Healthy Male AdultsPhase 1NCT01983514

Effects of Intranasal Administration of a Single Dose of Oxytocin Using a Novel Device in Healthy Adults

A Phase 1 study testing 8IU intranasal oxytocin, 24 IU intranasal oxytocin and 1 IU intravenous oxytocin in people with Healthy Male Adults, run by OptiNose AS at 1 site in Norway.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Male Adults
What is being tested?: 8IU intranasal oxytocin, 24 IU intranasal oxytocin and 1 IU intravenous oxytocin
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 19 participants
Where: 1 siteNorway
Study dates: Oct 2013to Feb 2014
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 35 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy, male subjects aged 18 to 35 years inclusive.
Subjects must be in good general health, as determined by the investigator.
Subject's pre-study physical examination, vital signs and electrocardiogram (ECG) are normal or do not show any clinically significant abnormalities as determined by the investigator. Vital signs must not have any clinically significant deviations outside of the following ranges when measured sitting after 5 minutes rest:
Heart rate: 40 to 90 beats per minute
Systolic blood pressure (BP): 90 to 140 mmHg
Diastolic BP: 50 to 90 mmHg

Show all 11Show fewer

Oral temperature: 36.0 to 37.5°C
Respiratory rate: 12 - 18 breaths per minute
Body Mass Index (BMI) of 18.5 - 29.9 kg/m2 (both inclusive)
Subjects must be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent
Provision of written informed consent.

Who cannot join

An ear, nose and throat (ENT) specialist will inspect the noses of all individuals who enter the study.
In order to participate in the study subjects must not meet any of the following exclusion criteria;
Individuals showing major septal deviation or a significantly altered nasal epithelium.
Participants with evidence of previous nasal disease, surgery, and dependence on inhaled drugs.
Individuals with current significant nasal congestion due to common colds.
Subjects with a clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, psychiatric, gastrointestinal, pulmonary, haematological or metabolic disorder.

Show all 20Show fewer

Subjects with current or history of, any clinically significant disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
Subject is taking any regular prescribed or over-the-counter (OTC) medications including vitamin supplements and herbal remedies. There must be at least 14 days between stopping these products and the first dose of study medication).
Systemic illness requiring treatment within 2 weeks prior to Study Day 1.
History of significant drug or alcohol abuse (as per a self-report measure / instrument; World Health Organisation criteria/Alcohol use disorders identification test/Drug use disorders identification test). Subjects with a positive screen for alcohol or drugs of abuse at screening/admission will be excluded from participation in the study.
Self-reported significant psychiatric conditions.
Any abnormal laboratory values outside normal range, and which is clinically significant as deemed by investigator.
Full scale intelligence quotient (IQ) < 75 (due to the prerequisite ability to complete self report measures).
Known allergic reactions or hypersensitivity to any component of the study medication in the nasal spray, such as E216, E218 and chlorobutanol hemihydrate.
Participation in any (other) clinical trial with an investigational medicinal product or medical device within 3 months prior to randomisation.
Current evidence of any mental or physical disorder or collaboration attitude which, in the judgment of the investigator makes the subject unsuitable for enrolment, and/or may interfere with the study evaluations or affect subject's safety.
Subjects with any metal implants.
Subjects with claustrophobia.
Other unspecified reasons that, in the opinion of the Investigator or the sponsor make the subject unsuitable for enrolment.
Subjects with female partners of child-bearing potential must use an adequate form of contraception prior to entry into the study until three months following the post-study medical visit. Subjects must not have a partner who is either pregnant or breastfeeding for the duration of the study. Adequate contraception is defined as the usage by the female partner of any form of hormonal contraception or intra-uterine device (which should be established prior to the start of the study) plus usage by one of the partners of an additional spermicide- containing barrier method of contraception.

Trial locations and contacts

1 site in 1 country.

