Malignant Neoplasms of Digestive OrgansPhase 4NCT03210376
Neuromuscular Blockade on Shoulder Pain of Elderly
A Phase 4 study testing Deep Neuromuscular Blockade (NMB), Moderate Neuromuscular Blockade (NMB) and Sugammadex in people with Malignant Neoplasms of Digestive Organs and Malignant Neoplasms of Female Genital Organs, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Insufflation pressure (IP) is the creation of a pressure barrier of air/gas within the abdomen to allow the surgeon more space to work during abdominal surgery. Shoulder pain is a common complaint from patients who have had abdominal surgery and the pain is thought to be related to the use of IP. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Malignant Neoplasms of Digestive Organs, Malignant Neoplasms of Female Genital Organs, Malignant Neoplasms of Male Genital Organs
- What is being tested?
- Deep Neuromuscular Blockade (NMB), Moderate Neuromuscular Blockade (NMB) and Sugammadex
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2017to 22 Oct 2020
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients 65 years of age or older
- Patients having robotic prostatectomy
- Written informed consent
Who cannot join
- Patient with known hypersensitivity to Rocuronium, Sugammadex or its components
- Patients with severe renal insufficiency, defined and confirmed by an estimated creatinine clearance equal or lower than 30 mL/min, per institutional laboratory.
- Patients with history of severe liver disease, defined as and confirmed by elevated ALT and AST greater than 1.5 times the Upper Limit of Normal along with Albumin less than 3 OR INR 1.5 or greater per institutional laboratory.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: The Effect of Deep Neuromuscular Blockade With Sugammadex Reversal on Shoulder Pain of Elderly Patients Undergoing Robotic Surgery: A Single-Center Double-Blinded Randomized Controlled Trial
Insufflation pressure (IP) is the creation of a pressure barrier of air/gas within the abdomen to allow the surgeon more space to work during abdominal surgery. Shoulder pain is a common complaint from patients who have had abdominal surgery and the pain is thought to be related to the use of IP.
In addition to anesthesia (which keeps you asleep during surgery), the current standard practice is to block the nerve-muscle junction with a type of drug called neuromuscular blockade (NMB) which paralyzes the abdominal muscles. This means that a lower level of insufflation pressure is needed by the surgeon.
Read more
To reverse the effects of NMB after surgery, a drug called neostigmine is given.
The goal of this clinical research study is to compare the use of standard-of-care moderate NMB and neostigmine to the use of deep NMB and a drug called Sugammadex when given to elderly patients (patients who are 65 years of age or older) who are scheduled to have robotic abdominal surgery. "Deep" and "moderate" in this study refers to the dose or strength of the NMB given.
This is an investigational study. Sugammadex and neostigmine are FDA approved and commercially available for the reversal of NMB. It is considered investigational to compare Sugammadex and neostigmine to learn if the use of one or the other in elderly patients can reduce the level of shoulder pain after surgery.
Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.
Read the detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups before your surgery. This is done because no one knows if one group is better, the same, or worse than the other.
- In Group 1, you will receive deep NMB and Sugammadex.
- In Group 2, you will receive moderate NMB and neostigmine.
Neither you nor the surgeon or surgical staff will know to which group you have been assigned. The surgeon will not know which group you are in because researchers want to learn how much, if at all, the surgeon needs to adjust the insufflation pressure during surgery. However, if needed for your safety, the surgeon will be able to find out which group you are in.
For your safety, the anesthesiologist will know to which group you have been assigned.
Surgery and Study Drug Administration:
After you have been assigned to a study group, you will have your surgery as scheduled. You will sign a separate consent form for surgery which describes the procedure and its risks in more detail. You will also sign a separate consent form to receive anesthesia.
Before your surgery, blood (about 2 teaspoons) will be drawn for biomarker testing. Biomarkers are found in the blood/tissue and may be related to the status of the disease and/or your reaction to the study drug(s).
During the surgery, the insufflation pressure that is being used, including any changes that are made to the pressure, will be recorded. After the surgery has been completed, you will receive either Sugammadex or neostigmine by vein until the effects of the NMB have been reversed.
You will recover after surgery in the post-anesthesia care unit (PACU). At about 15, 45, and 90 minutes after your surgery, a PACU nurse will ask you about any shoulder pain you are feeling and if so, how intense the pain is. Information about how long you stay in the hospital after surgery and if you have any side effects after surgery (such as nausea/vomiting or shoulder pain) will also be collected from your medical record.
Follow-Up:
After 30 days after you leave the hospital, you will be called by a member of the study staff to ask how you are doing and if you have had any additional hospitalizations since leaving the hospital. This phone call should last about 5-10 minutes.
Length of Study Participation:
Your participation in this study will be over after completing the 30-day follow up phone call.
