Head and Neck Squamous Cell CarcinomaPhase 1NCT01975688
A Pharmacokinetic Study of Single Doses of Sativex in Treatment-induced Mucositis
A Phase 1 study testing Sativex in people with Head and Neck Squamous Cell Carcinoma, run by GW Pharmaceuticals Ltd at 1 site in United Kingdom.
Trial summary
To investigate what the body does to single doses of Sativex (i.e. the pharmacokinetics [PKs] of four sprays containing 10.8 mg Δ9 tetrahydrocannabinol [THC] and 10 mg cannabidiol [CBD]) when mild, moderate or severe oral mucositis is induced. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Sativex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2014to Jun 2015
- Phase
- Phase 1
- 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
- Subject is willing and able to give informed consent for participation in the study.
- Male or female subjects aged 18 years or above.
- Subject is diagnosed with Stage III or Stage IV HNSCC.
- Subject is due to undergo radiotherapy of the head and/or neck with or without concomitant chemotherapy with a likelihood (in the investigator's opinion) of developing mild, moderate and severe oral mucositis.
- Subject is able (in the investigator's opinion) and willing to comply with all study requirements.
- Subject is willing and able to communicate with the investigator.
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- Subject has acceptable haematological and biochemical function, in the opinion of the investigator, as demonstrated by appropriate laboratory parameter levels including liver and renal function (estimated glomerular filtration rate as measured by the Cockcroft-Gault formula >0.5 lower limit of normal, aspartate aminotransferase/alanine aminotransferase <2.5 the upper limit of normal (ULN) and bilirubin <1.5 ULN), and in the opinion of the investigator, acceptable bone marrow reserve.
- Vital signs at screening (after five minutes resting measured in the supine position) must be within the following ranges:
- Body temperature between 35.0-37.5°C ii. Systolic blood pressure, 90-150 mmHg iii. Diastolic blood pressure, 60-90 mmHg iv. Pulse rate, 40-99 beats per minute Blood pressure and pulse rate will be taken again in a standing position. After two minutes standing, there shall be no more than a 20 mmHg drop in systolic or 10 mmHg drop in diastolic blood pressure, associated with clinical manifestation of postural hypotension.
- Subject has an Eastern Co-operative Oncology Group Performance Status of 0, 1 or 2.
- Subject is willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable in individual countries.
- Subject is willing to allow his or her primary care practitioner and consultant to be notified of participation in the study.
Who cannot join
- Subjects undergoing chemotherapy only.
- Subjects with cancer other than HNSCC as the primary tumour.
- Subjects who have undergone reconstructive oral surgery for HNSCC (within the last eight weeks).
- Subjects with RTOG Grade 4 oral mucositis (necrosis or deep ulceration, with or without bleeding).
- Subjects requiring hospital admission or extended hospitalisation for total parenteral nutrition, intravenous analgesia and/or intravenous antibiotics for the treatment of oral mucositis.
- Subjects with aphthous stomatitis, herpetic mucositis, oral thrush, denture/oral trauma, gangrenous stomatitis, acute necrotising stomatitis or other oral condition that may in the opinion of the investigator affect the oromucosal absorption of Sativex® in the absence of oral mucositis.
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- Any surgical or medical condition, significant disease or disorder or any finding on physical examination (or oral examination) (other than their underlying condition) which might significantly alter the absorption, distribution, metabolism or excretion of drugs or that, in the opinion of the investigator, may put the subject at risk, influence the result of the study, or the subjects' ability to participate in the study.
- Clinical evidence of acute or chronic liver disease or liver injury as indicated by clinically significant abnormal liver function tests such as aspartate aminotransferase, alanine aminotransferase, gamma glutamyl-transpeptidase, alkaline phosphatase, (any ≥2.5 ULN ) or serum bilirubin (≥1.5 ULN) unless there is another more likely explanation (e.g. Gilbert's syndrome).
- Any change in medication within 14 days prior to dosing and throughout the study which might significantly alter the absorption, distribution, metabolism or excretion of the investigational medicinal product (IMP), in the opinion of the investigator.
- History of drug abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
- Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP(s).
- Positive result for the presence of hepatitis B surface antigen, hepatitis C virus antibodies, or human immunodeficiency virus antibodies.
- Currently using or has used cannabis, cannabinoid-based medications (e.g. Marinol®, Nabilone®, Cannador®) or Acomplia® (rimonabant) or taranabant within 30 days of study entry and unwilling to abstain for the duration of the study.
- Any known or suspected history or family history of schizophrenia, or other psychotic illness, history of severe personality disorder or other severe significant psychiatric disorder other than depression associated with underlying condition.
