FeverPhase 3NCT02761980

A Study of Ibuprofen 250 mg / Acetaminophen 500 mg Comparing The Antipyretic Effects in Healthy Male Volunteers

A Phase 3 study testing Ibuprofen 250 mg / Acetaminophen 500 mg, Ibuprofen 250 mg and Acetaminophen 500 mg in people with Fever, run by Pfizer at 1 site in United States.

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

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Fever
What is being tested?: Ibuprofen 250 mg / Acetaminophen 500 mg, Ibuprofen 250 mg and Acetaminophen 500 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 290 participants
Where: 1 siteUnited States
Study dates: 6 Dec 2016to 6 Dec 2017
Phase: Phase 3
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 male subjects who, at the time of screening, are between 18 and 55 years of age, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.
The subject must have a normal, stable body temperature at Screening and on Day 0. If the subject's oral temperature is not between 97.4°F and 98.8°F, then 2 additional oral temperature readings will be obtained within a 30 minute period. These 3 consecutive temperature readings must be between 97.4°F and 98.8°F, with the highest value within 0.4°F of the lowest temperature value.
Body Mass Index (BMI) of 17.5 to 37.0 kg/m2; and a total body weight 50 kg (110 lbs) at Screening.
The subject has demonstrably adequate veins, by visual inspection, for IV catheter insertion.

Who cannot join

Evidence or history of clinically significant laboratory abnormality, hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (excluding untreated, asymptomatic, seasonal allergies at the time of dosing) within the last 5 years that may increase the risk associated with study participation.
Subjects with any gastrointestinal disorders (eg, gastrectomy, tracheostomy, esophageal surgeries, short gut syndrome, peptic ulcer disease, known or suspected obstructive disease, previous gastrointestinal surgery, felinization of the esophagus, hypomotility of the gastrointestinal track) that could affect the absorption, metabolism, or excretion of the study medication or affect the results of the ingestible thermometer.
Subjects at risk for excessive bleeding.
Subjects with a history of nasal polyps, angioedema, or significant or actively treated bronchospastic disease.
Screening supine blood pressure ≤90 or ≥140 mm Hg (systolic) or ≤50 or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If blood pressure (BP) is ≤90 or ≥140 mm Hg (systolic) or ≤50 or ≥90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three consecutive BP values should be used to determine the subject's eligibility.
Screening supine 12 lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec at Screening and on Day 1 prior to RSE administration. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three consecutive QTc or QRS values should be used to determine the subject's eligibility.

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The subject has a history of recurrent or acute or chronic infections of any type or any findings suggestive of occult infection, such as tuberculosis, sinusitis, urinary tract infection, respiratory tract or dental (abscess) infection, etc., or those with a positive QuantiFERON Tuberculosis, Hepatitis B surface antigen, Hepatitis C antibody, and/or Human immunodeficiency virus (HIV) test at Screening. Also excluded are subjects with frequent (more than 3 outbreaks per year), recurrent oral or genital herpes, recurrent herpes zoster, or any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the study.
Subjects who have experienced cold/flu symptoms (ie, runny nose, cough, and/or fever) within 2 weeks prior to the first administration of study treatments.
Subjects with a reduction in heart rate to ≤50 beats per minute or deemed to be at high risk of syncope and/or hypotension per the clinical judgment of the investigator following a carotid sinus massage procedure.

Trial locations and contacts

1 site in 1 country.

United States1 site

New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920

Other trials in United States

About this study

Official title: A Phase 3, Double-blind, Randomized, Placebo-controlled, Full Factorial, Safety And Efficacy Study Comparing The Antipyretic Effects Of A Single Oral Dose Of Ibuprofen (Ibu) 250 Mg/ Acetaminophen (Apap) 500 Mg Caplets To Ibu 250 Mg And Apap 500 Mg Caplets In Healthy Male Volunteers With Fever Induced By An Endotoxin

This is a single dose study that will evaluate the efficacy and safety of a Fixed Dose Combination Ibuprofen 250 mg/ Acetaminophen 500 mg tablet in healthy male patients with fever. Results for the Fixed Dose Combination product will be compared to the individual components Ibuprofen 250 mg and Acetaminophen 500 mg and also compared to placebo.

