Advanced CancersPhase 2NCT01832402
Fentanyl Pectin Nasal Spray (FNPS) for Exercise-Induced Breakthrough Dyspnea
A Phase 2 study testing Fentanyl Pectin Nasal Spray, Walk Test and Questionnaires in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if fentanyl nasal spray can help to control shortness of breath in patients who have been treated or are being treated for cancer. Fentanyl is commonly used for treatment of cancer pain. It may help patients with their shortness of breath as well. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Fentanyl Pectin Nasal Spray, Walk Test and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2013to 25 Nov 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of cancer
- Breakthrough dyspnea, defined in this study as dyspnea on exertion with an average intensity level >=3/10 on the numeric rating scale
- Outpatient at MD Anderson Cancer Center seen by the Supportive Care Service or Thoracic Medical Oncology
- Ambulatory and able to walk with or without walking aid
- On strong opioids with morphine equivalent daily dose of 80-500 mg, with stable (i.e. +/- 30%) regular dose over the last 24 hours
- Karnofsky performance status >=50%
- Age 18 or older
- Able to complete study assessments
Who cannot join
- Dyspnea at rest >=7/10 at the time of enrollment
- Supplemental oxygen requirement >6 L per minute
- Delirium (i.e. Memorial delirium rating scale >13)
- History of unstable angina or myocardial infarction 1 month prior to study enrollment
- Resting heart rate >120 at the time of study enrollment
- Systolic pressure >180 mmHg or diastolic pressure >100 mmHg at the time of study enrollment
Show all 10Show fewer
- History of active opioid abuse within the past 12 months
- History of allergy to fentanyl
- Unwilling to provide informed consent
- Patients who currently have no evidence of disease
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: A Preliminary Study of Prophylactic Fentanyl Pectin Nasal Spray (FPNS) for Exercise-Induced Breakthrough Dyspnea
The goal of this clinical research study is to learn if fentanyl nasal spray can help to control shortness of breath in patients who have been treated or are being treated for cancer.
Fentanyl is commonly used for treatment of cancer pain. It may help patients with their shortness of breath as well.
In this study, fentanyl will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
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 receive either fentanyl or placebo. You will have an equal chance of being assigned to either group. Neither you nor the study staff will know to which group you have been assigned. However, if needed for your safety, the study staff will be able to find out what you are receiving.
Study Drug/Placebo Administration:
Before you receive the study drug/placebo, you will walk back and forth in an indoor hallway for up to 6 minutes. You may feel out of breath or become exhausted. You may slow down, stop, and rest at any time you need to.
After that, you will sit down and rest (for about 30 minutes).
You will then be given the study drug/placebo by a nasal spray. You will then wait for another 20 minutes and repeat the walking test.
After that, you will sit down and rest (for about 30 minutes).
You will then be given the study drug/placebo again by a nasal spray. You will then wait for another 20 minutes and repeat the walking test for a third time.
Study Visit:
During your study visit, the study staff will collect information from your medical record about your age, sex, race, disease type, your performance status, any drugs you are taking, and possible causes of shortness of breath.
Before each walk test, you will complete the questionnaires about your symptoms.
Before and after each walk test, the study staff will record your heart rate, breathing rate, and the level of oxygen in your blood using a measuring device that will be clipped onto your finger. The study staff will also ask you 3 questions about how hard it is to catch your breath and your level of tiredness.
During each walk test, you will be asked 6 times how hard it is to catch your breath. The distance you walked and how often and for how long you stopped will be recorded.
Before and after the second and third walk tests, the study staff will ask you about any side effects from the study drug/placebo that you may be having.
During the rest period between the walk tests, you may be asked several times how hard it is to catch your breath.
After each walk test, you will also be asked to complete 4 tests of your mental abilities, including finger tapping, simple mathematics questions (addition, subtraction, multiplication, division), recall of numbers, and recall of objects. It should take 15 minutes to complete these tests.
At the end of the study visit, you will complete 1 questionnaire that asks if you think the study drug/placebo is helping you, and how satisfied you are with the study. It should take about 5 minutes to complete the questionnaire.
Length of Study:
You will be on this study for up to 3 hours. You will be taken off study if intolerable side effects occur during the study.