- Any history of epilepsy as evidenced by one or more seizures in the last 12 months.
- Significant cardiac disease, or has a cardiac disorder that in the opinion of the investigator would put the subject at risk of a clinically relevant arrhythmia or myocardial infarction, or has a secondary or tertiary atrioventricular block, or evidence of clinically significant cardiac disease on electrocardiogram at screening.
- Female subjects of child bearing potential and male subjects whose partner is of child bearing potential, unless willing to ensure that they or their partner use two effective forms of contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (Note: a male condom should not be used in conjunction with a female condom).
- Female subjects who are pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
- Subjects who have received an IMP within the 12 weeks prior to the screening visit.
- Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the result of the study, or the subject's ability to participate in the study.
- Following a physical examination, the subject has any abnormalities that, in the opinion of the investigator would prevent the subject from safe participation in the study.
- Unwilling to abstain from donation of blood during the study.
- Travel outside the country of residence planned during the study.
- Subjects previously enrolled into this study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quintiles London Drug Research Unit
London, SE1 1YR
About this study
Official title: An Open-label Clinical Trial to Compare the Pharmacokinetics of up to 4 Single Oromucosal Doses of 4 Sprays of Sativex® in Patients With Treatment Induced Mild, Moderate and Severe Oral Mucositis (Grade 1 - 3 RTOG Oral Mucositis) With Their Pharmacokinetic Profile Pre-treatment (When Mucositis-free)
To investigate what the body does to single doses of Sativex (i.e. the pharmacokinetics [PKs] of four sprays containing 10.8 mg Δ9 tetrahydrocannabinol [THC] and 10 mg cannabidiol [CBD]) when mild, moderate or severe oral mucositis is induced. This will be done by looking at the effects of the body on the drug before and after oral mucositis is induced. The study participants will have Non-surgical Head and Neck Squamous Cell Carcinoma (HNSCC), and oral mucositis will be induced with radiotherapy and/or chemotherapy.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Sativex
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SativexDrug
Also called THC/CBD spray, Nabiximols, GW-1000-02
Oromucosal spray containing THC (27 mg/mL) and CBD (25 mg/mL) in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring.
Each vial contains 10 mL; each 100 uL actuation delivers 2.7 mg THC and 2.5 mg CBD.
| Study group | Role | What they receive |
|---|---|---|
| Sativex: pre-treatment (Grade 0) | Experimental | The PKs of a single dose of Sativex are investigated in subjects with mucositis of Radiation Therapy Oncology Group (RTOG) Grade 0 (i.e. at baseline, pre-induction of mucositis). Receives: Drug: Sativex |
| Sativex: mild mucositis (Grade 1) | Experimental | The PKs of a single dose of Sativex are investigated in the same subjects when their mucositis is RTOG is Grade 1 (mild). Receives: Drug: Sativex |
| Sativex: moderate mucositis (Grade 2) | Experimental | The PKs of a single dose of Sativex are investigated in the same subjects when their mucositis is RTOG is Grade 2 (moderate). Receives: Drug: Sativex |
| Sativex: severe mucositis (Grade 3) | Experimental | The PKs of a single dose of Sativex are investigated in the same subjects when their mucositis is RTOG is Grade 3 (severe). Receives: Drug: Sativex |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to peak plasma concentration (Cmax) of THC, 11-hydroxy-THC, CBD, 7-hydroxy-CBD and 6-hydroxy-CBD after a single dose of Sativex
Blood samples for PK analysis were taken at pre-defined time-points by either direct venipuncture or an indwelling cannula inserted in a forearm vein. Blood was drawn from each subject into a five-mL lithium-heparinised tube. The allowable window for sample collection was ±5 minutes at all PK time points with the exception of 8 hours (window of ±1 hour) and 24 hours (±2 hours).
Measured: Pre-dose then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose
Area under the concentration-time curve from administration until the last sampling point (t) equal or above the Lower Limit of Quantification (AUC(0-t)) of THC, 11-hydroxy-THC, CBD, 7-hydroxy-CBD and 6-hydroxy-CBD after a single dose of Sativex
Blood samples for PK analysis were taken at pre-defined time-points by either direct venipuncture or an indwelling cannula inserted in a forearm vein. Blood was drawn from each subject into a five-mL lithium-heparinised tube. The allowable window for sample collection was ±5 minutes at all PK time points with the exception of 8 hours (window of ±1 hour) and 24 hours (±2 hours).
