Alcohol-Related DisordersPhase 1AEDEDNCT02771587
Interaction of Alcohol With Energy Drinks
A Phase 1 study testing Alcohol and energy drink, Alcohol and Energy drink in people with Alcohol-Related Disorders and Drinking and Driving, run by Parc de Salut Mar at 2 sites in Spain.
Trial summary
The main objective of the project is to assess whether there is an interaction between the effects of ethanol and energy drinks on driving performance. Secondary objectives include: to evaluate subjective effects (drunkenness) after administration of alcohol and energy drinks, to assess pharmacokinetics of alcohol… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol-Related Disorders, Drinking and Driving
- What is being tested?
- Alcohol and energy drink, Alcohol and Energy drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesSpain
- Study dates
- Jun 2016to Sep 2016
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Understand and accept the study's procedures and sign an informed consent form
- No evidence of somatic or psychiatric disorders as per past medical history and physical examination
- EKG, blood and urine tests taken before entry into the study within the normal range. Minor and transient abnormalities may be acceptable if, according to the Principal Investigator's criterion and the state of the art, they are felt to have no clinical relevance, entail no danger to the participant, and don't interfere with the product's assessment. These abnormalities and their non-relevance must be specifically justified in writing)
- Body mass index (BMI=weight/heigth2) between 19 and 27 kg/m2, weight between 50 and 100 kg
- For premenopausal females, a regular menstrual cycle of 26-32 days duration.
- Social or recreational alcohol consumption of at least 1 unit per day (or its equivalent [7 units] over the whole week) and having experienced drunkenness several times
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- Regular consumption of beverages containing methylxanthines (at least 5 per week)
- Consumption of energy drinks several times previously
- Having a driving license
Who cannot join
- Evidence of a preexisting condition (including gastrointestinal, liver, or kidney disorders) that may alter the absorption, distribution, metabolism or excretion of the drug or symptoms suggestive of drug-induced gastrointestinal irritation
- Previous psychiatric disorders, alcoholism, abuse of prescription drugs or illegal substances or regular consumption of psychoactive drugs
- Having donated blood or having participated in this same study in the preceding 8 weeks, or having participated in any clinical trial with drugs in the preceding 12 weeks
- Having had any somatic disease or having undergone major surgery in the 3 months prior to inclusion in the trial
- Individuals intolerant or having experienced a severe adverse reaction to alcohol or energy drinks
- Having regularly taken medication in the month before the trial, except for vitamins, herb-based remedies, dietary supplements that if, according to the Principal Investigator or his appointed collaborators' opinion, they pose no threat to the subjects and they won't interfere with the study's objectives. Single doses of symptomatic drugs taken during the week before the experimental session will not constitute an exclusion criterion if it can be assumed that it has been completely eliminated on the day of the experimental session
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- Smokers of >5 cigarettes/day
- Consumption of >20 g/day of alcohol (females) or of >40 g/day (males)
- Daily consumption of more than 5 coffees, teas, cola drinks or other stimulant or xanthine-containing beverages in the 3 months prior to inclusion in the study
- Hepatitis B, hepatitis C or human immunodeficiency virus-positive individuals
- Pregnant or lactating women, or those using hormonal or unreliable contraceptive methods during the study period. Complete abstinence, intrauterine devices, double barrier methods or a vasectomized sexual partner will be considered acceptable
- Women with amenorrhea or suffering severe premenstrual syndrome
- Individuals of Asian ascent
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
IMIM
Barcelona, Barcelona, 08003
Parc de Salut Mar-IMIM
Barcelona, Barcelona, 08003
About this study
Official title: Effects of Alcohol and Energy Drinks on Driving Performance and Bleeding Risk
The main objective of the project is to assess whether there is an interaction between the effects of ethanol and energy drinks on driving performance.
Secondary objectives include: to evaluate subjective effects (drunkenness) after administration of alcohol and energy drinks, to assess pharmacokinetics of alcohol, caffeine and taurine after alcohol and energy drinks administration and to assess if there is an increased risk of bleeding when both drinks are taken together.
