetonide (40mg/mL ) with 4mL normal saline, 2nd injection (6 week): 5 mL normal saline Receives: Drug: Triamcinolone Acetonide |
| Ultrasound guided intracarpal dextrose hydro-dissection | Active comparator | Twice ultrasound-guided hydro-dissection of median nerve at carpal tunnel level.
Group B: 1st injection (0 week): 5 mL 5% dextrose, 2nd injection (6 week): 5 mL 5% dextrose Receives: Drug: Dextrose 5% in water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Carpal Tunnel Syndrome Questionnaire
Evaluation of symptom severity (11-question) and functional impairment (8-question) subscale. The scores range from 0 to 5 points for each question, with higher scores indicating greater severity and dysfunction.
Measured: Change of the score between 6 weeks and baseline(1st injection), and change of the score between 12 weeks and baseline (1st injection))
Secondary outcomes (8)
Visual analogue scale
Pain intensity evaluation, from 0 to 10 points, a 11-point scale. The higher scores indicate severe pain.
Measured: Change of the score between 6 weeks and baseline(1st injection), and change of the score between 12 weeks and baseline (1st injection))
Distal latency of median nerve sensory nerve action potential (Unit: ms)
recoding at index finger by antidromic stimulation
Measured: change of the score between 12 weeks and baseline (1st injection)
Amplitude of median nerve sensory nerve action potential (Unit: μV)
recording at index finger by antidromic stimulation
Measured: change of the score between 12 weeks and baseline (1st injection)
Distal latency of median nerve compound motor action potential (Unit: ms)
recording at abductor pollicis brevis muscle
Measured: change of the score between 12 weeks and baseline (1st injection)
Amplitude of median nerve compound motor action potential (Unit: mV)
recording at abductor pollicis brevis muscle
Measured: change of the score between 12 weeks and baseline (1st injection)
Cross-sectional area of median nerve (unit: mm2)
Ultrasound evaluation of the median nerve size
Measured: Change of the score between 6 weeks and baseline(1st injection), and change of the score between 12 weeks and baseline (1st injection))
Global assessment of treatment (1st)
self-reported global assessment of treatment on 5 category (much improved, improved, no change, worse, or much worse)
Measured: 6-week after 1st injection (before 2nd injection)
Global assessment of treatment (2nd)
self-reported global assessment of treatment on 5 category (much improved, improved, no change, worse, or much worse)
Measured: 6-week after 2nd injection (12-week after 1st injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start27 Nov 2020
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (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 Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ke-Vin Chang, MD,PhD, Principal investigator, National Taiwan University Hospital Beihu Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579783
- Sponsor's protocol ID
- 202007021MINB
- Status last verified
- Dec 2021
- First submitted
- 27 Sep 2020
- Last updated
- 15 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Tsai CK, Chen LC. Six-month Efficacy of Perineural Dextrose for Carpal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Controlled Trial. Mayo Clin Proc. 2017 Aug;92(8):1179-1189. doi: 10.1016/j.mayocp.2017.05.025.
PubMed 28778254
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Corticosteroid and Repeated Dextrose Hydro-dissection for Carpal Tunnel Syndrome Patients
- ClinicalTrials.gov ID
- NCT04579783
- Acronym / sponsor ID
- 202007021MINB
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Hydro-dissection, Dextrose, Corticosteroid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 8 Oct 2020 (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.
Carpal tunnel syndrome (CTS) is the most prevalent peripheral nerve entrapment of upper limb. Typical symptoms comprise pain, numbness or tingling of the thumb and index, middle or ring fingers. Thumb weakness and decreased grip strength can occur in the later stage. Currently treatments included physical modalities (low power laser, transcutaneous electrical nerve stimulation, ultrasound), medication, splinting, injection and surgery. Ultrasound guided intracarpal hydro-dissection of median nerve had been proposed based on its accurate localization, while the injectates were diverse. Corticosteroid has been widely used for CTS for decades. However, growing evidences suggested that 5% dextrose, normal saline, platelet rich plasma injection also have therapeutic effects on alleviating CTS symptoms. Among the injectates, a single 5% dextrose injection could be considered as a substitute of corticosteroid based on its long term effect up to six months. However, the clinical efficacy of 5% dextrose injection has not validated by the further study. The investigators aim to compare the therapeutic effect of 5% dextrose injection with corticosteroid injection in patients with CTS, up to 12 weeks follow up.