Norway1 site

Norwegian Centre for Mental Disorders Research (NORMENT), KG Jebsen Centre for Psychosis Research - TOP Study
Oslo

Other trials in Norway

About this study

Official title: Intranasal (Optinose Bidirectional Nose-to-brain Device) Versus Intravenous Slow Infusion of Oxytocin - a Randomized, Placebo- Controlled Double-blind, Double-dummy 4-period Cross-over Study in Healthy Adult Volunteers Evaluating Brain Functional Magnetic Resonance Imaging Changes, Cognitive Response, Heart Rate Variability, Plasma Pharmacokinetics and Saliva Concentration After Single-dose Oxytocin 8 or 24 International Units (IU) Intranasally or 1 IU as Slow Intravenous Infusion

Oxytocin (OT) is a small, naturally occurring peptide currently in clinical use to stimulate lactation in breastfeeding women. The intranasal administration of OT has recently attracted attention as a potential novel treatment in several psychiatric disorders including autism. However, given the anatomy of the nasal cavity, the current design of nasal sprays would be expected to provide an inadequate delivery of medication to the areas of the nasal cavity where direct transport into the brain via the olfactory nerve could potentially occur. OptiNose has developed an intranasal delivery device that provides improved reproducibility of nasal delivery, improved deposition to the upper posterior regions of the nasal cavity where the olfactory nerve innervates the nasal cavity.

The primary objective of this study is to identify any differences between single dose 8 or 24 international units (IU) oxytocin delivered intranasally with the optimised OptiNose device and 1 IU oxytocin administered as slow intravenous infusion in healthy volunteers. This will be measured in terms of brain activity as measured with functional magnetic resonance imaging (fMRI), performance on cognitive tests, and physiological markers.

Conditions: Healthy Male Adults
Being tested: 8IU intranasal oxytocin, 24 IU intranasal oxytocin, 1 IU intravenous oxytocin, Placebo
Keywords: oxytocin, fMRI, social cognition, heart rate variability, pupillometry, eye tracking

What participants receive

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

8IU intranasal oxytocinDrug
24 IU intranasal oxytocinDrug
1 IU intravenous oxytocinDrug
PlaceboDrug

Study groups in NCT01983514
Study group	Role	What they receive
1 international unit (IU) intravenous oxytocin	Active comparator	Using a double-dummy design participants will be administered 1 IU oxytocin (mixed in 200 ml 0.9% sodium chloride) slow infusion with varying infusion rate over 20 minutes and placebo delivered with the OptiNose Breath Powered Bi-Directional liquid device. Subject to pilot data this may be increased to 2 IU oxytocin (mixed in 200 ml 0.9% sodium chloride) and the infusion time/rate may change to best match the pharmacokinetic profile of intranasally administered oxytocin. Receives: Drug: 1 IU intravenous oxytocin
Placebo	Placebo comparator	Using a double-dummy design participants will be administered Placebo delivered with the OptiNose Breath Powered Bi-Directional liquid device and placebo delivered intravenously (0.9% sodium chloride 200 ml slow infusion for 20 minutes) Receives: Drug: Placebo
8IU intranasal oxytocin	Experimental	Using a double-dummy design participants will be administered 8IU oxytocin liquid delivered with the OptiNose Breath Powered Bi directional liquid device and IV placebo (0.9% sodium chloride, 200 ml slow infusion for 20 minutes) Receives: Drug: 8IU intranasal oxytocin
24IU intranasal oxytocin	Experimental	Using a double-dummy design participants will be administered 24IU oxytocin liquid delivered with the OptiNose Breath Powered Bi directional liquid device and IV placebo (0.9% sodium chloride, 200 ml slow infusion for 20 minutes) Receives: Drug: 24 IU intranasal oxytocin