Read the detailed description
Consumption of energy drinks improve psychomotor performance and alertness. These drinks contain mostly caffeine, taurine and vitamins. Its consumption associated with ethanol may reduce feelings of drunkenness as the stimulant effects of caffeine could counteract the depressing effects of ethanol on the central nervous system. Reducing the perception of intoxication may predispose the intoxicated person to engage in risky behaviors such as driving under the influence of ethanol and therefore can increase the risk of a traffic accident. Furthermore, the combination of both beverages may increase the risk of bleeding in case of injury as anticoagulant effects have been described for ethanol while antiplatelet effects have been described for caffeine and taurine. A randomized clinical trial will be performed in healthy volunteers administering 4 treatment conditions: alcohol+energy drink, alcohol+placebo of energy drink, placebo of alcohol+energy drink and placebo of alcohol+placebo of energy drink. A multiple dose will be administered separated by 1 hour.
- Conditions
- Alcohol-Related Disorders, Drinking and Driving
- Being tested
- Alcohol and energy drink, Alcohol, Energy drink, Placebo
- Keywords
- alcohol, energy drink, coagulability, caffeine, taurine, driving performance
- Medical subject headings
- Alcohol-Related Disorders, Driving Under the Influence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol and energy drinkDietary supplement
Multiple oral dose of alcohol Multiple oral dose of energy drink
AlcoholDietary supplement
Multiple oral dose of alcohol
Energy drinkDietary supplement
Multiple oral dose of energy drink
PlaceboDietary supplement
Also called Non-active treatment
Multiple oral dose of water Multiple oral dose of non-caffeinated soft drink
| Study group | Role | What they receive |
|---|---|---|
| Alcohol and energy drink | Experimental | Alcohol 60 g, multiple dose (30 g+30 g), oral administration. 3 energy drinks (750 ml), multiple dose (375 ml+375 ml), oral administration. Receives: Dietary Supplement: Alcohol and energy drink |
| Alcohol | Active comparator | Alcohol 60 g, multiple dose (30 g+30 g), oral administration. 3 non-caffeinated soft drinks (750 ml), multiple dose (375 ml+375 ml), oral administration. Receives: Dietary Supplement: Alcohol |
| Energy drink | Active comparator | 3 energy drinks (750 ml), multiple dose (375 ml+ 375 ml), oral administration. Font Vella water (188ml), multiple dose (94 ml+ 94 ml), oral administration. Receives: Dietary Supplement: Energy drink |
| Placebo | Placebo comparator | 3 non-caffeinated soft drinks (750 ml), multiple dose (375 ml+375 ml), oral administration.
Font Vella water (188ml), multiple dose (94 ml+ 94 ml), oral administration. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tracking test performance
The total time outside the road will be measured in the tracking test
Measured: From baseline till 4 hours after administration
Secondary outcomes (30)
Change in simple reaction time (SRT)
Test will be performed using the computerized cognitive testing battery CANTAB and mean latency will be measured
Measured: From baseline till 4 hours after administration
Change in movement estimation
The lapse of time between actual and predicted time will be measured in a movement estimation task
Measured: From baseline till 4 hours after administration
Change in memory function
The N-Back test will be performed with 2 different options: 0 back test and 2 back test
Measured: From baseline till 4 hours after administration
Change in drunkenness
Drunkenness will be measured using a visual analog scale (0-100 mm)
Measured: From baseline till 8 hours after administration
Change in drowsiness
Drowsiness will be measured using a visual analog scale (0-100 mm)
Measured: From baseline till 8 hours after administration
Change in headache
Headache will be measured using a visual analog scale (0-100 mm)
Measured: From baseline till 8 hours after administration
Change in palpitations
Palpitations will be measured using a visual analog scale (0-100 mm)
Measured: From baseline till 8 hours after administration
Change in anxiety
Anxiety will be measured using a visual analog scale (0-100 mm)
Measured: From baseline till 8 hours after administration
Change in subjective effects measured with Addiction Research Center Inventory (ARCI)