This is an investigational study. Fentanyl is FDA approved and commercially available for the treatment of pain. Its use to help with shortness of breath is investigational.
Up to 25 patients will be enrolled in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancers
- Being tested
- Fentanyl Pectin Nasal Spray, Placebo Nasal Spray, Walk Test, Questionnaires, Mental Ability Tests
- Keywords
- Advanced Cancers, Exercise-Induced Breakthrough Dyspnea, Shortness of breath, Fentanyl pectin nasal spray, Placebo nasal spray, Walk test, Questionnaires, Surveys, Mental ability tests
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl Pectin Nasal SprayDrug
Fentanyl pectin nasal (FPNS) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test.
Placebo Nasal SprayDrug
Placebo nasal spray administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test.
Walk TestOther
Walk test administered before first dose of drug/placebo nasal spray. Participant will rest for 30 minutes after walk test. Drug/placebo nasal spray administered, then participant will wait 20 minutes before repeating second 6 minute walk test. After second walk test, participant will rest for 30 minutes. Drug/placebo nasal spray administered for second time, then participant will wait for 20 minutes. Walk test administered again for 6 minutes.
QuestionnairesBehavioural
Also called Surveys
Questionnaires completed at baseline, before each walk test, and at end of final walk test.
Mental Ability TestsBehavioural
Four mental ability tests administered after each walk test to include finger tapping, simple mathematics questions, recall of numbers, and recall of objects.
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl Pectin Nasal Spray | Experimental | Fentanyl pectin nasal (FPNS) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD). FPNS administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test. Walk test administered before first dose of FPNS. Participant will rest for 30 minutes after walk test. FPNS administered, then participant will wait 20 minutes before repeating second 6 minute walk test. After second walk test, participant will rest for 30 minutes. FPNS administered for second time, then participant will wait for 20 minutes. Walk test administered again for 6 minutes. Questionnaires completed at baseline, before each walk test, and at end of final walk test. Four mental ability tests administered after each walk test to include finger tapping, simple mathematics questions, recall of numbers, and recall of objects. Receives: Drug: Fentanyl Pectin Nasal Spray; Other: Walk Test; Behavioral: Questionnaires; Behavioral: Mental Ability Tests |
| Placebo Nasal Spray | Placebo comparator | Placebo nasal spray administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test. Walk test administered before first dose of placebo nasal spray. Participant will rest for 30 minutes after walk test. Placebo nasal spray administered, then participant will wait 20 minutes before repeating second 6 minute walk test. After second walk test, participant will rest for 30 minutes. Placebo nasal spray administered for second time, then participant will wait for 20 minutes. Walk test administered again for 6 minutes. Questionnaires completed at baseline, before each walk test, and at end of final walk test. Four mental ability tests administered after each walk test to include finger tapping, simple mathematics questions, recall of numbers, and recall of objects. Receives: Drug: Placebo Nasal Spray; Other: Walk Test; Behavioral: Questionnaires; Behavioral: Mental Ability Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea Numeric Rating Scale
Our primary outcome was dyspnea intensity "now" using a dyspnea numeric rating scale that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). Measured the mean difference of dyspnea numeric rating scale between the first and second 6 Minute Walk Tests and between the first and third 6 Minute Walk Tests. 6 minute walk tests were carried out following guidelines from the American Thoracic Society.
Measured: 1.5 to 2 hours on a Single visit
Secondary outcomes (2)
Dyspnea Borg Scale
Assessed dyspnea using the modified Dyspnea Borg Scale that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). Measured the mean difference of modified Dyspnea Borg scale between the first and second 6 Minute Walk Tests and between the first and third 6 Minute Walk Tests.
Measured: 1.5 to 2 hours on a Single visit
Walk Distance at 6 Minutes
Compared the mean difference of distance between the first and second 6 Minute Walk Tests and between the first and third 6 Minute Walk Tests.
Measured: 1.5 to 2 hours on a Single visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study start11 Jun 2013
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancersStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Depomed
- Responsible party
- Sponsor
- Investigators
- David Hui, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832402
- Sponsor's protocol ID
- 2012-1169
- Other IDs
- NCI-2013-00961
- Status last verified
- Jun 2023
- First submitted
- 10 Apr 2013
- Last updated
- 8 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hui D, Kilgore K, Park M, Williams J, Liu D, Bruera E. Impact of Prophylactic Fentanyl Pectin Nasal Spray on Exercise-Induced Episodic Dyspnea in Cancer Patients: A Double-Blind, Randomized Controlled Trial. J Pain Symptom Manage. 2016 Oct;52(4):459-468.e1. doi: 10.1016/j.jpainsymman.2016.05.013. Epub 2016 Jul 9.
