HealthyPhase 1NCT02307864
Study to Evaluate the Effects of Tramadol Hydrochloride on Cardiac Repolarization in Healthy Participants
A Phase 1 study testing Tramadol HCl and Moxifloxacin 400 mg in people with Healthy, run by Janssen Scientific Affairs, LLC at 1 site in United States.
Trial summary
The purpose of this study is to assess the effects of multiple doses of an immediate release (IR) formulation of tramadol hydrochloride (HCl) at therapeutic and supratherapeutic levels in healthy adult participants on the electrocardiogram (ECG) QT interval corrected for heart rate (QTc). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tramadol HCl and Moxifloxacin 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2014to 27 Aug 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Woman participant of child-bearing potential, must have a negative serum beta-human chorionic gonadotropin pregnancy test at Screening; and a negative urine pregnancy test on Day 1 of each treatment period
- Standard electroencephalogram (EEG) that is normal, as assessed by a neurologist. The EEG will be performed under basic conditions and during hyperventilation and intermittent photic stimulation at Screening
- Body mass index (BMI; weight [in kilogram]/height [in square meter]) between 18 and 30 kilogram per square meter (inclusive), and body weight not less than 50 kilogram at Screening
- Blood pressure between 90 and 140 millimeter of mercury (mm Hg) systolic (inclusive) and no higher than 90 mm Hg diastolic
- An average of triplicate 12-lead electrocardiogram (ECG) recordings (performed in a semi-supine position), completed within 4 minutes total, consistent with normal cardiac conduction and function at Screening, including: 1- Sinus rhythm with heart rate between 40 and 100 beats per minute (inclusive); 2- QTc interval between 350 to 450 milliseconds (inclusive); 3- QRS interval of less than 110 milliseconds; 4- PR interval less than 200 milliseconds; 5- ECG morphology consistent with healthy cardiac conduction and function
Who cannot join
- Personal or family history of epileptic seizures or convulsions (genetic or idiopathic seizures), or have suffered from head trauma with loss of consciousness, central nervous system infection, or loss of consciousness of unknown origin
- History of additional risk factors for torsades de pointes (TdP) or the presence of a family history of short QT syndrome, long QT syndrome, sudden unexplained death at a young age ( less than equal to 40 years), drowning or sudden infant death syndrome in a first degree relative (that is, biological parent, sibling, or child)
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at Screening or before the first dose of study drug on Day -1 of each treatment period as assessed by the Investigator. Note that participants who have serum potassium, magnesium, or calcium levels outside of the local laboratory's reference range will be excluded
- Clinically significant abnormal physical examination or vital signs at Screening or before the first dose of study drug on Day -1 of each treatment period as assessed by the Investigator
- History of drug or alcohol abuse within 5 years before Screening or positive test result(s) for alcohol or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines, hallucinogens, and benzodiazepines) at Screening or on Day -1 of each treatment period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo- and Positive-Controlled, Multiple Dose, Four Way Crossover Study to Evaluate the Effects of Tramadol Hydrochloride on Cardiac Repolarization in Healthy Subjects at Therapeutic and Supratherapeutic Dose Levels
The purpose of this study is to assess the effects of multiple doses of an immediate release (IR) formulation of tramadol hydrochloride (HCl) at therapeutic and supratherapeutic levels in healthy adult participants on the electrocardiogram (ECG) QT interval corrected for heart rate (QTc).
Read the detailed description
This is a randomized (study medication assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), 4-way crossover (method used to switch participants from one treatment arm to another), placebo- and positive-controlled (the experimental treatment or procedure is compared to an inactive substance and a standard treatment or procedure), single site, multiple dose study. The study has 3 phases: a Screening Phase (up to 35 days); a Double-blind Treatment Phase (4 treatment periods with a washout period of 7 to 15 days); and a Post-treatment Phase (Day 5 of Period 4 or at the time of early withdrawal). All eligible participants will receive each of the 4 treatments: tramadol HCl at therapeutic dose of 400 milligram per day (mg/day), tramadol HCl at supratherapeutic dose of 600 mg/day, placebo, and positive control moxifloxacin 400 mg; in any of the treatment period as per assigned treatment sequence. The total duration of each participant's participation will be up to a maximum of 100 days. Participants' safety will be monitored throughout the study.
- Conditions
- Healthy
- Being tested
- Tramadol HCl, Moxifloxacin 400 mg, Tramadol HCl Placebo, Moxifloxacin Placebo
- Keywords
- Healthy, QT interval, QTc interval, Electrocardiogram, Tramadol hydrochloride, Moxifloxacin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol HClDrug
Also called RWJ-26898-002
Tramadol HCl 50 mg immediate release (IR) tablet administered orally.
Moxifloxacin 400 mgDrug
Also called Avelox
Moxifloxacin 400 mg tablet administered orally.
