Terminal CancerPhase 4NCT02009306
Nasal Fentanyl and Buccal Midazolam for Dying Patients
A Phase 4 study testing PecFent and Epistatus, Standard subcutaneous medication and Epistatus Alone in people with Terminal Cancer, run by Gloucestershire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
When patients are dying they become unable to take oral medication and if they develop symptoms (e.g. pain or agitation) they need to be given a subcutaneous injection of medication. If they are at home this requires that a District Nurse is called and it can take a long time (sometimes hours) for the Nurse to arrive. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Terminal Cancer
- What is being tested?
- PecFent and Epistatus, Standard subcutaneous medication and Epistatus Alone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Jan 2017to 28 Feb 2018
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult hospice in-patients fitting the following criteria will be approached to see if they are willing to participate in the study:
- diagnosis of terminal cancer and thought to have an estimated prognosis of between 1 and 2 weeks
- have capacity to consent to participation
- patients who, in the last 24 hours, have experienced at least one episode of breakthrough pain FOR ARMS 1 OR 2 (RCT) For Arm 3 must have had 1 episode of agitation necessitating the use of a benzodiazepine in the last 24 hours
- taking 60mg or more of oral morphine (or its equivalent) per 24 hours FOR ARMS 1 OR 2 (RCT) IF taking less than this dose of opioid could be enrolled in Arm 3 (Epistatus alone - change in protocol implemented 28/11/17
- have carers or family members who would be: willing to give the study medication to the patient likely to be at the hospice at least 50% of the time so that they are likely to be present to administer medication.
Who cannot join
- patients / carers / family members who in the opinion of the clinical team would be too distressed by the idea of participation
- patients with disease of the nasal/buccal mucosa preventing effective absorption of medication
- families who are unable to administer breakthrough medication e.g. problems with dexterity
- history of substance abuse - patient or carer / family.
- people who who might not adequately understand verbal explanations or written information given in English. The pilot is only recruiting 20 patients and Gloucestershire has a only a very small percentage of people who are not English speaking. It has been decided that it is not cost effective to fund translation for this pilot although this information will have to be taken into account when planning a larger study. We will capture information on the numbers of patients that may have been excluded and the languages that might have been needed.
- Participated in a medicinal trial within the last four months following the guidance from the Association of the British Pharmaceutical Industry.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sue Ryder Leckhampton Court Hospice
Cheltenham, Gloucestershire, GL53 0QJ
About this study
Official title: Can Nasal Fentanyl and Buccal Midazolam Give Better Symptom Control for Dying Patients When Compared With Standard Subcutaneous Medication? Pilot Randomised Controlled Trial and Qualitative Interview Study.
When patients are dying they become unable to take oral medication and if they develop symptoms (e.g. pain or agitation) they need to be given a subcutaneous injection of medication. If they are at home this requires that a District Nurse is called and it can take a long time (sometimes hours) for the Nurse to arrive. This can be a very stressful time for the patient and family.
There are 2 drug preparations which could potentially be given by family members in the home:
Read more
Nasal fentanyl (PecFent) Buccal midazolam (Epistatus) If these preparations helped symptoms this would give much quicker symptom control for patients and might mean the District Nurse visit was not needed.
In advance of a community based randomised trial of these modes of administration, it is important to assess the feasibility of such an approach in terms of carer acceptability and patient tolerability as well as determine appropriate sample sizes and sampling methods. There are 2 work packages which would help assess feasibility of a community trial:
- An open label randomised controlled trial comparing the use of PecFent with or without Epistatus versus standard subcutaneous breakthrough medication for the management of breakthrough pain (with or without agitation) in dying hospice patients who either remain in the hospice or go home.
- A qualitative interview study to capture the thoughts of relatives of these patients about the use of these preparations.
Read the detailed description
This will be an open-label, randomized, controlled feasibility pilot study to evaluate whether using nasal fentanyl (PecFent: 100, 200, 400 or 800 mcg) alone or in combination with buccal midazolam (Epistatus: 2.5, 5 or 10 mg) has the possibility to give better breakthrough symptom control to dying patients when compared with standard subcutaneous medication (Figure 1 A and B).