What is being measured

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

Aim 1a: Brain activity
Scanning procedures for functional magnetic resonance imaging (fMRI) will include a functional scan during a social cognition task and structural connectivity during rest
Measured: 30 minutes after oxytocin/placebo administration
Aim 1b: Performance on a social cognition test
Participants will complete a task evaluating emotional expressions (either happy expressions, fear expressions or neutral expressions). These stimuli are identical to those published previously by Leknes et al., (2012).
Measured: 45 mins after oxytocin/placebo administration
Aim 1c: Heart rate variability
Electrocardiogram data will be collected to assess heart rate variability, a measure of cardiac autonomic function.
Measured: 20 minutes after oxytocin placebo administration
Aim 1d: Eyetracking
An eyetracking device will measure eyegaze and pupillometry.
Measured: 20 minutes after oxytocin placebo administration

Secondary outcomes (4)

Pharmacokinetic (PK) profile of oxytocin
Blood will be collected to assess levels of oxytocin present in peripheral blood to measure PK profile of 8 and 24 international units (IU) oxytocin delivered with OptiNose device and of 1 IU oxytocin after slow intravenous (IV) infusion.
Measured: 5 minutes prior to oxytocin/placebo administration
Plasma concentration of cortisol
Blood will be drawn at various intervals for the pharmacokinetic analysis of plasma cortisol.
Measured: 20 minutes before fMRI procedure
Oxytocin levels in saliva
Saliva will be collected for pharmacokinetic analysis of oxytocin and cortisol in saliva.
Measured: 20 prior to fMRI procedure
Cortisol levels in saliva
Saliva will be collected for pharmacokinetic analysis of oxytocin and cortisol in saliva.
Measured: 20 minutes prior to fMRI procedure

Timeline

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

Oct 2013Feb 2014

First posted14 Nov 2013 (estimated)
Study startOct 2013
Primary completionFeb 2014
Study completionFeb 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Healthy Male AdultsStudies 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: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01983514
Sponsor's protocol ID: SMR-2727
Status last verified: Apr 2014
First submitted: 30 Oct 2013
Last updated: 23 Apr 2014
Results posted: No
Data monitoring committee: No

Publications

Leknes S, Wessberg J, Ellingsen DM, Chelnokova O, Olausson H, Laeng B. Oxytocin enhances pupil dilation and sensitivity to 'hidden' emotional expressions. Soc Cogn Affect Neurosci. 2013 Oct;8(7):741-9. doi: 10.1093/scan/nss062. Epub 2012 May 29.
PubMed 22648957
Quintana DS, Westlye LT, Alnaes D, Rustan OG, Kaufmann T, Smerud KT, Mahmoud RA, Djupesland PG, Andreassen OA. Low dose intranasal oxytocin delivered with Breath Powered device dampens amygdala response to emotional stimuli: A peripheral effect-controlled within-subjects randomized dose-response fMRI trial. Psychoneuroendocrinology. 2016 Jul;69:180-8. doi: 10.1016/j.psyneuen.2016.04.010. Epub 2016 Apr 22.
PubMed 27107209
Quintana DS, Westlye LT, Rustan OG, Tesli N, Poppy CL, Smevik H, Tesli M, Roine M, Mahmoud RA, Smerud KT, Djupesland PG, Andreassen OA. Low-dose oxytocin delivered intranasally with Breath Powered device affects social-cognitive behavior: a randomized four-way crossover trial with nasal cavity dimension assessment. Transl Psychiatry. 2015 Jul 14;5(7):e602. doi: 10.1038/tp.2015.93.
PubMed 26171983

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?

See locations

Not yet recruitingPhase 1
A Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered Cannabidiol Capsules (AVAT-121) and Epidyolex® in Healthy Adults
Focal Onset Seizure
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
RecruitingPhase 1/2
Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Adults With and Without Androgenetic Alopecia
Androgenetic Alopecia (AGA), Healthy Volunteers - Male and Female
Recruiting
Pharmacokinetic (PK) Study of Phytochemicals in Whole Grains (WGs)- Brown Rice
Healthy Adult Males, Healthy Adult Females
RecruitingPhase 1
Study to Assess the Plasma Concentration of Rilzabrutinib Given as a Tablet to Adult Participants With Severe Renal Impairment Compared to Matched Participants With Normal Renal Function
Renal Impairment, Healthy Volunteers