PubMed 27401508
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study of Prophylactic Fentanyl Pectin Nasal Spray (FPNS) for Exercise-Induced Breakthrough Dyspnea
- ClinicalTrials.gov ID
- NCT01832402
- Acronym / sponsor ID
- 2012-1169
- Conditions
- Advanced Cancers
- Keywords
- Advanced Cancers, Exercise-Induced Breakthrough Dyspnea, Shortness of breath, Fentanyl pectin nasal spray, Placebo nasal spray, Walk test, Questionnaires, Surveys
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Depomed
- Study start
- 11 Jun 2013 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Posted 4 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if fentanyl nasal spray can help to control shortness of breath in patients who have been treated or are being treated for cancer.
Fentanyl is commonly used for treatment of cancer pain. It may help patients with their shortness of breath as well.
In this study, fentanyl will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
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 receive either fentanyl or placebo. You will have an equal chance of being assigned to either group. Neither you nor the study staff will know to which group you have been assigned. However, if needed for your safety, the study staff will be able to find out what you are receiving.
Study Drug/Placebo Administration:
Before you receive the study drug/placebo, you will walk back and forth in an indoor hallway for up to 6 minutes. You may feel out of breath or become exhausted. You may slow down, stop, and rest at any time you need to.
After that, you will sit down and rest (for about 30 minutes).
You will then be given the study drug/placebo by a nasal spray. You will then wait for another 20 minutes and repeat the walking test.
After that, you will sit down and rest (for about 30 minutes).
You will then be given the study drug/placebo again by a nasal spray. You will then wait for another 20 minutes and repeat the walking test for a third time.
Study Visit:
During your study visit, the study staff will collect information from your medical record about your age, sex, race, disease type, your performance status, any drugs you are taking, and possible causes of shortness of breath.
Before each walk test, you will complete the questionnaires about your symptoms.
Before and after each walk test, the study staff will record your heart rate, breathing rate, and the level of oxygen in your blood using a measuring device that will be clipped onto your finger. The study staff will also ask you 3 questions about how hard it is to catch your breath and your level of tiredness.
During each walk test, you will be asked 6 times how hard it is to catch your breath. The distance you walked and how often and for how long you stopped will be recorded.
Before and after the second and third walk tests, the study staff will ask you about any side effects from the study drug/placebo that you may be having.
During the rest period between the walk tests, you may be asked several times how hard it is to catch your breath.
After each walk test, you will also be asked to complete 4 tests of your mental abilities, including finger tapping, simple mathematics questions (addition, subtraction, multiplication, division), recall of numbers, and recall of objects. It should take 15 minutes to complete these tests.
At the end of the study visit, you will complete 1 questionnaire that asks if you think the study drug/placebo is helping you, and how satisfied you are with the study. It should take about 5 minutes to complete the questionnaire.
Length of Study:
You will be on this study for up to 3 hours. You will be taken off study if intolerable side effects occur during the study.
This is an investigational study. Fentanyl is FDA approved and commercially available for the treatment of pain. Its use to help with shortness of breath is investigational.