Conditions: Fever
Being tested: Ibuprofen 250 mg / Acetaminophen 500 mg, Ibuprofen 250 mg, Acetaminophen 500 mg, Placebo
Keywords: ibuprofen; acetaminophen; induced fever; fever
Medical subject headings: Fever

What participants receive

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

Ibuprofen 250 mg / Acetaminophen 500 mgDrug
Also called IBU 250 / APAP 500
Ibuprofen 250 mg / Acetaminophen 500 mg
Ibuprofen 250 mgDrug
Also called IBU 250
Ibuprofen 250 mg
Acetaminophen 500 mgDrug
Also called APAP 500
1 APAP 500 mg caplet
PlaceboDrug
Placebo tablet

Study groups in NCT02761980
Study group	Role	What they receive
Ibuprofen 250 mg / Acetaminophen 500 mg	Experimental	Single dose of 2 caplets of Ibuprofen 125 mg / Acetaminophen 250 mg by mouth Receives: Drug: Ibuprofen 250 mg / Acetaminophen 500 mg
Ibuprofen 250 mg	Active comparator	Single dose of 2 caplets of IBU 125 mg by mouth Receives: Drug: Ibuprofen 250 mg
Acetaminophen 500 mg	Active comparator	Single dose of 1 APAP 500 mg caplet + 1 placebo caplet by mouth Receives: Drug: Acetaminophen 500 mg
Placebo	Placebo comparator	Single dose of 2 caplets of Placebo by mouth Receives: Drug: Placebo

What is being measured

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

Time Weighted Sum of Temperature Difference (WSTD) From 0 to 8 Hours
WSTD 0-8 was defined as time-weighted sum of temperature differences over 8 hours, weighted by time elapsed between each 2 consecutive time points post treatment (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours). Temperature difference was defined as baseline temperature (at 0 hour) minus the post-baseline temperature at each time point up to 8 hours (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours).
Measured: 0 to 8 hours post-dose

Secondary outcomes (4)

Time Weighted Sum of Temperature Differences (WSTD) From Baseline Through Hours 2, 4 and 6
WSTD 0-2, 0-4 and 0-6 was defined as time-weighted sum of temperature differences over each specified time interval (0-2 hour, 0-4 hour and 0-6 hour), weighted by time elapsed between each 2 consecutive time points post treatment (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour), within each time interval. Temperature difference was defined as baseline temperature (at 0 hour) minus the post-baseline temperature at each time point within each specified time interval: 1) 0-2 hour (20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes) , 2) 0-4 hour (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4 hour), 3) 0-6 hour (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour).
Measured: 0 to 2 hours postdose, 0 to 4 hours postdose, 0 to 6 hours postdose
Time to Return to Normal Body Temperature
Time to return to normal body temperature was defined as time from initial measurement of normal body temperature (at baseline; before administration of first test dose of RSE to induce pyrexia) till the time at which normal temperature was achieved again after pyrexia. Normal body temperature was defined as the last non-missing body temperature value, assessed prior to or at the time of first RSE test dose.
Measured: Baseline (pre-dose) up to 8 hours post dose
Time to Rescue Medication
Time to rescue medication (other than study treatment) (in minutes) was defined as time from first dosing of study medication to the time a participant first takes a rescue medication, or to the end of the study time for participants that do not take any rescue medication prior to the end of the study. The rescue medication was defined as medication received for the treatment of fever during the time period from the administration of study medication to the time of end of the study.
Measured: 0 to 8 hours post dose
Time Weighted Sum of Temperature Difference From 6 to 8 Hours
WSTD 6-8 was defined as time-weighted sum of temperature differences between 6 to 8 hours post-dose, weighted by time elapsed between each 2 consecutive time points within 6 to 8 hours (6.5, 7, 7.5 and 8 hours). Temperature difference was defined as temperature at 6 hours minus the temperature at specified time points (6.5, 7, 7.5 and 8 hours).
Measured: 6 to 8 hours postdose

