HealthyPhase 1NCT02037165

Effectiveness of Two Different Doses of BI 1026706 on the Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of Laser (Somatosensory, Radiant-heat) Evoked Potentials (LEP) in UVB(Ultraviolet)-Irradiated Skin in Healthy Male Volunteers

A Phase 1 study testing Pregabalin, BI 1026706 and Celecoxib in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To investigate the influence of different doses of BI 1026706 on the primary endpoint (PtP-amplitude LEP in UV skin) compared to placebo. The comparison of both doses of BI 1026706 to celecoxib in the UVB treatment. Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Pregabalin, BI 1026706 and Celecoxib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 25 participants
Where: 1 siteGermany
Study dates: 21 Jan 2014to 15 Apr 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead electrocardiogram, and clinical laboratory
Age 18 to 55 years (incl.)
BMI (Body Mass Index) 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Who cannot join

Any finding in the medical examination (including Blood Pressure, Pulse Rate or Electrocardiogram) deviating from normal and judged clinically relevant by the investigator
Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)
Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

Trial locations and contacts

1 site in 1 country.

Germany1 site

1320.3.1 Boehringer Ingelheim Investigational Site
Dornach

Other trials in Germany

About this study

Official title: Effectiveness of Two Different Doses of BI 1026706 on the Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of Laser (Somatosensory, Radiant-heat) Evoked Potentials (LEP) in UVB (Ultraviolet)-Irradiated Skin in Healthy Male Volunteers (a Single-blinded, Randomised, Placebo-controlled, Single-dose, Five-way Crossover Study)

To investigate the influence of different doses of BI 1026706 on the primary endpoint (PtP-amplitude LEP in UV skin) compared to placebo.
The comparison of both doses of BI 1026706 to celecoxib in the UVB treatment.
Comparison of both doses of BI 1026706 to placebo and pregabalin in the capsaicin treatment
Exploration of the pharmacokinetics of BI 1026706
Exploration of safety and tolerability of BI 1026706

Conditions: Healthy
Being tested: Placebo to BI 1026706, Pregabalin, BI 1026706, Celecoxib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo to BI 1026706Drug
Placebo tablet
PregabalinDrug
Pregabalin hard capsule
BI 1026706Drug
BI 1026706 oral solution
CelecoxibDrug
Celecoxib hard capsule

Study groups in NCT02037165
Study group	Role	What they receive
Test Treatment 1: BI 1026706	Experimental	BI 1026706 plus matching placebo to BI 1026706 Powder for Oral Solution (PfOS) and placebo tablet Receives: Drug: Placebo to BI 1026706; Drug: BI 1026706
Test Treatment 2: BI 1026706	Experimental	BI 1026706 and placebo tablet Receives: Drug: Placebo to BI 1026706; Drug: BI 1026706
Reference Treatment 1: BI 1026706	Experimental	Matching placebo to BI 1026706 PfOS and placebo tablet Receives: Drug: Placebo to BI 1026706
Reference Treatment 2: Celecoxib	Experimental	Celecoxib hard capsule as active comparator plus matching placebo to BI 1026706 PfOS Receives: Drug: Placebo to BI 1026706; Drug: Celecoxib
Reference Treatment 3: Pregabalin	Experimental	Pregabalin hard capsule as active comparator plus matching placebo to BI 1026706 PfOS Receives: Drug: Placebo to BI 1026706; Drug: Pregabalin

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin
Overall Peak-to-Peak (PtP) N2/P2-component amplitude of Laser (somatosensory/radiant heat) evoked potentials (LEP) in UVB-irradiated skin.
Treated set (TS)
Measured: up to 24 hours (h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])

Secondary outcomes (8)

Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin
Overall Peak-to-Peak (PtP) N2/P2-component amplitude of (LEP) in capsaicin-irritated skin.
Measured: up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
Single "Peripheral" N2-component Amplitudes - Measured in UVB-irradiated Skin Type
Single "peripheral" N2-component amplitudes - measured in UVB-irradiated skin type.
Measured: up to 24 hours(h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
Single "Peripheral" N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
Single "peripheral" N2-component amplitudes - measured in capsaicin-irritated skin type.
Measured: up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
Single "Central" P2-component Amplitudes - Measured in UVB-irradiated Skin Type
Single "central" P2-component amplitudes - measured in UVB-irradiated skin type.
Measured: up to 24 hours(h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
Single "Central" P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
Single "central" P2-component amplitudes - measured in capsaicin-irritated skin type.
Measured: up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
Electronic Visual Analogue Scale (VAS) (100mm VAS "Post Laser Pain" Scales) - Measured in the UVB-irradiated Skin Type
Electronic Visual Analogue Scale (100mm VAS "Post Laser Pain" scales) - measured in the UVB-irradiated skin type, where 0mm = 'no pain' and 100mm = 'severe pain'.
Measured: up to 24 hours(h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
Electronic Visual Analogue Scale (100mm VAS "Post Laser Pain" Scales) - Measured in the Capsaicin-irritated Skin Type.
Electronic Visual Analogue Scale (100mm VAS "Post Laser Pain" scales) - measured in the capsaicin-irritated skin type, where 0mm = 'no pain' and 100mm = 'severe pain'.
Measured: up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin
Weighted needle (pain) threshold (WNT) in the secondary flare area of capsaicin-irritated skin. The weighted needle (pain) threshold (WNT) will be determined (with regard to investigation of mechanical hyperalgesia in the secondary hyperalgesia zone around the primary capsaicin application zone) by fixed weight steps - contact made by "rounded" needle tip to skin (ranging from 1 mN to 512 mN).
Measured: up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jan 201415 Apr 2014

First posted15 Jan 2014 (estimated)
Study start21 Jan 2014
Primary completion9 Apr 2014
Study completion15 Apr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02037165
Sponsor's protocol ID: 1320.3
Other IDs: 2012-005691-33
Status last verified: Apr 2019
First submitted: 14 Jan 2014
Last updated: 5 Jul 2019
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Two Different Doses of BI 1026706 on the Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of Laser (Somatosensory, Radiant-heat) Evoked Potentials (LEP) in UVB (Ultraviolet)-Irradiated Skin in Healthy Male Volunteers (a Single-blinded, Randomised, Placebo-controlled, Single-dose, Five-way Crossover Study)
ClinicalTrials.gov ID: NCT02037165
Acronym / sponsor ID: 1320.3
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 21 Jan 2014 (actual)
Primary completion: 9 Apr 2014 (actual)
Study completion: 15 Apr 2014 (actual)
First posted: 15 Jan 2014 (estimated)
Results: Posted 5 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To investigate the influence of different doses of BI 1026706 on the primary endpoint (PtP-amplitude LEP in UV skin) compared to placebo.
The comparison of both doses of BI 1026706 to celecoxib in the UVB treatment.
Comparison of both doses of BI 1026706 to placebo and pregabalin in the capsaicin treatment
Exploration of the pharmacokinetics of BI 1026706
Exploration of safety and tolerability of BI 1026706

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Number of arms: 5

Arm	Type	Receives
Test Treatment 1: BI 1026706	Experimental	Drug: Placebo to BI 1026706, Drug: BI 1026706BI 1026706 plus matching placebo to BI 1026706 Powder for Oral Solution (PfOS) and placebo tablet
Test Treatment 2: BI 1026706	Experimental	Drug: Placebo to BI 1026706, Drug: BI 1026706BI 1026706 and placebo tablet
Reference Treatment 1: BI 1026706	Experimental	Drug: Placebo to BI 1026706Matching placebo to BI 1026706 PfOS and placebo tablet
Reference Treatment 2: Celecoxib	Experimental	Drug: Placebo to BI 1026706, Drug: CelecoxibCelecoxib hard capsule as active comparator plus matching placebo to BI 1026706 PfOS
Reference Treatment 3: Pregabalin	Experimental	Drug: Placebo to BI 1026706, Drug: PregabalinPregabalin hard capsule as active comparator plus matching placebo to BI 1026706 PfOS

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead electrocardiogram, and clinical laboratory
Age 18 to 55 years (incl.)
BMI (Body Mass Index) 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Key exclusion criteria (7 listed)

Any finding in the medical examination (including Blood Pressure, Pulse Rate or Electrocardiogram) deviating from normal and judged clinically relevant by the investigator
Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

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
Placebo to BI 1026706Placebo tablet	Drug	Reference Treatment 1: BI 1026706, Reference Treatment 2: Celecoxib, Reference Treatment 3: Pregabalin, Test Treatment 1: BI 1026706, Test Treatment 2: BI 1026706
PregabalinPregabalin hard capsule	Drug	Reference Treatment 3: Pregabalin
BI 1026706BI 1026706 oral solution	Drug	Test Treatment 1: BI 1026706, Test Treatment 2: BI 1026706
CelecoxibCelecoxib hard capsule	Drug	Reference Treatment 2: Celecoxib