Measured: Pre-dose then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose
Area under the concentration-time curve extrapolated to infinity (AUC(0-∞)) of THC, 11-hydroxy-THC, CBD, 7-hydroxy-CBD and 6-hydroxy-CBD after a single dose of Sativex
Blood samples for PK analysis were taken at pre-defined time-points by either direct venipuncture or an indwelling cannula inserted in a forearm vein. Blood was drawn from each subject into a five-mL lithium-heparinised tube. The allowable window for sample collection was ±5 minutes at all PK time points with the exception of 8 hours (window of ±1 hour) and 24 hours (±2 hours).
Measured: Pre-dose then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose
Secondary outcomes (4)
Median time to maximum plasma concentration (Tmax) of THC, 11-hydroxy-THC, CBD, 7-hydroxy-CBD and 6-hydroxy-CBD after a single dose of Sativex
Blood samples for PK analysis were taken at pre-defined time-points by either direct venipuncture or an indwelling cannula inserted in a forearm vein. Blood was drawn from each subject into a five-mL lithium-heparinised tube. The allowable window for sample collection was ±5 minutes at all PK time points with the exception of 8 hours (window of ±1 hour) and 24 hours (±2 hours).
Measured: Pre-dose then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose
Terminal half-life (t1/2) of THC, 11-hydroxy-THC, CBD, 7-hydroxy-CBD and 6-hydroxy-CBD after a single dose of Sativex
Blood samples for PK analysis were taken at pre-defined time-points by either direct venipuncture or an indwelling cannula inserted in a forearm vein. Blood was drawn from each subject into a five-mL lithium-heparinised tube. The allowable window for sample collection was ±5 minutes at all PK time points with the exception of 8 hours (window of ±1 hour) and 24 hours (±2 hours).
Measured: Pre-dose then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose
Apparent total body clearance of drug from plasma (CL/F) of THC, 11-hydroxy-THC, CBD, 7-hydroxy-CBD and 6-hydroxy-CBD after a single dose of Sativex
Blood samples for PK analysis were taken at pre-defined time-points by either direct venipuncture or an indwelling cannula inserted in a forearm vein. Blood was drawn from each subject into a five-mL lithium-heparinised tube. The allowable window for sample collection was ±5 minutes at all PK time points with the exception of 8 hours (window of ±1 hour) and 24 hours (±2 hours).
Measured: Pre-dose then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose
The incidence of adverse events as a measure of subject safety
The numbers of subjects who experienced an adverse event during the study is presented.
Measured: Day 1 - Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2013 (estimated)
- Study startFeb 2014
- Primary completionMar 2015
- Study completionJun 2015
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- GW Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Ritter, DPhil FRCP FMedSci, Study chair, Quintiles Drug Research Unit at Guy's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975688
- Sponsor's protocol ID
- GWCP10115
- Status last verified
- Aug 2016
- First submitted
- 29 Oct 2013
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Clinical Trial to Compare the Pharmacokinetics of up to 4 Single Oromucosal Doses of 4 Sprays of Sativex® in Patients With Treatment Induced Mild, Moderate and Severe Oral Mucositis (Grade 1 - 3 RTOG Oral Mucositis) With Their Pharmacokinetic Profile Pre-treatment (When Mucositis-free)
- ClinicalTrials.gov ID
- NCT01975688
- Acronym / sponsor ID
- GWCP10115
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- GW Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 5 Nov 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.
To investigate what the body does to single doses of Sativex (i.e. the pharmacokinetics [PKs] of four sprays containing 10.8 mg Δ9 tetrahydrocannabinol [THC] and 10 mg cannabidiol [CBD]) when mild, moderate or severe oral mucositis is induced. This will be done by looking at the effects of the body on the drug before and after oral mucositis is induced. The study participants will have Non-surgical Head and Neck Squamous Cell Carcinoma (HNSCC), and oral mucositis will be induced with radiotherapy and/or chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sativex: pre-treatment (Grade 0) | Experimental | Drug: SativexThe PKs of a single dose of Sativex are investigated in subjects with mucositis of Radiation Therapy Oncology Group (RTOG) Grade 0 (i.e. at baseline, pre-induction of mucositis). |
| Sativex: mild mucositis (Grade 1) | Experimental | Drug: SativexThe PKs of a single dose of Sativex are investigated in the same subjects when their mucositis is RTOG is Grade 1 (mild). |
| Sativex: moderate mucositis (Grade 2) | Experimental | Drug: SativexThe PKs of a single dose of Sativex are investigated in the same subjects when their mucositis is RTOG is Grade 2 (moderate). |
| Sativex: severe mucositis (Grade 3) | Experimental | Drug: SativexThe PKs of a single dose of Sativex are investigated in the same subjects when their mucositis is RTOG is Grade 3 (severe). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject is willing and able to give informed consent for participation in the study.