Up to 25 patients will be enrolled in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl Pectin Nasal Spray | Experimental | Drug: Fentanyl Pectin Nasal Spray, Other: Walk Test, Behavioral: Questionnaires, Behavioral: Mental Ability TestsFentanyl pectin nasal (FPNS) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD). FPNS administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test. Walk test administered before first dose of FPNS. Participant will rest for 30 minutes after walk test. FPNS administered, then participant will wait 20 minutes before repeating second 6 minute walk test. After second walk test, participant will rest for 30 minutes. FPNS administered for second time, then participant will wait for 20 minutes. Walk test administered again for 6 minutes. Questionnaires completed at baseline, before each walk test, and at end of final walk test. Four mental ability tests administered after each walk test to include finger tapping, simple mathematics questions, recall of numbers, and recall of objects. |
| Placebo Nasal Spray | Placebo comparator | Drug: Placebo Nasal Spray, Other: Walk Test, Behavioral: Questionnaires, Behavioral: Mental Ability TestsPlacebo nasal spray administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test. Walk test administered before first dose of placebo nasal spray. Participant will rest for 30 minutes after walk test. Placebo nasal spray administered, then participant will wait 20 minutes before repeating second 6 minute walk test. After second walk test, participant will rest for 30 minutes. Placebo nasal spray administered for second time, then participant will wait for 20 minutes. Walk test administered again for 6 minutes. Questionnaires completed at baseline, before each walk test, and at end of final walk test. Four mental ability tests administered after each walk test to include finger tapping, simple mathematics questions, recall of numbers, and recall of objects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of cancer
- Breakthrough dyspnea, defined in this study as dyspnea on exertion with an average intensity level >=3/10 on the numeric rating scale
- Outpatient at MD Anderson Cancer Center seen by the Supportive Care Service or Thoracic Medical Oncology
- Ambulatory and able to walk with or without walking aid
- On strong opioids with morphine equivalent daily dose of 80-500 mg, with stable (i.e. +/- 30%) regular dose over the last 24 hours
Key exclusion criteria (10 listed)
- Dyspnea at rest >=7/10 at the time of enrollment
- Supplemental oxygen requirement >6 L per minute
- Delirium (i.e. Memorial delirium rating scale >13)
- History of unstable angina or myocardial infarction 1 month prior to study enrollment
- Resting heart rate >120 at the time of study enrollment
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 |
|---|---|---|
| Fentanyl Pectin Nasal SprayFentanyl pectin nasal (FPNS) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test. | Drug | Fentanyl Pectin Nasal Spray |
| Placebo Nasal SprayPlacebo nasal spray administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test. | Drug | Placebo Nasal Spray |
| Walk TestWalk test administered before first dose of drug/placebo nasal spray. Participant will rest for 30 minutes after walk test. Drug/placebo nasal spray administered, then participant will wait 20 minutes before repeating second 6 minute walk test. After second walk test, participant will rest for 30 minutes. Drug/placebo nasal spray administered for second time, then participant will wait for 20 minutes. Walk test administered again for 6 minutes. | Other | Fentanyl Pectin Nasal Spray, Placebo Nasal Spray |
| QuestionnairesAlso: SurveysQuestionnaires completed at baseline, before each walk test, and at end of final walk test. | Behavioural | Fentanyl Pectin Nasal Spray, Placebo Nasal Spray |
| Mental Ability TestsFour mental ability tests administered after each walk test to include finger tapping, simple mathematics questions, recall of numbers, and recall of objects. | Behavioural | Fentanyl Pectin Nasal Spray, Placebo Nasal Spray |
Primary outcome
Dyspnea Numeric Rating Scale
Time frame: 1.5 to 2 hours on a Single visit
Our primary outcome was dyspnea intensity "now" using a dyspnea numeric rating scale that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). Measured the mean difference of dyspnea numeric rating scale between the first and second 6 Minute Walk Tests and between the first and third 6 Minute Walk Tests. 6 minute walk tests were carried out following guidelines from the American Thoracic Society.
2 secondary outcomes
Dyspnea Borg Scale
Time frame: 1.5 to 2 hours on a Single visit
Walk Distance at 6 Minutes
Time frame: 1.5 to 2 hours on a Single visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27401508Hui D, Kilgore K, Park M, Williams J, Liu D, Bruera E. Impact of Prophylactic Fentanyl Pectin Nasal Spray on Exercise-Induced Episodic Dyspnea in Cancer Patients: A Double-Blind, Randomized Controlled Trial. J Pain Symptom Manage. 2016 Oct;52(4):459-468.e1. doi: 10.1016/j.jpainsymman.2016.05.013. Epub 2016 Jul 9.
- 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.
David Hui, 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 2 study testing Fentanyl Pectin Nasal Spray, Walk Test and Questionnaires in people with Advanced Cancers, 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 8 inclusion and 10 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 8 Jun 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 4 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea Numeric Rating Scale (time frame: 1.5 to 2 hours on a Single visit). 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 NCT01832402, 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 8 Jun 2023.