Each subject and their carers/family members will receive verbal and written information followed by signing of the Informed Consent Forms (ICFs). The study is divided into two arms. In both arms patients will receive standard regular oral or subcutaneous medication for relieving non-breakthrough symptoms. In the standard care arm, patients will receive standard as needed medication (SANM) administered orally, sublingually or subcutaneously for breakthrough symptoms. The experimental arm will consist of two stages: in Stage 1 of the study, PecFent will be given to patients in order to treat breakthrough pain instead of subcutaneous opioids. PecFent will be titrated in order to establish an effective treatment dose to manage pain. SANM administered orally, sublingually or subcutaneously will be used to treat agitation and other symptoms.
After the effective treatment dose of PecFent has been established patients will enter stage 2. Patients will not move to stage 2 if the treatment dose of PecFent is not deemed effective. Stage 2 will test a range of doses of Epistatus in terms of efficacy in treating agitation alone instead of subcutaneous midazolam (or in combination with the effective treatment dose of PecFent for pain and agitation).
SANM will be used to treat other symptoms. Assessment of effectiveness of any as needed medication will be conducted at 30 minutes from administration. If PecFent, Epistatus or a combination of both is ineffective, administration of SANM will be considered. Further opioid cannot be given within one hour but benzodiazepine can be given within 30 minutes as is standard practice in this setting. Thus, patients in the experimental arm will receive symptom relief regardless the efficacy of test drugs.
- Conditions
- Terminal Cancer
- Being tested
- PecFent and Epistatus, Standard subcutaneous medication, Epistatus Alone
- Keywords
- Palliative, Symptom control, Hospice, Opioid, Benzodiazepine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PecFent and EpistatusDrug
Also called Fentanyl and Midazolam
PecFent will be supplied by Archimedes Pharma as two strengths of nasal spray solution at 1000 or 4000 mcg/mL fentanyl (as citrate). One spray contains 100 mcg or 400 mcg fentanyl (as citrate). Each bottle contains 1.55 ml ensuring delivery of 8 sprays of 100 or 400 mcg fentanyl (as citrate). PecFent is a commercially available product and packaging will be in accordance with the manufacturing authorisations (EU/1/10/644/001, EU/1/10/644/002, EU/1/10/644/005, EU/1/10/644/003, EU/1/10/644/004, EU/1/10/644/006).
Epistatus will be supplied by Special Products Ltd. as buccal solution, packed in bottles containing solution for up to 4 x 1 ml doses, as per "Specials" licence. A pack also includes 4 x oral syringes used to administer the solution to the buccal cavity on either side of the mouth.
Standard subcutaneous medicationDrug
Also called Subcutaneous opioids and midazolam
Subcutaneous as needed medication will include:
- Opioids for pain or dyspnoea
- Diamorphine
- Oxycodone
- Fentanyl
- Benzodiazepine and / or anti-psychotic for agitation
- Midazolam
- Levomepromazine
- Haloperidol Anti-emetic for nausea
- Cyclizine
- Metoclopramide
- Haloperidol
- Levomepromazine
- Anti-secretory drug for respiratory secretions
- Glycopyrronium
- Hyoscine butylbromide
- Hyoscine hydrobromide
Epistatus AloneDrug
Also called Midazolam
Epistatus will be supplied by Special Products Ltd. as buccal solution, packed in bottles containing solution for up to 4 x 1 ml doses, as per "Specials" licence. A pack also includes 4 x oral syringes used to administer the solution to the buccal cavity on either side of the mouth.
| Study group | Role | What they receive |
|---|---|---|
| PecFent and Epistatus | Experimental | Medication administered by family / carer for symptoms Receives: Drug: PecFent and Epistatus; Drug: Standard subcutaneous medication |
| Standard subcutaneous medication | Active comparator | Standard subcutaneous medication - diamophine and / or midazolam administered by nursing staff Receives: Drug: Standard subcutaneous medication |
| Epistatus Alone | Experimental | From 28/11/17 following approval from sponsor, ethics committee and MHRA a 3rd observational arm was introduced:
Epistatus administered PRN by family / carer for symptoms Receives: Drug: Standard subcutaneous medication; Drug: Epistatus Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to adequate symptom control ('comfortable') from need for breakthrough medication (in minutes) according to patient (where possible), relatives and staff.
