NocturiaPhase 2NCT02646826

Paxerol™ for Treatment of Nocturia - A Phase II Placebo-Controlled Trial

A Phase 2 study testing Paxerol - Dose Level 1, Paxerol - Dose Level 2 and Paxerol - Dose Level 3 in people with Nocturia, run by Wellesley Pharmaceuticals, LLC at 4 sites in United States.

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 years and older
Conditions the study is for: Nocturia
What is being tested?: Paxerol - Dose Level 1, Paxerol - Dose Level 2 and Paxerol - Dose Level 3
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 86 participants
Where: 4 sitesUnited States
Study dates: Jan 2016to Nov 2017
Phase: Phase 2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects diagnosed with nocturia, as defined by International Continence Society (i.e., the interruption of sleep one or more times at night to void), confirmed by evaluation in participating investigator's urology practice for the following characteristics: nocturia is related to overactive bladder (OAB); nightly ≥2.5 times nocturia present for at least 3 months and not considered caused by persistent or recurrent urinary tract infection; Post-Void Residual (PVR) urine volume must be <80 cc at the time of screening; did not respond well to, or unwilling to have, lifestyle modification, behavioral and conservative therapies, such as dietary changes, timed voiding, urge suppression (e.g., pelvic floor exercises [PFE] at the time of urge episodes), biofeedback, etc.
Males or females, ≥18 years of age with Body Mass Index (BMI) <40.
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation.
Ability to understand and sign the study Informed Consent Form (ICF), communicate with the investigators, and understand and comply with the requirements of the protocol, including completion of participation in all phases of the study.
No current or medical history of gastrointestinal bleeding or malformation; bleeding diathesis; or restless leg syndrome.
Not using within 4 weeks before study initiation, or anticipating the use during the study, of the following drugs: antiplatelet or anticoagulant drugs; any Selective Serotonin Re-uptake Inhibitors (SSRIs) or anti-diuretic medications; or warfarin
Resting heart rate between 55 and 100 beats per minute, inclusive of both.

Who cannot join

Pregnant or nursing women.
Known presence of urinary tract infection (UTI) within 4 weeks before study initiation
Known sleep interruptions due to sleep apnea, dyspepsia or other gastro-intestinal symptoms, seizure disorders or other neurologic symptoms
Allergy to or intolerance of acetaminophen, ibuprofen, or any inactive component of the study drug formulations.
A history of allergy to aspirin or other NSAIDs.
Congenital or acquired structural abnormality of the genitourinary tract.

Show all 24Show fewer

Prostate cancer of any stage that has required any treatment.
Any neurodegenerative disease (including but not limited to Parkinson's Disease, Alzheimer's Disease, Amyotrophic Lateral Sclerosis, Pick's Disease, Multi-Infarct Dementia or recent history of head trauma associated with concussion, stroke or serious cerebrovascular events) which may indicate problems in providing consistent and reliable Patient-Reported Outcomes (PRO) such as diary, Quality-of-Life, etc. required in this study.
Uncontrolled hypertension (blood pressure >150/100 mm Hg).
Serious medical illness, such as significant cardiac disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, or New York Heart Association Class II, III or IV), severe debilitating pulmonary disease, or history of stroke (hemorrhagic or thrombotic), A-V malformation, or other cerebrovascular disease.
Receipt of any investigational drug or participation in any clinical trial within 30 days prior to study participation.
Use of acetaminophen, ibuprofen, acetylsalicylic acid (ASA) or any NSAID on the day of entry into the study or any anticipated use during the study. In the event of the need for any unanticipated use of such drugs during the trial, the timing and doses of such use should be carefully recorded and reported at the next visit to the clinic.
Any medical problem requiring uninterrupted use of acetaminophen, ibuprofen, or any NSAIDs, or any other pain medication.
Daily use of phosphodiesterase (PDE) inhibitors (such as sildenafil, tadalafil, vardenafil, avanafil, and udenafil) within 30 days prior to study or any anticipated daily use during the study. (Note: PDE inhibitors are known to have positive effect on voiding dysfunction and thus can interfere with the assessment of Paxerol [Ückert et al 2010].)
History of polyuria or evidence of polyuria (estimation of daily production >2.5 liters of urine).
Uncontrolled Type 1 or 2 diabetes mellitus (HbA1c >7.0%).
Diabetes insipidus.
Significantly impaired renal function (creatinine clearance <50 mL/min/1.73kg/m2)
Any visual, motor or other sensory abnormality that might predispose to a fall on nocturnal arising to urinate.
Evidence of hyponatremia at baseline.
Any significant disease or abnormality of the neurological, visual, gastrointestinal, hepatobiliary, pulmonary, cardiovascular, genitourinary or musculoskeletal system other than those specified above that, in the opinion of the involved investigator, might compromise the ability of the prospective subject to participate in the study or that could confound interpretation of study results.
Any abnormality on screening medical history, physical examination or clinical laboratory examination other than those specified above that, in the opinion of the involved investigator, might confound interpretation of study results.
Subjects with known hepatitis, HIV-AIDS, or tuberculosis.
Subjects with known dysrhythmia of any form.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