- Conditions
- Malignant Neoplasms of Digestive Organs, Malignant Neoplasms of Female Genital Organs, Malignant Neoplasms of Male Genital Organs, Malignant Neoplasms of Urinary Tract
- Being tested
- Deep Neuromuscular Blockade (NMB), Moderate Neuromuscular Blockade (NMB), Sugammadex, Neostigmine, Pain Assessment
- Keywords
- Malignant neoplasms of digestive organs, Malignant neoplasms of female genital organs, Malignant neoplasms of male genital organs, Malignant neoplasms of urinary tract, Neuromuscular blockade, NMB, Sugammadex, Neostigmine, Pain Assessment, Survey
- Medical subject headings
- Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Neuromuscular Blockade (NMB)Drug
Deep Neuromuscular Blockade (NMB) given during surgery.
Moderate Neuromuscular Blockade (NMB)Drug
Moderate Neuromuscular Blockade (NMB) given during surgery.
SugammadexDrug
4 mg/Kg, intravenously as a single bolus injection after surgery.
NeostigmineDrug
70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute after surgery.
Pain AssessmentBehavioural
Also called Survey
Pain assessment done at about 15, 45, and 90 minutes after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Deep Neuromuscular Blockade (NMB) + Sugammadex | Experimental | Deep Neuromuscular Blockade (NMB) given during surgery.
Sugammadex intravenously as a single bolus injection after surgery.
Pain assessment done at about 15, 45, and 90 minutes after surgery. Receives: Drug: Deep Neuromuscular Blockade (NMB); Drug: Sugammadex; Behavioral: Pain Assessment |
| Moderate Neuromuscular Blockade (NMB) + Neostigmine | Experimental | Moderate Neuromuscular Blockade (NMB) given during surgery.
Neostigmine intravenously slowly over a period of at least 1 minute after surgery.
Pain assessment done at about 15, 45, and 90 minutes after surgery. Receives: Drug: Moderate Neuromuscular Blockade (NMB); Drug: Neostigmine; Behavioral: Pain Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Who Reported Shoulder Pain
Visual Analog Scale (VAS) pain score (0-10) for shoulder pain recorded, where 0 means no pain and 10 means the worst pain ever experienced . Percentage of participants who experienced should pain.
Measured: 30 days
Secondary outcomes (6)
Cumulative Intraoperative Insufflation Pressure
Intra-abdominal insufflation time and pressure directed by the surgeon and recorded continuously by the clinical coordinator until the time of desufflation.
Measured: Day 0 - IntraOperative-From beginning of pneumoperitoneum to desufflation (an average of 166 minutes)
Percentage of Muscle Response Using Train-of-Four (TOF) in Post-Anesthesia Care Unit (PACU) to Measure Residual Muscle Relaxation
The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the DNMB group, the rate will be adjusted and boluses given to maintain 1-2 post tetanic responses during the pneumoperitoneum. NMB will be reversed with Sugammadex 4 mg/Kg, intravenously as a single bolus injection, at the end of the surgery. Percentage of measured contraction strength of the fourth stimulus compared to the first stimulus.
Measured: Day 0 - Arrival time at PACU, an average of 3 minutes
Readiness to Discharge From the Post-Anesthesia Care Unit (PACU)
Determined by the Dansk Selskab for Anæstesiologi og Intensiv Medicin(DASAIM)discharge criteria.Pts considered ready to discharge when the sum of all categories is<4 and no single category has a score of >1.Sedation.0:Patient is fully awake.1: Patient is asleep,aroused by verbal stimulation.2:Patient is asleep, aroused by physical stimulation.3:Patient is asleep,cannot be aroused.Respiratory Rate.0:Respiratory rate>10. 1: Snoring,10< RR<30. 2:R<10 or RR>30/min.3:Periods of apnea or obstructive patterns.Oxygen Saturation.0:SpO2 ≥ 94%.1:90%≤SpO2<94%. 2:85%≤ SpO2 < 90%.3:SpO2 < 85%. Systolic Blood Pressure. 0:SBP ≥ 100mmHg.1:90mmHg≤SBP< 100mmHg.2:80mmHg≤SBP< 90mmHg or SBP>220mmHg.3:SBP<80mmHg.Heart Rate.0:50<HR≤100.1:100<HR≤120.2:40<HR≤ 50 or 120<HR≤130.3:HR<40 or HR>130.Pain at rest.0:No pain 1:Light pain.2:Moderate pain.3:Severe pain.Nausea.0:No nausea or vomiting.1:Light nausea or vomiting without previous nausea. 2:Moderate nausea and/or vomiting.3:Severe nausea and/or vomiting.
Measured: Assessed at 15, 45, 90 minutes during PACU stay.