Primary outcome

Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin
Time frame: up to 24 hours (h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
Overall Peak-to-Peak (PtP) N2/P2-component amplitude of Laser (somatosensory/radiant heat) evoked potentials (LEP) in UVB-irradiated skin. Treated set (TS)

8 secondary outcomes

Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin
Time frame: up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
Single "Peripheral" N2-component Amplitudes - Measured in UVB-irradiated Skin Type
Time frame: up to 24 hours(h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
Single "Peripheral" N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
Time frame: up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
Single "Central" P2-component Amplitudes - Measured in UVB-irradiated Skin Type
Time frame: up to 24 hours(h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
Single "Central" P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
Time frame: up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
Electronic Visual Analogue Scale (VAS) (100mm VAS "Post Laser Pain" Scales) - Measured in the UVB-irradiated Skin Type
Time frame: up to 24 hours(h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
Electronic Visual Analogue Scale (100mm VAS "Post Laser Pain" Scales) - Measured in the Capsaicin-irritated Skin Type.
Time frame: up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin
Time frame: up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])

Results and safety

Results posted to the registry on 5 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
50mg BI1026706/200mg BI1026706/Placebo/200mg Cele/150mg Preg	5	5
200mg BI1026706/50mg BI1026706/200mg Cele/150mg Preg/Placebo	5	5
Placebo/150mg Preg/50mg BI1026706/200mg BI1026706/200mg Cele	5	5
200mg Cele/Placebo/150mg Preg/50mg BI1026706/200mg BI1026706	5	5
150mg Preg/200mg Cele/200mg BI1026706/Placebo/50mg BI1026706	5	5

Primary outcome: Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin

Time frame: up to 24 hours (h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min]). Mean (Standard Deviation). Unit: Microvolts (µv)

Measure	Placebo n = 25	50 mg BI 1026706 n = 24	200 mg BI 1026706 n = 25	200 mg Celecoxib (Cele) n = 25
at -2:05h	29.22 (8.98)	26.08 (10.41)	28.93 (8.06)	26.35 (9.22)
at 0:30h	27.84 (8.83)	28.00 (10.67)	24.88 (8.69)	26.60 (8.90)
at 1:00h	25.57 (10.02)	27.11 (8.64)	26.77 (10.31)	27.60 (9.31)
at 2:00h	26.74 (8.51)	28.78 (8.81)	29.03 (9.04)	24.87 (7.11)
at 3:00h	29.48 (9.50)	30.93 (7.39)	29.02 (7.98)	25.05 (8.32)
at 4:00h	30.54 (8.77)	31.40 (10.90)	31.44 (8.42)	23.97 (7.71)
at 5:00h	31.74 (10.07)	30.10 (8.37)	30.79 (9.84)	24.10 (8.78)
at 6:00h	32.16 (10.48)	28.12 (8.29)	29.04 (10.66)	26.77 (8.61)

Placebo vs 50 mg BI 1026706: adjusted mean difference: 1.12 (95% CI -3.0 to 5.2)
Placebo vs 50 mg BI 1026706: adjusted mean difference: 2.66 (95% CI -1.4 to 6.8)
Placebo vs 50 mg BI 1026706: adjusted mean difference: 3.00 (95% CI -1.1 to 7.1)

Population analysed: pharmacodynamic set(PDS): included all subjects from the TS who provided in any treatment period a baseline value and at least 1 PD profile post drug administration for the primary or secondary PD endpoint, which was considered evaluable, and without (important) protocol violation(s) with respect to the statistical evaluation of PD endpoints.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the start day of trial medication administration to Day 3 ( 3 days after the last trial medication). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 25 (0%)	3 of 25 (12%)	Not reported
50 mg BI 1026706	0 of 24 (0%)	2 of 24 (8.3%)	Not reported
200 mg BI 1026706	0 of 25 (0%)	3 of 25 (12%)	Not reported
200 mg Celecoxib	0 of 25 (0%)	2 of 25 (8%)	Not reported
150 mg Pregabalin	0 of 25 (0%)	17 of 25 (68%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

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 Pregabalin, BI 1026706 and Celecoxib in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

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 4 inclusion and 7 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 5 Jul 2019. 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 Germany. 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?

Yes. Results are posted in the registry (first posted 5 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin (time frame: up to 24 hours (h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])). 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 NCT02037165.

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 5 Jul 2019; AzTrials last refreshed its copy on 7 Nov 2026.