A and I Medical P.C.
Brooklyn, New York, 11229
The Westchester Medical Group PC
Harrison, New York, 10604
Dr. George Klein
New York, New York, 10021
Washington High Urology
New York, New York, 10032

Other trials in United States

About this study

Official title: Paxerol™ (a Novel Formulation of Acetaminophen and Ibuprofen) for Treatment of Nocturia - A Phase II Placebo-Controlled Trial

This is a multi-center, double-blind, placebo-controlled study with two weeks of daily oral administration of one of three dose levels of Paxerol or placebo in subjects with nocturia. Eligible study subjects will be identified according to inclusion/exclusion criteria (see below), and baseline assessments will be recorded.

Due to small sample size of 25 patients per group in this proof-of-principle dosing-finding trial, stratification according to gender and BMI will be difficult. However, similar distribution of patient types to the four treatment groups will be attempted by evenly assigning patients to the four treatment groups according to genders and body mass index (BMI) of <25, 25-30 and 30-40.

Paxerol or placebo will be taken 30 minutes before bedtime daily for two weeks. Nocturia frequency, Nocturia Quality of Life (NQOL), Duration of First Undisturbed Sleep (DFUS), total hours of nightly sleep, safety and tolerability will be monitored before and after a two-week treatment period. Results from subjects treated with different doses of Paxerol and placebo will be assessed and compared. Baseline urinary Prostaglandin E2 (PGE2) production will also be assayed to assess potential correlation between baseline urinary PGE2 production and responsiveness to Paxerol treatment.

Read the detailed description

The co-primary objectives are:

To assess the effect of different doses of Paxerol on the reduction in the number of nocturia episodes.
To assess the clinical benefit of different doses of Paxerol in reducing nocturia via assessment of nocturia quality of life (NQOL).

The secondary objectives are to assess the effects of different doses of Paxerol on:

Duration of First Undisturbed Sleep (DFUS) B. Total hours of nightly sleep C. Safety and tolerability

An exploratory assessment is to evaluate baseline urinary PGE2 production on the responsiveness of subjects to Paxerol.

Study duration for each subject is approximately 4 weeks, which includes screening, baseline assessment, two weeks of treatment with study drugs, and follow-up.

Conditions: Nocturia
Being tested: Placebo, Paxerol - Dose Level 1, Paxerol - Dose Level 2, Paxerol - Dose Level 3
Medical subject headings: Nocturia

What participants receive

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

PlaceboOther
Also called Placebo control
Subjects are treated with Placebo tablets
Paxerol - Dose Level 1Drug
Also called Treatment arm 1
Subjects are treated with the first dose level of Paxerol
Paxerol - Dose Level 2Drug
Also called Treatment arm 2
Subjects are treated with the second dose level of Paxerol
Paxerol - Dose Level 3Drug
Also called Treatment arm 3
Subjects are treated with the third dose level of Paxerol

Study groups in NCT02646826
Study group	Role	What they receive
Placebo	Placebo comparator	Subjects are treated with placebo tablets. Receives: Other: Placebo
Paxerol - Dose Level 1	Experimental	Subjects are treated with the first dose level of Paxerol. Receives: Drug: Paxerol - Dose Level 1
Paxerol - Dose Level 2	Experimental	Subjects are treated with the second dose level of Paxerol. Receives: Drug: Paxerol - Dose Level 2
Paxerol - Dose Level 3	Experimental	Subjects are treated with the third dose level of Paxerol. Receives: Drug: Paxerol - Dose Level 3

What is being measured

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

Change in Nocturia Episodes
Change in number of nocturia episodes associated with one of three dose levels of Paxerol vs. placebo is assessed during the 2-week treatment period.
Measured: Up to 2 weeks
Clinical Benefit Based on Nocturia Quality of Life (NQOL).
The degree of clinical benefit, via NQOL, associated with one of three dose levels of Paxerol vs. placebo is assessed after the 2-week treatment period. This is on a scale of 0 to 100, with 0 being the best score.
Measured: Up to 2 weeks

Secondary outcomes (2)

Duration of First Undisturbed Sleep (DFUS)
DFUS will be assessed during the 2-week treatment period with one of three dose levels of Paxerol vs. placebo
Measured: Up to 2 weeks
Total Hours of Nightly Sleep
The total hours of nightly sleep will be assessed during the 2-week treatment period with one of three dose levels of Paxerol vs. placebo
Measured: Up to 2 weeks