Percentage of Participants With Nausea and/or Vomiting in PACU
Degree of Post-Operative Nausea determined per Visual Analog Scale per nurse in Post-Anesthesia Care Unit (PACU).
Measured: Day 0 - PACU stay, an average of 120 minutes
Surgical Exposure Grading
Measured: Day 0 - IntraOperative, from incision time to closing time(average 190 minutes)
Length of Hospital Stay
Measured: length of hospital stay(average of 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start17 Nov 2017
- Primary completion30 Sep 2018
- Study completion22 Oct 2020
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 Malignant Neoplasms of Digestive OrgansStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Wendell H. Williams III, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210376
- Sponsor's protocol ID
- 2017-0046
- Other IDs
- NCI-2018-01176
- Status last verified
- Nov 2020
- First submitted
- 29 Jun 2017
- Last updated
- 25 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Williams WH 3rd, Cata JP, Lasala JD, Navai N, Feng L, Gottumukkala V. Effect of reversal of deep neuromuscular block with sugammadex or moderate block by neostigmine on shoulder pain in elderly patients undergoing robotic prostatectomy. Br J Anaesth. 2020 Feb;124(2):164-172. doi: 10.1016/j.bja.2019.09.043. Epub 2019 Nov 26.
PubMed 31780139
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Deep Neuromuscular Blockade With Sugammadex Reversal on Shoulder Pain of Elderly Patients Undergoing Robotic Surgery: A Single-Center Double-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03210376
- Acronym / sponsor ID
- 2017-0046
- Conditions
- Malignant Neoplasms of Digestive Organs, Malignant Neoplasms of Female Genital Organs, Malignant Neoplasms of Male Genital Organs, Malignant Neoplasms of Urinary Tract
- Keywords
- Malignant neoplasms of digestive organs, Malignant neoplasms of female genital organs, Malignant neoplasms of male genital organs, Malignant neoplasms of urinary tract, Neuromuscular blockade, NMB, Sugammadex, Neostigmine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 22 Oct 2020 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Posted 7 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Insufflation pressure (IP) is the creation of a pressure barrier of air/gas within the abdomen to allow the surgeon more space to work during abdominal surgery. Shoulder pain is a common complaint from patients who have had abdominal surgery and the pain is thought to be related to the use of IP.
In addition to anesthesia (which keeps you asleep during surgery), the current standard practice is to block the nerve-muscle junction with a type of drug called neuromuscular blockade (NMB) which paralyzes the abdominal muscles. This means that a lower level of insufflation pressure is needed by the surgeon.
To reverse the effects of NMB after surgery, a drug called neostigmine is given.
The goal of this clinical research study is to compare the use of standard-of-care moderate NMB and neostigmine to the use of deep NMB and a drug called Sugammadex when given to elderly patients (patients who are 65 years of age or older) who are scheduled to have robotic abdominal surgery. "Deep" and "moderate" in this study refers to the dose or strength of the NMB given.
This is an investigational study. Sugammadex and neostigmine are FDA approved and commercially available for the reversal of NMB. It is considered investigational to compare Sugammadex and neostigmine to learn if the use of one or the other in elderly patients can reduce the level of shoulder pain after surgery.
Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.
Detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups before your surgery. This is done because no one knows if one group is better, the same, or worse than the other.
- In Group 1, you will receive deep NMB and Sugammadex.
- In Group 2, you will receive moderate NMB and neostigmine.
Neither you nor the surgeon or surgical staff will know to which group you have been assigned. The surgeon will not know which group you are in because researchers want to learn how much, if at all, the surgeon needs to adjust the insufflation pressure during surgery. However, if needed for your safety, the surgeon will be able to find out which group you are in.
For your safety, the anesthesiologist will know to which group you have been assigned.
Surgery and Study Drug Administration:
After you have been assigned to a study group, you will have your surgery as scheduled. You will sign a separate consent form for surgery which describes the procedure and its risks in more detail. You will also sign a separate consent form to receive anesthesia.
Before your surgery, blood (about 2 teaspoons) will be drawn for biomarker testing. Biomarkers are found in the blood/tissue and may be related to the status of the disease and/or your reaction to the study drug(s).
During the surgery, the insufflation pressure that is being used, including any changes that are made to the pressure, will be recorded. After the surgery has been completed, you will receive either Sugammadex or neostigmine by vein until the effects of the NMB have been reversed.
You will recover after surgery in the post-anesthesia care unit (PACU). At about 15, 45, and 90 minutes after your surgery, a PACU nurse will ask you about any shoulder pain you are feeling and if so, how intense the pain is. Information about how long you stay in the hospital after surgery and if you have any side effects after surgery (such as nausea/vomiting or shoulder pain) will also be collected from your medical record.