All Healthy Male Adults trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intranasal (Optinose Bidirectional Nose-to-brain Device) Versus Intravenous Slow Infusion of Oxytocin - a Randomized, Placebo- Controlled Double-blind, Double-dummy 4-period Cross-over Study in Healthy Adult Volunteers Evaluating Brain Functional Magnetic Resonance Imaging Changes, Cognitive Response, Heart Rate Variability, Plasma Pharmacokinetics and Saliva Concentration After Single-dose Oxytocin 8 or 24 International Units (IU) Intranasally or 1 IU as Slow Intravenous Infusion
ClinicalTrials.gov ID: NCT01983514
Acronym / sponsor ID: SMR-2727
Conditions: Healthy Male Adults
Keywords: oxytocin, fMRI, social cognition, heart rate variability, pupillometry, eye tracking
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: OptiNose ASIndustry (pharma, biotech, devices)
Collaborators: University of Oslo
Study start: Oct 2013
Primary completion: Feb 2014 (actual)
Study completion: Feb 2014 (actual)
First posted: 14 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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
1 international unit (IU) intravenous oxytocin	Active comparator	Drug: 1 IU intravenous oxytocinUsing a double-dummy design participants will be administered 1 IU oxytocin (mixed in 200 ml 0.9% sodium chloride) slow infusion with varying infusion rate over 20 minutes and placebo delivered with the OptiNose Breath Powered Bi-Directional liquid device. Subject to pilot data this may be increased to 2 IU oxytocin (mixed in 200 ml 0.9% sodium chloride) and the infusion time/rate may change to best match the pharmacokinetic profile of intranasally administered oxytocin.
Placebo	Placebo comparator	Drug: PlaceboUsing a double-dummy design participants will be administered Placebo delivered with the OptiNose Breath Powered Bi-Directional liquid device and placebo delivered intravenously (0.9% sodium chloride 200 ml slow infusion for 20 minutes)
8IU intranasal oxytocin	Experimental	Drug: 8IU intranasal oxytocinUsing a double-dummy design participants will be administered 8IU oxytocin liquid delivered with the OptiNose Breath Powered Bi directional liquid device and IV placebo (0.9% sodium chloride, 200 ml slow infusion for 20 minutes)
24IU intranasal oxytocin	Experimental	Drug: 24 IU intranasal oxytocinUsing a double-dummy design participants will be administered 24IU oxytocin liquid delivered with the OptiNose Breath Powered Bi directional liquid device and IV placebo (0.9% sodium chloride, 200 ml slow infusion for 20 minutes)

Who may qualify

Ages: 18 to 35 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Healthy, male subjects aged 18 to 35 years inclusive.
Subjects must be in good general health, as determined by the investigator.
Subject's pre-study physical examination, vital signs and electrocardiogram (ECG) are normal or do not show any clinically significant abnormalities as determined by the investigator. Vital signs must not have any clinically significant deviations outside of the following ranges when measured sitting after 5 minutes rest:
Body Mass Index (BMI) of 18.5 - 29.9 kg/m2 (both inclusive)
Subjects must be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent

Key exclusion criteria (20 listed)

An ear, nose and throat (ENT) specialist will inspect the noses of all individuals who enter the study.
In order to participate in the study subjects must not meet any of the following exclusion criteria;
Individuals showing major septal deviation or a significantly altered nasal epithelium.
Participants with evidence of previous nasal disease, surgery, and dependence on inhaled drugs.
Individuals with current significant nasal congestion due to common colds.