Tramadol HCl PlaceboDrug
Placebo matched to tramadol HCl IR tablet administered orally.
Moxifloxacin PlaceboDrug
Placebo matched to Moxifloxacin 400 mg tablet administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence 1 | Experimental | Participants will receive treatment A (2*50 milligram [mg] tramadol hydrochloride [HCl] immediate release [IR] tablet + 1 tramadol HCl placebo every 6 hours on Days 1, 2, and 3, along with single dose of 2*50 mg tramadol HCl IR tablet + 1 tramadol HCl placebo + 1 moxifloxacin placebo on Day 4); treatment B (3*50 mg tramadol HCl IR tablet every 6 hours on Days 1, 2, and 3, along with single dose of 3*50 mg tramadol HCl IR tablet + 1 moxifloxacin placebo on Day 4); treatment C (3 tramadol HCl placebo every 6 hours on Days 1, 2, and 3, along with single dose of 3 tramadol HCl placebo + 1 moxifloxacin placebo on Day 4); and treatment D (3 tramadol HCl placebo every 6 hours on Days 1, 2, and 3, along with single dose of 3 tramadol HCl placebo + 1 moxifloxacin placebo on Day 4) in 4 treatment periods as per protocol defined sequence. A washout period of 7 to 15 days will be maintained between each treatment period. Receives: Drug: Tramadol HCl; Drug: Moxifloxacin 400 mg; Drug: Tramadol HCl Placebo; Drug: Moxifloxacin Placebo |
| Treatment Sequence 2 | Experimental | Participants will receive treatment A; treatment B; treatment C; and treatment D in 4 treatment periods as per protocol defined sequence. A washout period of 7 to 15 days will be maintained between each treatment period. Receives: Drug: Tramadol HCl; Drug: Moxifloxacin 400 mg; Drug: Tramadol HCl Placebo; Drug: Moxifloxacin Placebo |
| Treatment Sequence 3 | Experimental | Participants will receive treatment A; treatment B; treatment C; and treatment D in 4 treatment periods as per protocol defined sequence. A washout period of 7 to 15 days will be maintained between each treatment period. Receives: Drug: Tramadol HCl; Drug: Moxifloxacin 400 mg; Drug: Tramadol HCl Placebo; Drug: Moxifloxacin Placebo |
| Treatment Sequence 4 | Experimental | Participants will receive treatment A; treatment B; treatment C; and treatment D in 4 treatment periods as per protocol defined sequence. A washout period of 7 to 15 days will be maintained between each treatment period. Receives: Drug: Tramadol HCl; Drug: Moxifloxacin 400 mg; Drug: Tramadol HCl Placebo; Drug: Moxifloxacin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in QTc Interval
The QT interval corrected for heart rate (QTc interval) using Fridericia, Bazett and study-specific power correction methods, will be measured by electrocardiograms (ECG).
Measured: Baseline (pre-dose, Day1); pre-dose up to 24 hours post-dose on Day 4
Secondary outcomes (7)
Change From Baseline in HR, QRS, and PR Intervals
The HR, QRS, and PR Intervals, will be measured by ECG.
Measured: Baseline (pre-dose, Day1); pre-dose up to 24 hours post-dose on Day 4
Number of Participants with T-wave and U-wave Morphological Changes
The number of participants having T wave morphology changes from baseline and/or the occurrence of abnormal U-waves that represent the appearance or worsening of the morphological abnormality will be reported.
Measured: Baseline (pre-dose, Day1); pre-dose up to 24 hours post-dose on Day 4
Maximum Plasma Concentration During a Dosing Interval at Steady State (Cmax,ss)
The Cmax,ss is the maximum plasma concentration at steady state which will be observed during a dosing interval.
Measured: Pre-dose up to 24 hours post-dose on Day 4
Trough Plasma Concentration Before Dosing (pre-dose) At Steady State (Ctrough,ss)
The Ctrough,ss refers to the drug concentration at steady state, at the time when it is expected to reach its minimum (trough) concentration.
Measured: Pre-dose up to 24 hours post-dose on Day 4
Time to Reach the Maximum Plasma Concentration at Steady State (Tmax,ss)
The Tmax,ss is the time to reach maximum plasma concentration at steady state which will be observed during a dosing interval.
Measured: Pre-dose up to 24 hours post-dose on Day 4
Area Under the Plasma Concentration-Time Curve During a Dosing Interval (tau) at Steady State (AUCtau,ss)
The AUC (tau,ss) is the area under the plasma concentration time curve observed during a dosing interval (tau) at steady state.
Measured: Pre-dose up to 24 hours post-dose on Day 4
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Screening up to end of study (30 days after the last dose of study drug or early withdrawal)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study start4 Dec 2014
- Primary completion22 Aug 2015
- Study completion27 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Scientific Affairs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bausch Health Americas, Inc., Cipher Pharmaceuticals Inc.