Timeline

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

Jan 2016Nov 2017

First posted6 Jan 2016 (estimated)
Study startJan 2016
Primary completionOct 2017
Study completionNov 2017

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for NocturiaStudies 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02646826
Sponsor's protocol ID: CL-Paxerol-002
Status last verified: Jun 2019
First submitted: 30 Dec 2015
Last updated: 14 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Lee KC, Rauscher F, Kaminesky J, Ryndin I, Xie L, Zhao Y, Khusid JA, Weiss JP. Novel immediate/sustained-release formulation of acetaminophen-ibuprofen combination (Paxerol(R)) for severe nocturia associated with overactive bladder: A multi-center, randomized, double blinded, placebo-controlled, 4-arm trial. Neurourol Urodyn. 2019 Feb;38(2):740-748. doi: 10.1002/nau.23910. Epub 2018 Dec 28.
PubMed 30592553

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

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All Nocturia trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Paxerol™ (a Novel Formulation of Acetaminophen and Ibuprofen) for Treatment of Nocturia - A Phase II Placebo-Controlled Trial
ClinicalTrials.gov ID: NCT02646826
Acronym / sponsor ID: CL-Paxerol-002
Conditions: Nocturia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 86 participants (actual)
Lead sponsor: Wellesley Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
Study start: Jan 2016
Primary completion: Oct 2017 (actual)
Study completion: Nov 2017 (actual)
First posted: 6 Jan 2016 (estimated)
Results: Posted 14 Jun 2019

Clinical summary

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

Detailed description

The co-primary objectives are:

To assess the effect of different doses of Paxerol on the reduction in the number of nocturia episodes.
To assess the clinical benefit of different doses of Paxerol in reducing nocturia via assessment of nocturia quality of life (NQOL).

The secondary objectives are to assess the effects of different doses of Paxerol on:

Duration of First Undisturbed Sleep (DFUS) B. Total hours of nightly sleep C. Safety and tolerability

An exploratory assessment is to evaluate baseline urinary PGE2 production on the responsiveness of subjects to Paxerol.

Study duration for each subject is approximately 4 weeks, which includes screening, baseline assessment, two weeks of treatment with study drugs, and follow-up.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Other: PlaceboSubjects are treated with placebo tablets.
Paxerol - Dose Level 1	Experimental	Drug: Paxerol - Dose Level 1Subjects are treated with the first dose level of Paxerol.
Paxerol - Dose Level 2	Experimental	Drug: Paxerol - Dose Level 2Subjects are treated with the second dose level of Paxerol.
Paxerol - Dose Level 3	Experimental	Drug: Paxerol - Dose Level 3Subjects are treated with the third dose level of Paxerol.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Subjects diagnosed with nocturia, as defined by International Continence Society (i.e., the interruption of sleep one or more times at night to void), confirmed by evaluation in participating investigator's urology practice for the following characteristics: nocturia is related to overactive bladder (OAB); nightly ≥2.5 times nocturia present for at least 3 months and not considered caused by persistent or recurrent urinary tract infection; Post-Void Residual (PVR) urine volume must be <80 cc at the time of screening; did not respond well to, or unwilling to have, lifestyle modification, behavioral and conservative therapies, such as dietary changes, timed voiding, urge suppression (e.g., pelvic floor exercises [PFE] at the time of urge episodes), biofeedback, etc.
Males or females, ≥18 years of age with Body Mass Index (BMI) <40.
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation.
Ability to understand and sign the study Informed Consent Form (ICF), communicate with the investigators, and understand and comply with the requirements of the protocol, including completion of participation in all phases of the study.
No current or medical history of gastrointestinal bleeding or malformation; bleeding diathesis; or restless leg syndrome.

Key exclusion criteria (24 listed)

Pregnant or nursing women.
Known presence of urinary tract infection (UTI) within 4 weeks before study initiation
Known sleep interruptions due to sleep apnea, dyspepsia or other gastro-intestinal symptoms, seizure disorders or other neurologic symptoms
Allergy to or intolerance of acetaminophen, ibuprofen, or any inactive component of the study drug formulations.
A history of allergy to aspirin or other NSAIDs.

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
PlaceboAlso: Placebo controlSubjects are treated with Placebo tablets	Other	Placebo
Paxerol - Dose Level 1Also: Treatment arm 1Subjects are treated with the first dose level of Paxerol	Drug	Paxerol - Dose Level 1
Paxerol - Dose Level 2Also: Treatment arm 2Subjects are treated with the second dose level of Paxerol	Drug	Paxerol - Dose Level 2
Paxerol - Dose Level 3Also: Treatment arm 3Subjects are treated with the third dose level of Paxerol	Drug	Paxerol - Dose Level 3

Primary outcome

Change in Nocturia Episodes
Time frame: Up to 2 weeks
Change in number of nocturia episodes associated with one of three dose levels of Paxerol vs. placebo is assessed during the 2-week treatment period.
Clinical Benefit Based on Nocturia Quality of Life (NQOL).
Time frame: Up to 2 weeks
The degree of clinical benefit, via NQOL, associated with one of three dose levels of Paxerol vs. placebo is assessed after the 2-week treatment period. This is on a scale of 0 to 100, with 0 being the best score.