- Male or female subjects aged 18 years or above.
- Subject is diagnosed with Stage III or Stage IV HNSCC.
- Subject is due to undergo radiotherapy of the head and/or neck with or without concomitant chemotherapy with a likelihood (in the investigator's opinion) of developing mild, moderate and severe oral mucositis.
- Subject is able (in the investigator's opinion) and willing to comply with all study requirements.
Key exclusion criteria (24 listed)
- Subjects undergoing chemotherapy only.
- Subjects with cancer other than HNSCC as the primary tumour.
- Subjects who have undergone reconstructive oral surgery for HNSCC (within the last eight weeks).
- Subjects with RTOG Grade 4 oral mucositis (necrosis or deep ulceration, with or without bleeding).
- Subjects requiring hospital admission or extended hospitalisation for total parenteral nutrition, intravenous analgesia and/or intravenous antibiotics for the treatment of oral mucositis.
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 |
|---|---|---|
| SativexAlso: THC/CBD spray, Nabiximols, GW-1000-02Oromucosal spray containing THC (27 mg/mL) and CBD (25 mg/mL) in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Each vial contains 10 mL; each 100 uL actuation delivers 2.7 mg THC and 2.5 mg CBD. | Drug | Sativex: mild mucositis (Grade 1), Sativex: moderate mucositis (Grade 2), Sativex: pre-treatment (Grade 0), Sativex: severe mucositis (Grade 3) |
Primary outcome
The time to peak plasma concentration (Cmax) of THC, 11-hydroxy-THC, CBD, 7-hydroxy-CBD and 6-hydroxy-CBD after a single dose of Sativex
Time frame: Pre-dose then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose
Blood samples for PK analysis were taken at pre-defined time-points by either direct venipuncture or an indwelling cannula inserted in a forearm vein. Blood was drawn from each subject into a five-mL lithium-heparinised tube. The allowable window for sample collection was ±5 minutes at all PK time points with the exception of 8 hours (window of ±1 hour) and 24 hours (±2 hours).
Area under the concentration-time curve from administration until the last sampling point (t) equal or above the Lower Limit of Quantification (AUC(0-t)) of THC, 11-hydroxy-THC, CBD, 7-hydroxy-CBD and 6-hydroxy-CBD after a single dose of Sativex
Time frame: Pre-dose then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose
Blood samples for PK analysis were taken at pre-defined time-points by either direct venipuncture or an indwelling cannula inserted in a forearm vein. Blood was drawn from each subject into a five-mL lithium-heparinised tube. The allowable window for sample collection was ±5 minutes at all PK time points with the exception of 8 hours (window of ±1 hour) and 24 hours (±2 hours).
Area under the concentration-time curve extrapolated to infinity (AUC(0-∞)) of THC, 11-hydroxy-THC, CBD, 7-hydroxy-CBD and 6-hydroxy-CBD after a single dose of Sativex
Time frame: Pre-dose then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose
Blood samples for PK analysis were taken at pre-defined time-points by either direct venipuncture or an indwelling cannula inserted in a forearm vein. Blood was drawn from each subject into a five-mL lithium-heparinised tube. The allowable window for sample collection was ±5 minutes at all PK time points with the exception of 8 hours (window of ±1 hour) and 24 hours (±2 hours).
4 secondary outcomes
Median time to maximum plasma concentration (Tmax) of THC, 11-hydroxy-THC, CBD, 7-hydroxy-CBD and 6-hydroxy-CBD after a single dose of Sativex
Time frame: Pre-dose then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose
Terminal half-life (t1/2) of THC, 11-hydroxy-THC, CBD, 7-hydroxy-CBD and 6-hydroxy-CBD after a single dose of Sativex
Time frame: Pre-dose then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose
Apparent total body clearance of drug from plasma (CL/F) of THC, 11-hydroxy-THC, CBD, 7-hydroxy-CBD and 6-hydroxy-CBD after a single dose of Sativex
Time frame: Pre-dose then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose
The incidence of adverse events as a measure of subject safety
Time frame: Day 1 - Day 30
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
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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.
James Ritter, DPhil FRCP FMedSci study chair
Quintiles Drug Research Unit at Guy's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sativex in people with Head and Neck Squamous Cell Carcinoma, run by GW Pharmaceuticals Ltd 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 12 inclusion and 24 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: stopped early, as of the sponsor's last update on 11 Aug 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Slow recruitment). Results are not available in the source record.
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?
The time to peak plasma concentration (Cmax) of THC, 11-hydroxy-THC, CBD, 7-hydroxy-CBD and 6-hydroxy-CBD after a single dose of Sativex (time frame: Pre-dose then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2016.