Subjective effects of alcohol and caffeine will be measured using Addiction Research Center Inventory
Measured: From baseline till 8 hours after administration
Change in subjective effects measured with Biphasic alcohol effects scale (BAES)
Subjective effects of alcohol will be measured using BAES
Measured: From baseline till 8 hours after administration
Change in blood pressure
Systolic and diastolic blood pressure will be measured
Measured: From baseline till 8 hours after administration
Change in heart rate
Heart rate will be measured
Measured: From baseline till 8 hours after administration
Change in oral temperature
Oral temperature will be measured
Measured: From baseline till 8 hours after administration
Number of participants with serious and non-serious adverse events
Collection of adverse effects spontaneously reported by the participants and/or observed by the investigators
Measured: From inclusion till one week after the last experimental session
Area under the concentration-time curve (AUC 0-8h) of ethanol blood concentrations
Calculation of AUC of ethanol concentrations obtained baseline and 0.25, 0.50h , 0.75, 1, 1.50, 1.75, 2, 2.25, 2.5, 3, 4, 6 and 8h after administration
Measured: From baseline till 8 hours after administration
Area under the concentration-time curve (AUC 0-8h) of taurine blood concentrations
Calculation of AUC of ethanol concentrations obtained baseline and 0.50,1, 1.50, 2, 4, 6 and 8h after administration
Measured: From baseline till 8 hours after administration
Area under the concentration-time curve (AUC 0-8h) of caffeine blood concentrations
Calculation of AUC of ethanol concentrations obtained baseline and 0,25, 0.50,1, 1.50, 2, 3, 4, 6 and 8h after administration
Measured: From baseline till 8 hours after administration
Area under the concentration-time curve (AUC 0-8h) of ethanol breath air concentrations
Calculation of AUC of ethanol concentrations obtained baseline and 0.25, 0.50, 0.75,1, 1.50, 1.75, 2, 2.25, 2.5, 3, 4, 6 and 8h after administration
Measured: From baseline till 8 hours after administration
Maximum concentration (Cmax) of taurine
Measured: From baseline till 8 hours after administration
Maximum concentration (Cmax) of ethanol
Measured: From baseline till 8 hours after administration
Maximum concentration (Cmax) of caffeine
Measured: From baseline till 8 hours after administration
Time to reach maximum concentration (tmax) of ethanol
Measured: From baseline till 8 hours after administration
Time to reach maximum concentration (tmax) of caffeine
Measured: From baseline till 8 hours after administration
Time to reach maximum concentration (tmax) of taurine
Measured: From baseline till 8 hours after administration
Blood coagulation prothrombin
Prothrombin time (PT) and ratio will be measured
Measured: From baseline till 2 hours after administration
Blood coagulation thromboplastin
Activated partial thromboplastin time (APTT) and ratio will be measured
Measured: From baseline till 2 hours after administration
Platelet aggregation (function)
Platelet function (PFA) will be measured
Measured: From baseline till 2 hours after administration
Platelet count
Platelet count will be measured
Measured: From baseline till 2 hours after administration
Change in willingness to drive
Willingness to drive in 3 different situations will be measured by means of a visual analog scale
Measured: From baseline till 6 hours after administration
Like the drug (drink)
Drug liking will be measured using a visual analog scale (0-100 mm)
Measured: At the end of each experimental session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2016
- Study completionSep 2016
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 Alcohol-Related DisordersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clara Pérez, Parc de Salut Mar
- Investigators
- Clara Pérez Mañá, PhD, MD, Principal investigator, IMIM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771587
- Sponsor's protocol ID
- IMIMFTCL/AEDED
- Acronym
- AEDED
- Status last verified
- Oct 2016
- First submitted
- 10 May 2016
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Perez-Mana C, Mateus JA, Diaz-Pellicer P, Diaz-Baggerman A, Perez M, Pujadas M, Fonseca F, Papaseit E, Pujol J, Langohr K, de la Torre R. Effects of Mixing Energy Drinks With Alcohol on Driving-Related Skills. Int J Neuropsychopharmacol. 2022 Jan 12;25(1):13-25. doi: 10.1093/ijnp/pyab051.