- Responsible party
- Sponsor
- Investigators
- Janssen Scientific Affairs, LLC Clinical Trial, Study director, Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307864
- Sponsor's protocol ID
- CR106355
- Other IDs
- TRAMPAI1003, V01-TRAA-401, 2014-01-00
- Status last verified
- Aug 2018
- First submitted
- 2 Dec 2014
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Positive-Controlled, Multiple Dose, Four Way Crossover Study to Evaluate the Effects of Tramadol Hydrochloride on Cardiac Repolarization in Healthy Subjects at Therapeutic and Supratherapeutic Dose Levels
- ClinicalTrials.gov ID
- NCT02307864
- Acronym / sponsor ID
- CR106355
- Conditions
- Healthy
- Keywords
- Healthy, QT interval, QTc interval, Electrocardiogram, Tramadol hydrochloride, Moxifloxacin, Placebo
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Bausch Health Americas, Inc., Cipher Pharmaceuticals Inc.
- Study start
- 4 Dec 2014 (actual)
- Primary completion
- 22 Aug 2015 (actual)
- Study completion
- 27 Aug 2015 (actual)
- First posted
- 4 Dec 2014 (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.
The purpose of this study is to assess the effects of multiple doses of an immediate release (IR) formulation of tramadol hydrochloride (HCl) at therapeutic and supratherapeutic levels in healthy adult participants on the electrocardiogram (ECG) QT interval corrected for heart rate (QTc).
Detailed description
This is a randomized (study medication assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), 4-way crossover (method used to switch participants from one treatment arm to another), placebo- and positive-controlled (the experimental treatment or procedure is compared to an inactive substance and a standard treatment or procedure), single site, multiple dose study. The study has 3 phases: a Screening Phase (up to 35 days); a Double-blind Treatment Phase (4 treatment periods with a washout period of 7 to 15 days); and a Post-treatment Phase (Day 5 of Period 4 or at the time of early withdrawal). All eligible participants will receive each of the 4 treatments: tramadol HCl at therapeutic dose of 400 milligram per day (mg/day), tramadol HCl at supratherapeutic dose of 600 mg/day, placebo, and positive control moxifloxacin 400 mg; in any of the treatment period as per assigned treatment sequence. The total duration of each participant's participation will be up to a maximum of 100 days. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1 | Experimental | Drug: Tramadol HCl, Drug: Moxifloxacin 400 mg, Drug: Tramadol HCl Placebo, Drug: Moxifloxacin PlaceboParticipants will receive treatment A (2*50 milligram [mg] tramadol hydrochloride [HCl] immediate release [IR] tablet + 1 tramadol HCl placebo every 6 hours on Days 1, 2, and 3, along with single dose of 2*50 mg tramadol HCl IR tablet + 1 tramadol HCl placebo + 1 moxifloxacin placebo on Day 4); treatment B (3*50 mg tramadol HCl IR tablet every 6 hours on Days 1, 2, and 3, along with single dose of 3*50 mg tramadol HCl IR tablet + 1 moxifloxacin placebo on Day 4); treatment C (3 tramadol HCl placebo every 6 hours on Days 1, 2, and 3, along with single dose of 3 tramadol HCl placebo + 1 moxifloxacin placebo on Day 4); and treatment D (3 tramadol HCl placebo every 6 hours on Days 1, 2, and 3, along with single dose of 3 tramadol HCl placebo + 1 moxifloxacin placebo on Day 4) in 4 treatment periods as per protocol defined sequence. A washout period of 7 to 15 days will be maintained between each treatment period. |
| Treatment Sequence 2 | Experimental | Drug: Tramadol HCl, Drug: Moxifloxacin 400 mg, Drug: Tramadol HCl Placebo, Drug: Moxifloxacin PlaceboParticipants will receive treatment A; treatment B; treatment C; and treatment D in 4 treatment periods as per protocol defined sequence. A washout period of 7 to 15 days will be maintained between each treatment period. |
| Treatment Sequence 3 | Experimental | Drug: Tramadol HCl, Drug: Moxifloxacin 400 mg, Drug: Tramadol HCl Placebo, Drug: Moxifloxacin PlaceboParticipants will receive treatment A; treatment B; treatment C; and treatment D in 4 treatment periods as per protocol defined sequence. A washout period of 7 to 15 days will be maintained between each treatment period. |
| Treatment Sequence 4 | Experimental | Drug: Tramadol HCl, Drug: Moxifloxacin 400 mg, Drug: Tramadol HCl Placebo, Drug: Moxifloxacin PlaceboParticipants will receive treatment A; treatment B; treatment C; and treatment D in 4 treatment periods as per protocol defined sequence. A washout period of 7 to 15 days will be maintained between each treatment period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Woman participant of child-bearing potential, must have a negative serum beta-human chorionic gonadotropin pregnancy test at Screening; and a negative urine pregnancy test on Day 1 of each treatment period
- Standard electroencephalogram (EEG) that is normal, as assessed by a neurologist. The EEG will be performed under basic conditions and during hyperventilation and intermittent photic stimulation at Screening