Detailed description
Introduction:
Carpal tunnel syndrome (CTS) is the most prevalent peripheral nerve entrapment of upper limb. Typical symptoms comprise pain, numbness or tingling of the thumb and index, middle or ring fingers. Thumb weakness and decreased grip strength can occur in the later stage. Currently treatments included physical modalities (low power laser, transcutaneous electrical nerve stimulation, ultrasound), medication, splinting, injection and surgery. Ultrasound guided intracarpal hydro-dissection of median nerve had been proposed based on its accurate localization, while the injectates were diverse. Corticosteroid has been widely used for CTS for decades. However, growing evidences suggested that 5% dextrose, normal saline, platelet rich plasma injection also have therapeutic effects on alleviating CTS symptoms. Among the injectates, a single 5% dextrose injection could be considered as a substitute of corticosteroid based on its long term effect up to six months. However, the clinical efficacy of 5% dextrose injection has not validated by the further study. Whether repeated injection could expand the treatment effect was undetermined. The investigators aim to compare the therapeutic effect repeated 5% dextrose injection with corticosteroid injection in patients with CTS, up to 12 weeks follow up.
Material and methods:
Participants: 60 adult patients (>20 year olds) with carpal tunnel syndrome, recruited from outpatient clinic.
Inclusion criteria: Presenting with CTS symptoms, including nocturnal, postural, or motion-associated paresthesias +/- pain of the median nerve distribution area in the subjective hand. Confirmed Electrophysiological confirmed median neuropathy at the wrist with mild to moderate degree. Persistent symptoms for more than 3 months
Exclusion Criteria: Patients cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome. Recent corticosteroid injection to the carpal tunnel within 6 months.
Thenar muscle atrophy. Previous history of carpal tunnel surgical release. History of wrist trauma. Regular use of systemic nonsteroidal anti-inflammatory drugs, corticosteroids or diuretics. Pregnancy. Cognitive impairment.
Objective:
The aim of this study is to compare the treatment effect of repeated 5 mL 5% dextrose with 5mL triamcinolone acetonide injection in patients with CTS.
Detail of the intervention The study is designated as randomized, double blinded, and parallel experiment. The randomization was decided by random table in block of 4.
Repeated ultrasound guided injection intracarpal median nerve hydro-dissection with 5 mL 5% dextrose (Group B) or 5mL triamcinolone acetonide injection (Group A) in patients with CTS.
The regimen was shown as below:
Group A: 1st injection (0 week): 40mg triamcinolone acetonide (40mg/mL) with 4mL normal saline, 2nd injection (6 week): 5 mL normal saline Group B: 1st injection (0 week): 5 mL 5% dextrose, 2nd injection (6 week): 5 mL 5% dextrose
Skin infiltration with local anesthetic (lidocaine cream) at the needle insertion site was performed before the injection. Then injection was performed after sterilization. The equipment for ultrasound-guided injection will be high-resolution ultrasound machine with the linear probe.
Outcome measurement:
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and Visual analogue scale (VAS) before 1st injection, before 2nd injection (6-week) and 12-week after first injection.
Electrophysiological evaluation (amplitude and distal latency of median nerve compound motor action potential and sensory nerve action potential); cross-sectional area of median nerve at carpal tunnel inlet, were evaluated before and 12-week after 1st injection.
Global assessment of treatment was evaluated at before 2nd injection (6-week) and 12-week after first injection.