Data will be captured by patient and/or carer and/or staff with regard to time from need for breakthrough medication (recognition of symptom) to adequate symptom control ('comfortable').
Measured: 30 minutes
Secondary outcomes (6)
Time (in minutes) from need for breakthrough medication (recognition of symptom) to administration of drug.
Data will be captured by patient and/or carer and/or staff with regard to time from need for breakthrough medication (recognition of symptom) to administration of drug.
Measured: 30 minutes
Need for additional oral or subcutaneous medication
Data will be captured by patient and/or carer and/or staff with regard to need for additional oral or subcutaneous medication
Measured: 30 minutes
Time (in minutes) to recurrence of symptoms according to patient (where possible), relatives and staff
Data will be captured by patient and/or carer and/or staff with regard to symptoms recurring.
Measured: 4 hours
Patient comfort as measured by the modified Palliative care Outcome Scale Symptom list (POS-S) (patient /carer/ staff versions)
The modified Palliative care Outcome Scale Symptom list (POS-S) (patient /carer/ staff versions) at approximately the same time daily (depending on when family / carers are likely to be present).
For this study the Palliative care Outcome Scale Symptom list (known as POS-S) has been modified by removing the question on 'Any other symptoms' and with the addition of the anxiety question from the Integrated Palliative care Outcome Scale (IPOS).
Measured: 30 minutes
Visual analogue scales for pain and agitation completed by patient (where possible), relatives and staff at baseline (Time 0), 5, 10, 15, 20, 25 and 30 minutes for 1 breakthrough episode per day
Visual analogue scales for pain and agitation completed by patient (where possible), relatives and staff at baseline (Time X), time 0 (dose), 5, 10, 15, 20, 25 and 30 minutes (post-dose calculated from time 0) for 1 breakthrough episode per day
Measured: 30 minutes
Adverse events
Adverse event information will be collected by research staff.
Measured: 4 weeks after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study start23 Jan 2017
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
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 Terminal CancerStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gloucestershire Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Perkins, Gloucestershire Hospitals NHS Foundation Trust
- Investigators
- Paul Perkins, MB BCh FRCP (UK), Principal investigator, Gloucestershire Hospitals NHS Foundation Trust and
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009306
- Sponsor's protocol ID
- PecEp1
- Status last verified
- May 2018
- First submitted
- 18 Nov 2013
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Happy for researchers to contact us once data has been analysed and published
Publications
Perkins P, Parkinson A, Akyea RK, Husbands E. Nasal fentanyl alone plus buccal midazolam: an open-label, randomised, controlled feasibility study in the dying. BMJ Support Palliat Care. 2020 Sep;10(3):300-303. doi: 10.1136/bmjspcare-2019-002029. Epub 2020 May 6.
PubMed 32376759
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Nasal Fentanyl and Buccal Midazolam Give Better Symptom Control for Dying Patients When Compared With Standard Subcutaneous Medication? Pilot Randomised Controlled Trial and Qualitative Interview Study.
- ClinicalTrials.gov ID
- NCT02009306
- Acronym / sponsor ID
- PecEp1
- Conditions
- Terminal Cancer
- Keywords
- Palliative, Symptom control, Hospice, Opioid, Benzodiazepine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Gloucestershire Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 11 Dec 2013 (estimated)
- 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.
When patients are dying they become unable to take oral medication and if they develop symptoms (e.g. pain or agitation) they need to be given a subcutaneous injection of medication. If they are at home this requires that a District Nurse is called and it can take a long time (sometimes hours) for the Nurse to arrive. This can be a very stressful time for the patient and family.
There are 2 drug preparations which could potentially be given by family members in the home:
Nasal fentanyl (PecFent) Buccal midazolam (Epistatus) If these preparations helped symptoms this would give much quicker symptom control for patients and might mean the District Nurse visit was not needed.