PubMed 34338762
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Alcohol and Energy Drinks on Driving Performance and Bleeding Risk
- ClinicalTrials.gov ID
- NCT02771587
- Acronym / sponsor ID
- AEDED / IMIMFTCL/AEDED
- Conditions
- Alcohol-Related Disorders, Drinking and Driving
- Keywords
- alcohol, energy drink, coagulability, caffeine, taurine, driving performance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 13 May 2016 (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 main objective of the project is to assess whether there is an interaction between the effects of ethanol and energy drinks on driving performance.
Secondary objectives include: to evaluate subjective effects (drunkenness) after administration of alcohol and energy drinks, to assess pharmacokinetics of alcohol, caffeine and taurine after alcohol and energy drinks administration and to assess if there is an increased risk of bleeding when both drinks are taken together.
Detailed description
Consumption of energy drinks improve psychomotor performance and alertness. These drinks contain mostly caffeine, taurine and vitamins. Its consumption associated with ethanol may reduce feelings of drunkenness as the stimulant effects of caffeine could counteract the depressing effects of ethanol on the central nervous system. Reducing the perception of intoxication may predispose the intoxicated person to engage in risky behaviors such as driving under the influence of ethanol and therefore can increase the risk of a traffic accident. Furthermore, the combination of both beverages may increase the risk of bleeding in case of injury as anticoagulant effects have been described for ethanol while antiplatelet effects have been described for caffeine and taurine. A randomized clinical trial will be performed in healthy volunteers administering 4 treatment conditions: alcohol+energy drink, alcohol+placebo of energy drink, placebo of alcohol+energy drink and placebo of alcohol+placebo of energy drink. A multiple dose will be administered separated by 1 hour.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alcohol and energy drink | Experimental | Dietary Supplement: Alcohol and energy drinkAlcohol 60 g, multiple dose (30 g+30 g), oral administration. 3 energy drinks (750 ml), multiple dose (375 ml+375 ml), oral administration. |
| Alcohol | Active comparator | Dietary Supplement: AlcoholAlcohol 60 g, multiple dose (30 g+30 g), oral administration. 3 non-caffeinated soft drinks (750 ml), multiple dose (375 ml+375 ml), oral administration. |
| Energy drink | Active comparator | Dietary Supplement: Energy drink3 energy drinks (750 ml), multiple dose (375 ml+ 375 ml), oral administration. Font Vella water (188ml), multiple dose (94 ml+ 94 ml), oral administration. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo3 non-caffeinated soft drinks (750 ml), multiple dose (375 ml+375 ml), oral administration. Font Vella water (188ml), multiple dose (94 ml+ 94 ml), oral administration. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Understand and accept the study's procedures and sign an informed consent form
- No evidence of somatic or psychiatric disorders as per past medical history and physical examination
- EKG, blood and urine tests taken before entry into the study within the normal range. Minor and transient abnormalities may be acceptable if, according to the Principal Investigator's criterion and the state of the art, they are felt to have no clinical relevance, entail no danger to the participant, and don't interfere with the product's assessment. These abnormalities and their non-relevance must be specifically justified in writing)
- Body mass index (BMI=weight/heigth2) between 19 and 27 kg/m2, weight between 50 and 100 kg
- For premenopausal females, a regular menstrual cycle of 26-32 days duration.