Follow-Up:
After 30 days after you leave the hospital, you will be called by a member of the study staff to ask how you are doing and if you have had any additional hospitalizations since leaving the hospital. This phone call should last about 5-10 minutes.
Length of Study Participation:
Your participation in this study will be over after completing the 30-day follow up phone call.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep Neuromuscular Blockade (NMB) + Sugammadex | Experimental | Drug: Deep Neuromuscular Blockade (NMB), Drug: Sugammadex, Behavioral: Pain AssessmentDeep Neuromuscular Blockade (NMB) given during surgery. Sugammadex intravenously as a single bolus injection after surgery. Pain assessment done at about 15, 45, and 90 minutes after surgery. |
| Moderate Neuromuscular Blockade (NMB) + Neostigmine | Experimental | Drug: Moderate Neuromuscular Blockade (NMB), Drug: Neostigmine, Behavioral: Pain AssessmentModerate Neuromuscular Blockade (NMB) given during surgery. Neostigmine intravenously slowly over a period of at least 1 minute after surgery. Pain assessment done at about 15, 45, and 90 minutes after surgery. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients 65 years of age or older
- Patients having robotic prostatectomy
- Written informed consent
Key exclusion criteria (3 listed)
- Patient with known hypersensitivity to Rocuronium, Sugammadex or its components
- Patients with severe renal insufficiency, defined and confirmed by an estimated creatinine clearance equal or lower than 30 mL/min, per institutional laboratory.
- Patients with history of severe liver disease, defined as and confirmed by elevated ALT and AST greater than 1.5 times the Upper Limit of Normal along with Albumin less than 3 OR INR 1.5 or greater per institutional laboratory.
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 |
|---|---|---|
| Deep Neuromuscular Blockade (NMB)Deep Neuromuscular Blockade (NMB) given during surgery. | Drug | Deep Neuromuscular Blockade (NMB) + Sugammadex |
| Moderate Neuromuscular Blockade (NMB)Moderate Neuromuscular Blockade (NMB) given during surgery. | Drug | Moderate Neuromuscular Blockade (NMB) + Neostigmine |
| Sugammadex4 mg/Kg, intravenously as a single bolus injection after surgery. | Drug | Deep Neuromuscular Blockade (NMB) + Sugammadex |
| Neostigmine70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute after surgery. | Drug | Moderate Neuromuscular Blockade (NMB) + Neostigmine |
| Pain AssessmentAlso: SurveyPain assessment done at about 15, 45, and 90 minutes after surgery. | Behavioural | Deep Neuromuscular Blockade (NMB) + Sugammadex, Moderate Neuromuscular Blockade (NMB) + Neostigmine |
Primary outcome
Percentage of Patients Who Reported Shoulder Pain
Time frame: 30 days
Visual Analog Scale (VAS) pain score (0-10) for shoulder pain recorded, where 0 means no pain and 10 means the worst pain ever experienced . Percentage of participants who experienced should pain.
6 secondary outcomes
Cumulative Intraoperative Insufflation Pressure
Time frame: Day 0 - IntraOperative-From beginning of pneumoperitoneum to desufflation (an average of 166 minutes)
Percentage of Muscle Response Using Train-of-Four (TOF) in Post-Anesthesia Care Unit (PACU) to Measure Residual Muscle Relaxation
Time frame: Day 0 - Arrival time at PACU, an average of 3 minutes
Readiness to Discharge From the Post-Anesthesia Care Unit (PACU)
Time frame: Assessed at 15, 45, 90 minutes during PACU stay.
Percentage of Participants With Nausea and/or Vomiting in PACU
Time frame: Day 0 - PACU stay, an average of 120 minutes
Surgical Exposure Grading
Time frame: Day 0 - IntraOperative, from incision time to closing time(average 190 minutes)
Length of Hospital Stay
Time frame: length of hospital stay(average of 3 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31780139Williams WH 3rd, Cata JP, Lasala JD, Navai N, Feng L, Gottumukkala V. Effect of reversal of deep neuromuscular block with sugammadex or moderate block by neostigmine on shoulder pain in elderly patients undergoing robotic prostatectomy. Br J Anaesth. 2020 Feb;124(2):164-172. doi: 10.1016/j.bja.2019.09.043. Epub 2019 Nov 26.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Wendell H. Williams III, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Deep Neuromuscular Blockade (NMB), Moderate Neuromuscular Blockade (NMB) and Sugammadex in people with Malignant Neoplasms of Digestive Organs and Malignant Neoplasms of Female Genital Organs, run by M.D. Anderson Cancer Center at 1 site in United States.
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 3 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 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 7 Oct 2019). 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 Patients Who Reported Shoulder Pain (time frame: 30 days). 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 NCT03210376, 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 25 Nov 2020.