In advance of a community based randomised trial of these modes of administration, it is important to assess the feasibility of such an approach in terms of carer acceptability and patient tolerability as well as determine appropriate sample sizes and sampling methods. There are 2 work packages which would help assess feasibility of a community trial:
- An open label randomised controlled trial comparing the use of PecFent with or without Epistatus versus standard subcutaneous breakthrough medication for the management of breakthrough pain (with or without agitation) in dying hospice patients who either remain in the hospice or go home.
- A qualitative interview study to capture the thoughts of relatives of these patients about the use of these preparations.
Detailed description
This will be an open-label, randomized, controlled feasibility pilot study to evaluate whether using nasal fentanyl (PecFent: 100, 200, 400 or 800 mcg) alone or in combination with buccal midazolam (Epistatus: 2.5, 5 or 10 mg) has the possibility to give better breakthrough symptom control to dying patients when compared with standard subcutaneous medication (Figure 1 A and B).
Each subject and their carers/family members will receive verbal and written information followed by signing of the Informed Consent Forms (ICFs). The study is divided into two arms. In both arms patients will receive standard regular oral or subcutaneous medication for relieving non-breakthrough symptoms. In the standard care arm, patients will receive standard as needed medication (SANM) administered orally, sublingually or subcutaneously for breakthrough symptoms. The experimental arm will consist of two stages: in Stage 1 of the study, PecFent will be given to patients in order to treat breakthrough pain instead of subcutaneous opioids. PecFent will be titrated in order to establish an effective treatment dose to manage pain. SANM administered orally, sublingually or subcutaneously will be used to treat agitation and other symptoms.
After the effective treatment dose of PecFent has been established patients will enter stage 2. Patients will not move to stage 2 if the treatment dose of PecFent is not deemed effective. Stage 2 will test a range of doses of Epistatus in terms of efficacy in treating agitation alone instead of subcutaneous midazolam (or in combination with the effective treatment dose of PecFent for pain and agitation).
SANM will be used to treat other symptoms. Assessment of effectiveness of any as needed medication will be conducted at 30 minutes from administration. If PecFent, Epistatus or a combination of both is ineffective, administration of SANM will be considered. Further opioid cannot be given within one hour but benzodiazepine can be given within 30 minutes as is standard practice in this setting. Thus, patients in the experimental arm will receive symptom relief regardless the efficacy of test drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PecFent and Epistatus | Experimental | Drug: PecFent and Epistatus, Drug: Standard subcutaneous medicationMedication administered by family / carer for symptoms |
| Standard subcutaneous medication | Active comparator | Drug: Standard subcutaneous medicationStandard subcutaneous medication - diamophine and / or midazolam administered by nursing staff |
| Epistatus Alone | Experimental | Drug: Standard subcutaneous medication, Drug: Epistatus AloneFrom 28/11/17 following approval from sponsor, ethics committee and MHRA a 3rd observational arm was introduced: Epistatus administered PRN by family / carer for symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult hospice in-patients fitting the following criteria will be approached to see if they are willing to participate in the study:
- diagnosis of terminal cancer and thought to have an estimated prognosis of between 1 and 2 weeks
- have capacity to consent to participation
- patients who, in the last 24 hours, have experienced at least one episode of breakthrough pain FOR ARMS 1 OR 2 (RCT) For Arm 3 must have had 1 episode of agitation necessitating the use of a benzodiazepine in the last 24 hours
- taking 60mg or more of oral morphine (or its equivalent) per 24 hours FOR ARMS 1 OR 2 (RCT) IF taking less than this dose of opioid could be enrolled in Arm 3 (Epistatus alone - change in protocol implemented 28/11/17
Key exclusion criteria (6 listed)
- patients / carers / family members who in the opinion of the clinical team would be too distressed by the idea of participation
- patients with disease of the nasal/buccal mucosa preventing effective absorption of medication
- families who are unable to administer breakthrough medication e.g. problems with dexterity
- history of substance abuse - patient or carer / family.
- people who who might not adequately understand verbal explanations or written information given in English. The pilot is only recruiting 20 patients and Gloucestershire has a only a very small percentage of people who are not English speaking. It has been decided that it is not cost effective to fund translation for this pilot although this information will have to be taken into account when planning a larger study. We will capture information on the numbers of patients that may have been excluded and the languages that might have been needed.