Timeline

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

6 Dec 20166 Dec 2017

First posted4 May 2016 (estimated)
Study start6 Dec 2016
Primary completion6 Dec 2017
Study completion6 Dec 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 FeverStudies of the same condition, open and under way.
More trials run by PfizerThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 290 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02761980
Sponsor's protocol ID: B5061002
Other IDs: GEMINI IF
Status last verified: Nov 2018
First submitted: 2 May 2016
Last updated: 7 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests

Publications

Smith W, Leyva R, Kellstein D, Arthur E, Cruz-Rivera M. Efficacy of a Fixed-Dose Combination of Ibuprofen and Acetaminophen Compared With Individual Monocomponents in Adult Male Subjects With Endotoxin-Induced Fever: A Randomized Controlled Trial. Clin Ther. 2021 Jul;43(7):1213-1227. doi: 10.1016/j.clinthera.2021.05.004. Epub 2021 Jul 23.
PubMed 34304913

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 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Double-blind, Randomized, Placebo-controlled, Full Factorial, Safety And Efficacy Study Comparing The Antipyretic Effects Of A Single Oral Dose Of Ibuprofen (Ibu) 250 Mg/ Acetaminophen (Apap) 500 Mg Caplets To Ibu 250 Mg And Apap 500 Mg Caplets In Healthy Male Volunteers With Fever Induced By An Endotoxin
ClinicalTrials.gov ID: NCT02761980
Acronym / sponsor ID: B5061002
Conditions: Fever
Keywords: ibuprofen; acetaminophen; induced fever; fever
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 290 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 6 Dec 2016 (actual)
Primary completion: 6 Dec 2017 (actual)
Study completion: 6 Dec 2017 (actual)
First posted: 4 May 2016 (estimated)
Results: Posted 7 Dec 2018

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Ibuprofen 250 mg / Acetaminophen 500 mg	Experimental	Drug: Ibuprofen 250 mg / Acetaminophen 500 mgSingle dose of 2 caplets of Ibuprofen 125 mg / Acetaminophen 250 mg by mouth
Ibuprofen 250 mg	Active comparator	Drug: Ibuprofen 250 mgSingle dose of 2 caplets of IBU 125 mg by mouth
Acetaminophen 500 mg	Active comparator	Drug: Acetaminophen 500 mgSingle dose of 1 APAP 500 mg caplet + 1 placebo caplet by mouth
Placebo	Placebo comparator	Drug: PlaceboSingle dose of 2 caplets of Placebo by mouth

Who may qualify

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

Key inclusion criteria (4 listed)

Healthy male subjects who, at the time of screening, are between 18 and 55 years of age, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.
The subject must have a normal, stable body temperature at Screening and on Day 0. If the subject's oral temperature is not between 97.4°F and 98.8°F, then 2 additional oral temperature readings will be obtained within a 30 minute period. These 3 consecutive temperature readings must be between 97.4°F and 98.8°F, with the highest value within 0.4°F of the lowest temperature value.
Body Mass Index (BMI) of 17.5 to 37.0 kg/m2; and a total body weight 50 kg (110 lbs) at Screening.
The subject has demonstrably adequate veins, by visual inspection, for IV catheter insertion.

Key exclusion criteria (9 listed)

Evidence or history of clinically significant laboratory abnormality, hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (excluding untreated, asymptomatic, seasonal allergies at the time of dosing) within the last 5 years that may increase the risk associated with study participation.
Subjects with any gastrointestinal disorders (eg, gastrectomy, tracheostomy, esophageal surgeries, short gut syndrome, peptic ulcer disease, known or suspected obstructive disease, previous gastrointestinal surgery, felinization of the esophagus, hypomotility of the gastrointestinal track) that could affect the absorption, metabolism, or excretion of the study medication or affect the results of the ingestible thermometer.
Subjects at risk for excessive bleeding.
Subjects with a history of nasal polyps, angioedema, or significant or actively treated bronchospastic disease.
Screening supine blood pressure ≤90 or ≥140 mm Hg (systolic) or ≤50 or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If blood pressure (BP) is ≤90 or ≥140 mm Hg (systolic) or ≤50 or ≥90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three consecutive BP values should be used to determine the subject's eligibility.