- Body mass index (BMI; weight [in kilogram]/height [in square meter]) between 18 and 30 kilogram per square meter (inclusive), and body weight not less than 50 kilogram at Screening
- Blood pressure between 90 and 140 millimeter of mercury (mm Hg) systolic (inclusive) and no higher than 90 mm Hg diastolic
- An average of triplicate 12-lead electrocardiogram (ECG) recordings (performed in a semi-supine position), completed within 4 minutes total, consistent with normal cardiac conduction and function at Screening, including: 1- Sinus rhythm with heart rate between 40 and 100 beats per minute (inclusive); 2- QTc interval between 350 to 450 milliseconds (inclusive); 3- QRS interval of less than 110 milliseconds; 4- PR interval less than 200 milliseconds; 5- ECG morphology consistent with healthy cardiac conduction and function
Key exclusion criteria (5 listed)
- Personal or family history of epileptic seizures or convulsions (genetic or idiopathic seizures), or have suffered from head trauma with loss of consciousness, central nervous system infection, or loss of consciousness of unknown origin
- History of additional risk factors for torsades de pointes (TdP) or the presence of a family history of short QT syndrome, long QT syndrome, sudden unexplained death at a young age ( less than equal to 40 years), drowning or sudden infant death syndrome in a first degree relative (that is, biological parent, sibling, or child)
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at Screening or before the first dose of study drug on Day -1 of each treatment period as assessed by the Investigator. Note that participants who have serum potassium, magnesium, or calcium levels outside of the local laboratory's reference range will be excluded
- Clinically significant abnormal physical examination or vital signs at Screening or before the first dose of study drug on Day -1 of each treatment period as assessed by the Investigator
- History of drug or alcohol abuse within 5 years before Screening or positive test result(s) for alcohol or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines, hallucinogens, and benzodiazepines) at Screening or on Day -1 of each treatment period
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 |
|---|---|---|
| Tramadol HClAlso: RWJ-26898-002Tramadol HCl 50 mg immediate release (IR) tablet administered orally. | Drug | Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4 |
| Moxifloxacin 400 mgAlso: AveloxMoxifloxacin 400 mg tablet administered orally. | Drug | Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4 |
| Tramadol HCl PlaceboPlacebo matched to tramadol HCl IR tablet administered orally. | Drug | Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4 |
| Moxifloxacin PlaceboPlacebo matched to Moxifloxacin 400 mg tablet administered orally. | Drug | Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4 |
Primary outcome
Change From Baseline in QTc Interval
Time frame: Baseline (pre-dose, Day1); pre-dose up to 24 hours post-dose on Day 4
The QT interval corrected for heart rate (QTc interval) using Fridericia, Bazett and study-specific power correction methods, will be measured by electrocardiograms (ECG).
7 secondary outcomes
Change From Baseline in HR, QRS, and PR Intervals
Time frame: Baseline (pre-dose, Day1); pre-dose up to 24 hours post-dose on Day 4
Number of Participants with T-wave and U-wave Morphological Changes
Time frame: Baseline (pre-dose, Day1); pre-dose up to 24 hours post-dose on Day 4
Maximum Plasma Concentration During a Dosing Interval at Steady State (Cmax,ss)
Time frame: Pre-dose up to 24 hours post-dose on Day 4
Trough Plasma Concentration Before Dosing (pre-dose) At Steady State (Ctrough,ss)
Time frame: Pre-dose up to 24 hours post-dose on Day 4
Time to Reach the Maximum Plasma Concentration at Steady State (Tmax,ss)
Time frame: Pre-dose up to 24 hours post-dose on Day 4
Area Under the Plasma Concentration-Time Curve During a Dosing Interval (tau) at Steady State (AUCtau,ss)
Time frame: Pre-dose up to 24 hours post-dose on Day 4
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Screening up to end of study (30 days after the last dose of study drug or early withdrawal)
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 29 Aug 2018.
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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.
Janssen Scientific Affairs, LLC Clinical Trial study director
Janssen Scientific Affairs, LLC
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 Tramadol HCl and Moxifloxacin 400 mg in people with Healthy, run by Janssen Scientific Affairs, LLC 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 5 inclusion and 5 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 29 Aug 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 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 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 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?
Change From Baseline in QTc Interval (time frame: Baseline (pre-dose, Day1); pre-dose up to 24 hours post-dose on Day 4). 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 29 Aug 2018.