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 |
|---|---|---|
| PecFent and EpistatusAlso: Fentanyl and MidazolamPecFent will be supplied by Archimedes Pharma as two strengths of nasal spray solution at 1000 or 4000 mcg/mL fentanyl (as citrate). One spray contains 100 mcg or 400 mcg fentanyl (as citrate). Each bottle contains 1.55 ml ensuring delivery of 8 sprays of 100 or 400 mcg fentanyl (as citrate). PecFent is a commercially available product and packaging will be in accordance with the manufacturing authorisations (EU/1/10/644/001, EU/1/10/644/002, EU/1/10/644/005, EU/1/10/644/003, EU/1/10/644/004, EU/1/10/644/006). Epistatus will be supplied by Special Products Ltd. as buccal solution, packed in bottles containing solution for up to 4 x 1 ml doses, as per "Specials" licence. A pack also includes 4 x oral syringes used to administer the solution to the buccal cavity on either side of the mouth. | Drug | PecFent and Epistatus |
| Standard subcutaneous medicationAlso: Subcutaneous opioids and midazolamSubcutaneous as needed medication will include: * Opioids for pain or dyspnoea * Diamorphine * Oxycodone * Fentanyl * Benzodiazepine and / or anti-psychotic for agitation * Midazolam * Levomepromazine * Haloperidol Anti-emetic for nausea * Cyclizine * Metoclopramide * Haloperidol * Levomepromazine * Anti-secretory drug for respiratory secretions * Glycopyrronium * Hyoscine butylbromide * Hyoscine hydrobromide | Drug | Epistatus Alone, PecFent and Epistatus, Standard subcutaneous medication |
| Epistatus AloneAlso: MidazolamEpistatus will be supplied by Special Products Ltd. as buccal solution, packed in bottles containing solution for up to 4 x 1 ml doses, as per "Specials" licence. A pack also includes 4 x oral syringes used to administer the solution to the buccal cavity on either side of the mouth. | Drug | Epistatus Alone |
Primary outcome
Time to adequate symptom control ('comfortable') from need for breakthrough medication (in minutes) according to patient (where possible), relatives and staff.
Time frame: 30 minutes
Data will be captured by patient and/or carer and/or staff with regard to time from need for breakthrough medication (recognition of symptom) to adequate symptom control ('comfortable').
6 secondary outcomes
Time (in minutes) from need for breakthrough medication (recognition of symptom) to administration of drug.
Time frame: 30 minutes
Need for additional oral or subcutaneous medication
Time frame: 30 minutes
Time (in minutes) to recurrence of symptoms according to patient (where possible), relatives and staff
Time frame: 4 hours
Patient comfort as measured by the modified Palliative care Outcome Scale Symptom list (POS-S) (patient /carer/ staff versions)
Time frame: 30 minutes
Visual analogue scales for pain and agitation completed by patient (where possible), relatives and staff at baseline (Time 0), 5, 10, 15, 20, 25 and 30 minutes for 1 breakthrough episode per day
Time frame: 30 minutes
Adverse events
Time frame: 4 weeks after enrolment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Derived from this study: PubMed 32376759Perkins P, Parkinson A, Akyea RK, Husbands E. Nasal fentanyl alone plus buccal midazolam: an open-label, randomised, controlled feasibility study in the dying. BMJ Support Palliat Care. 2020 Sep;10(3):300-303. doi: 10.1136/bmjspcare-2019-002029. Epub 2020 May 6.
- Individual participant dataSharing planned: Yes. Happy for researchers to contact us once data has been analysed and published
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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.
Paul Perkins, MB BCh FRCP (UK) principal investigator
Gloucestershire Hospitals NHS Foundation Trust and
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 PecFent and Epistatus, Standard subcutaneous medication and Epistatus Alone in people with Terminal Cancer, run by Gloucestershire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 6 inclusion and 6 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 9 May 2018. 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 Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to adequate symptom control ('comfortable') from need for breakthrough medication (in minutes) according to patient (where possible), relatives and staff. (time frame: 30 minutes). 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 NCT02009306, 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 9 May 2018.