Statistical analysis:
Continuous variables Student's t test: fit assumption of normal distribution Mann-Whitney test: does not fit the assumption of normal distribution Categorical variables (1) Chi-square test (2) Fisher exact test: sparse data (3)Repeated-measures analysis of variance (ANOVA) was used to evaluate the effect of injection with post-hoc Bonferroni test to evaluate intra-group data at different time-frame
Keywords: Hydro-dissection, corticosteroid, dextrose, carpal tunnel syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound intracarpal corticosteroid injection | Active comparator | Drug: Triamcinolone AcetonideTwice ultrasound-guided hydro-dissection of median nerve at carpal tunnel level. 1st injection (0 week): 40mg triamcinolone acetonide (40mg/mL ) with 4mL normal saline, 2nd injection (6 week): 5 mL normal saline |
| Ultrasound guided intracarpal dextrose hydro-dissection | Active comparator | Drug: Dextrose 5% in waterTwice ultrasound-guided hydro-dissection of median nerve at carpal tunnel level. Group B: 1st injection (0 week): 5 mL 5% dextrose, 2nd injection (6 week): 5 mL 5% dextrose |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presenting with carpal tunnel syndrome symptoms, including nocturnal, postural, or motion-associated paresthesias +/- pain of the median nerve distribution area in the subjective hand
- Confirmed Electrophysiological confirmed median neuropathy at the wrist with mild to moderate degree
- Persistent symptoms for more than 3 months
Key exclusion criteria (8 listed)
- Patients with suspicious of CTS mimic condition, including cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome
- Recent corticosteroid injection to the carpal tunnel within 6 months
- Thenar muscle atrophy
- Previous history of carpal tunnel surgical release
- History of wrist trauma
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 |
|---|---|---|
| Triamcinolone AcetonideAlso: ShincortGroup A: 40mg triamcinolone acetonide (1mL) + 4mL normal saline | Drug | Ultrasound intracarpal corticosteroid injection |
| Dextrose 5% in waterAlso: VitagenGroup B: 5mL 5% dextrose | Drug | Ultrasound guided intracarpal dextrose hydro-dissection |
Primary outcome
Boston Carpal Tunnel Syndrome Questionnaire
Time frame: Change of the score between 6 weeks and baseline(1st injection), and change of the score between 12 weeks and baseline (1st injection))
Evaluation of symptom severity (11-question) and functional impairment (8-question) subscale. The scores range from 0 to 5 points for each question, with higher scores indicating greater severity and dysfunction.
8 secondary outcomes
Visual analogue scale
Time frame: Change of the score between 6 weeks and baseline(1st injection), and change of the score between 12 weeks and baseline (1st injection))
Distal latency of median nerve sensory nerve action potential (Unit: ms)
Time frame: change of the score between 12 weeks and baseline (1st injection)
Amplitude of median nerve sensory nerve action potential (Unit: μV)
Time frame: change of the score between 12 weeks and baseline (1st injection)
Distal latency of median nerve compound motor action potential (Unit: ms)
Time frame: change of the score between 12 weeks and baseline (1st injection)
Amplitude of median nerve compound motor action potential (Unit: mV)
Time frame: change of the score between 12 weeks and baseline (1st injection)
Cross-sectional area of median nerve (unit: mm2)
Time frame: Change of the score between 6 weeks and baseline(1st injection), and change of the score between 12 weeks and baseline (1st injection))
Global assessment of treatment (1st)
Time frame: 6-week after 1st injection (before 2nd injection)
Global assessment of treatment (2nd)
Time frame: 6-week after 2nd injection (12-week after 1st injection)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Background: PubMed 28778254Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Tsai CK, Chen LC. Six-month Efficacy of Perineural Dextrose for Carpal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Controlled Trial. Mayo Clin Proc. 2017 Aug;92(8):1179-1189. doi: 10.1016/j.mayocp.2017.05.025.
- Individual participant dataSharing planned: No
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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.
Ke-Vin Chang, MD,PhD principal investigator
National Taiwan University Hospital Beihu Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone Acetonide and Dextrose 5% in water in people with Carpal Tunnel Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 8 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 15 Dec 2021. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ke-Vin Chang, MD, PhD (+886-2-23712121 ext. 5309, kvchang011@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Carpal Tunnel Syndrome Questionnaire (time frame: Change of the score between 6 weeks and baseline(1st injection), and change of the score between 12 weeks and baseline (1st injection))). 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 NCT04579783, 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 15 Dec 2021.