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
8IU intranasal oxytocin	Drug	8IU intranasal oxytocin
24 IU intranasal oxytocin	Drug	24IU intranasal oxytocin
1 IU intravenous oxytocin	Drug	1 international unit (IU) intravenous oxytocin
Placebo	Drug	Placebo

Primary outcome

Aim 1a: Brain activity
Time frame: 30 minutes after oxytocin/placebo administration
Scanning procedures for functional magnetic resonance imaging (fMRI) will include a functional scan during a social cognition task and structural connectivity during rest
Aim 1b: Performance on a social cognition test
Time frame: 45 mins after oxytocin/placebo administration
Participants will complete a task evaluating emotional expressions (either happy expressions, fear expressions or neutral expressions). These stimuli are identical to those published previously by Leknes et al., (2012).
Aim 1c: Heart rate variability
Time frame: 20 minutes after oxytocin placebo administration
Electrocardiogram data will be collected to assess heart rate variability, a measure of cardiac autonomic function.
Aim 1d: Eyetracking
Time frame: 20 minutes after oxytocin placebo administration
An eyetracking device will measure eyegaze and pupillometry.

4 secondary outcomes

Pharmacokinetic (PK) profile of oxytocin
Time frame: 5 minutes prior to oxytocin/placebo administration
Plasma concentration of cortisol
Time frame: 20 minutes before fMRI procedure
Oxytocin levels in saliva
Time frame: 20 prior to fMRI procedure
Cortisol levels in saliva
Time frame: 20 minutes prior to fMRI procedure

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 23 Apr 2014.
Background: PubMed 22648957Leknes S, Wessberg J, Ellingsen DM, Chelnokova O, Olausson H, Laeng B. Oxytocin enhances pupil dilation and sensitivity to 'hidden' emotional expressions. Soc Cogn Affect Neurosci. 2013 Oct;8(7):741-9. doi: 10.1093/scan/nss062. Epub 2012 May 29.
Derived from this study: PubMed 27107209Quintana DS, Westlye LT, Alnaes D, Rustan OG, Kaufmann T, Smerud KT, Mahmoud RA, Djupesland PG, Andreassen OA. Low dose intranasal oxytocin delivered with Breath Powered device dampens amygdala response to emotional stimuli: A peripheral effect-controlled within-subjects randomized dose-response fMRI trial. Psychoneuroendocrinology. 2016 Jul;69:180-8. doi: 10.1016/j.psyneuen.2016.04.010. Epub 2016 Apr 22.
Derived from this study: PubMed 26171983Quintana DS, Westlye LT, Rustan OG, Tesli N, Poppy CL, Smevik H, Tesli M, Roine M, Mahmoud RA, Smerud KT, Djupesland PG, Andreassen OA. Low-dose oxytocin delivered intranasally with Breath Powered device affects social-cognitive behavior: a randomized four-way crossover trial with nasal cavity dimension assessment. Transl Psychiatry. 2015 Jul 14;5(7):e602. doi: 10.1038/tp.2015.93.
Click here for more information about NORMENT: Norwegian Centre for Mental Disorders ResearchLink provided by the sponsor.

Related trials for Healthy Male Adults

Not yet recruitingPhase 1
A Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered Cannabidiol Capsules (AVAT-121) and Epidyolex® in Healthy Adults
Focal Onset Seizure
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
RecruitingPhase 1/2
Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Adults With and Without Androgenetic Alopecia
Androgenetic Alopecia (AGA), Healthy Volunteers - Male and Female
Recruiting
Pharmacokinetic (PK) Study of Phytochemicals in Whole Grains (WGs)- Brown Rice
Healthy Adult Males, Healthy Adult Females
RecruitingPhase 1
Study to Assess the Plasma Concentration of Rilzabrutinib Given as a Tablet to Adult Participants With Severe Renal Impairment Compared to Matched Participants With Normal Renal Function
Renal Impairment, Healthy Volunteers

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.

Ole A Andreassen, MD principal investigator

University of Oslo

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 8IU intranasal oxytocin, 24 IU intranasal oxytocin and 1 IU intravenous oxytocin in people with Healthy Male Adults, run by OptiNose AS at 1 site in Norway.

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 11 inclusion and 20 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 23 Apr 2014. 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 Norway. 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?

Aim 1a: Brain activity (time frame: 30 minutes after oxytocin/placebo administration). The study lists 4 primary outcomes in all. 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 NCT01983514, which also lists 3 linked publications.

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 23 Apr 2014.