2 secondary outcomes

Duration of First Undisturbed Sleep (DFUS)
Time frame: Up to 2 weeks
Total Hours of Nightly Sleep
Time frame: Up to 2 weeks

Results and safety

Results posted to the registry on 14 Jun 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
Placebo	21	19
Paxerol - Dose Level 1 325 mg Acetaminophen 150 mg Ibuprofen	22	22
Paxerol - Dose Level 2 650 mg Acetaminophen 300 mg Ibuprofen	21	20
Paxerol - Dose Level 3 975 mg Acetaminophen 450 mg Ibuprofen	22	21

Primary outcome: Change in Nocturia Episodes

Time frame: Up to 2 weeks. Mean (Standard Deviation). Unit: average nightly voids

Measure	Placebo n = 21	Paxerol - Dose Level 1 325 mg Acetaminophen 150 mg Ibuprofen n = 22	Paxerol - Dose Level 2 650 mg Acetaminophen 300 mg Ibuprofen n = 21	Paxerol - Dose Level 3 975 mg Acetaminophen 450 mg Ibuprofen n = 22
Baseline	3.6 (0.7)	3.3 (1.0)	3.9 (1.4)	3.6 (1.0)
Two Weeks Using Pills	3.2 (1.0)	2.2 (1.0)	2.5 (1.0)	2.4 (1.0)
Change of Nocturia Episodes	-0.3 (0.7)	-1.1 (0.7)	-1.4 (1.4)	-1.3 (0.8)

Placebo vs Paxerol - Dose Level 1 325 mg Acetaminophen 150 mg Ibuprofen vs Paxerol - Dose Level 2 650 mg Acetaminophen 300 mg Ibuprofen vs Paxerol - Dose Level 3 975 mg Acetaminophen 450 mg Ibuprofen: p = 0.0017, ANOVA

Primary outcome: Clinical Benefit Based on Nocturia Quality of Life (NQOL).

Time frame: Up to 2 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo n = 21	Paxerol - Dose Level 1 325 mg Acetaminophen 150 mg Ibuprofen n = 22	Paxerol - Dose Level 2 650 mg Acetaminophen 300 mg Ibuprofen n = 21	Paxerol - Dose Level 3 975 mg Acetaminophen 450 mg Ibuprofen n = 22
Baseline Quality of Life	52.5 (15.2)	52.3 (20.4)	63.6 (19.6)	59.7 (20.7)
Two Weeks Using Pills	42.1 (18.3)	40.7 (21.4)	40.5 (18.1)	37.4 (23.4)

Placebo vs Paxerol - Dose Level 1 325 mg Acetaminophen 150 mg Ibuprofen vs Paxerol - Dose Level 2 650 mg Acetaminophen 300 mg Ibuprofen vs Paxerol - Dose Level 3 975 mg Acetaminophen 450 mg Ibuprofen: p <.44, ANOVA

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were tracked during the 4 week study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 21 (0%)	4 of 21 (19%)	0 of 21
Paxerol - Dose Level 1 325 mg Acetaminophen 150 mg Ibuprofen	0 of 22 (0%)	2 of 22 (9.1%)	0 of 22
Paxerol - Dose Level 2 650 mg Acetaminophen 300 mg Ibuprofen	0 of 21 (0%)	3 of 21 (14.3%)	0 of 21
Paxerol - Dose Level 3 975 mg Acetaminophen 450 mg Ibuprofen	0 of 22 (0%)	3 of 22 (13.6%)	0 of 22

Limitations and caveats (from the sponsor): None of the adverse events were considered to be drug related.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30592553Lee KC, Rauscher F, Kaminesky J, Ryndin I, Xie L, Zhao Y, Khusid JA, Weiss JP. Novel immediate/sustained-release formulation of acetaminophen-ibuprofen combination (Paxerol(R)) for severe nocturia associated with overactive bladder: A multi-center, randomized, double blinded, placebo-controlled, 4-arm trial. Neurourol Urodyn. 2019 Feb;38(2):740-748. doi: 10.1002/nau.23910. Epub 2018 Dec 28.
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.

David A Dill study chair

Wellesley Pharmaceuticals

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paxerol - Dose Level 1, Paxerol - Dose Level 2 and Paxerol - Dose Level 3 in people with Nocturia, run by Wellesley Pharmaceuticals, LLC at 4 sites 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 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 14 Jun 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?

Change in Nocturia Episodes (time frame: Up to 2 weeks). The study lists 2 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 NCT02646826, 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 14 Jun 2019.