Key exclusion criteria (13 listed)
- Evidence of a preexisting condition (including gastrointestinal, liver, or kidney disorders) that may alter the absorption, distribution, metabolism or excretion of the drug or symptoms suggestive of drug-induced gastrointestinal irritation
- Previous psychiatric disorders, alcoholism, abuse of prescription drugs or illegal substances or regular consumption of psychoactive drugs
- Having donated blood or having participated in this same study in the preceding 8 weeks, or having participated in any clinical trial with drugs in the preceding 12 weeks
- Having had any somatic disease or having undergone major surgery in the 3 months prior to inclusion in the trial
- Individuals intolerant or having experienced a severe adverse reaction to alcohol or energy drinks
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 |
|---|---|---|
| Alcohol and energy drinkMultiple oral dose of alcohol Multiple oral dose of energy drink | Dietary supplement | Alcohol and energy drink |
| AlcoholMultiple oral dose of alcohol | Dietary supplement | Alcohol |
| Energy drinkMultiple oral dose of energy drink | Dietary supplement | Energy drink |
| PlaceboAlso: Non-active treatmentMultiple oral dose of water Multiple oral dose of non-caffeinated soft drink | Dietary supplement | Placebo |
Primary outcome
Change in tracking test performance
Time frame: From baseline till 4 hours after administration
The total time outside the road will be measured in the tracking test
30 secondary outcomes
Change in simple reaction time (SRT)
Time frame: From baseline till 4 hours after administration
Change in movement estimation
Time frame: From baseline till 4 hours after administration
Change in memory function
Time frame: From baseline till 4 hours after administration
Change in drunkenness
Time frame: From baseline till 8 hours after administration
Change in drowsiness
Time frame: From baseline till 8 hours after administration
Change in headache
Time frame: From baseline till 8 hours after administration
Change in palpitations
Time frame: From baseline till 8 hours after administration
Change in anxiety
Time frame: From baseline till 8 hours after administration
Change in subjective effects measured with Addiction Research Center Inventory (ARCI)
Time frame: From baseline till 8 hours after administration
Change in subjective effects measured with Biphasic alcohol effects scale (BAES)
Time frame: From baseline till 8 hours after administration
Change in blood pressure
Time frame: From baseline till 8 hours after administration
Change in heart rate
Time frame: From baseline till 8 hours after administration
Change in oral temperature
Time frame: From baseline till 8 hours after administration
Number of participants with serious and non-serious adverse events
Time frame: From inclusion till one week after the last experimental session
Area under the concentration-time curve (AUC 0-8h) of ethanol blood concentrations
Time frame: From baseline till 8 hours after administration
Area under the concentration-time curve (AUC 0-8h) of taurine blood concentrations
Time frame: From baseline till 8 hours after administration
Area under the concentration-time curve (AUC 0-8h) of caffeine blood concentrations
Time frame: From baseline till 8 hours after administration
Area under the concentration-time curve (AUC 0-8h) of ethanol breath air concentrations
Time frame: From baseline till 8 hours after administration
Maximum concentration (Cmax) of taurine
Time frame: From baseline till 8 hours after administration
Maximum concentration (Cmax) of ethanol
Time frame: From baseline till 8 hours after administration
Maximum concentration (Cmax) of caffeine
Time frame: From baseline till 8 hours after administration
Time to reach maximum concentration (tmax) of ethanol
Time frame: From baseline till 8 hours after administration
Time to reach maximum concentration (tmax) of caffeine
Time frame: From baseline till 8 hours after administration
Time to reach maximum concentration (tmax) of taurine
Time frame: From baseline till 8 hours after administration
Blood coagulation prothrombin
Time frame: From baseline till 2 hours after administration
Blood coagulation thromboplastin
Time frame: From baseline till 2 hours after administration
Platelet aggregation (function)
Time frame: From baseline till 2 hours after administration
Platelet count
Time frame: From baseline till 2 hours after administration
Change in willingness to drive
Time frame: From baseline till 6 hours after administration
Like the drug (drink)
Time frame: At the end of each experimental session
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 19 Oct 2016.
- Derived from this study: PubMed 34338762Perez-Mana C, Mateus JA, Diaz-Pellicer P, Diaz-Baggerman A, Perez M, Pujadas M, Fonseca F, Papaseit E, Pujol J, Langohr K, de la Torre R. Effects of Mixing Energy Drinks With Alcohol on Driving-Related Skills. Int J Neuropsychopharmacol. 2022 Jan 12;25(1):13-25. doi: 10.1093/ijnp/pyab051.
- Individual participant dataSharing planned: No
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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.
Clara Pérez Mañá, PhD, MD principal investigator
IMIM
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alcohol and energy drink, Alcohol and Energy drink in people with Alcohol-Related Disorders and Drinking and Driving, run by Parc de Salut Mar at 2 sites in Spain.
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 9 inclusion and 13 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 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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 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 in tracking test performance (time frame: From baseline till 4 hours after administration). 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 NCT02771587, 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 19 Oct 2016.