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
Ibuprofen 250 mg / Acetaminophen 500 mgAlso: IBU 250 / APAP 500Ibuprofen 250 mg / Acetaminophen 500 mg	Drug	Ibuprofen 250 mg / Acetaminophen 500 mg
Ibuprofen 250 mgAlso: IBU 250Ibuprofen 250 mg	Drug	Ibuprofen 250 mg
Acetaminophen 500 mgAlso: APAP 5001 APAP 500 mg caplet	Drug	Acetaminophen 500 mg
PlaceboPlacebo tablet	Drug	Placebo

Primary outcome

Time Weighted Sum of Temperature Difference (WSTD) From 0 to 8 Hours
Time frame: 0 to 8 hours post-dose
WSTD 0-8 was defined as time-weighted sum of temperature differences over 8 hours, weighted by time elapsed between each 2 consecutive time points post treatment (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours). Temperature difference was defined as baseline temperature (at 0 hour) minus the post-baseline temperature at each time point up to 8 hours (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours).

4 secondary outcomes

Time Weighted Sum of Temperature Differences (WSTD) From Baseline Through Hours 2, 4 and 6
Time frame: 0 to 2 hours postdose, 0 to 4 hours postdose, 0 to 6 hours postdose
Time to Return to Normal Body Temperature
Time frame: Baseline (pre-dose) up to 8 hours post dose
Time to Rescue Medication
Time frame: 0 to 8 hours post dose
Time Weighted Sum of Temperature Difference From 6 to 8 Hours
Time frame: 6 to 8 hours postdose

Results and safety

Results posted to the registry on 7 Dec 2018, 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	29	25
Ibuprofen 250 mg+Acetaminophen 500 mg	87	80
Ibuprofen 250 mg	87	81
Acetaminophen 500 mg	87	81

Primary outcome: Time Weighted Sum of Temperature Difference (WSTD) From 0 to 8 Hours

Time frame: 0 to 8 hours post-dose. Mean (Standard Deviation). Unit: degrees fahrenheit

Measure	Placebo n = 27	Ibuprofen 250 mg+Acetaminophen 500 mg n = 81	Ibuprofen 250 mg n = 83	Acetaminophen 500 mg n = 82
Value	9.28 (6.395)	12.54 (5.519)	11.09 (6.355)	12.39 (6.278)

Placebo vs Ibuprofen 250 mg+Acetaminophen 500 mg: LSM difference: 3.14 (95% CI 1.13 to 5.15), p = 0.002, ANCOVA
Ibuprofen 250 mg+Acetaminophen 500 mg vs Ibuprofen 250 mg: LSM difference: 0.91 (95% CI -0.52 to 2.33), p = 0.210, ANCOVA
Ibuprofen 250 mg+Acetaminophen 500 mg vs Acetaminophen 500 mg: LSM difference: 0.79 (95% CI -0.64 to 2.21), p = 0.280, ANCOVA

Population analysed: Modified intent to treat (mITT) population included all randomized participants who were dosed with the study medication and RSE per procedures specified in protocol post amendment 4 and had a baseline assessment. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 24 hours after discharge (up to 32 hours). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 29 (0%)	1 of 29 (3.4%)	0 of 29
Ibuprofen 250 mg+Acetaminophen 500 mg	0 of 87 (0%)	1 of 87 (1.1%)	0 of 87
Ibuprofen 250 mg	0 of 87 (0%)	0 of 87 (0%)	0 of 87
Acetaminophen 500 mg	0 of 87 (0%)	0 of 87 (0%)	0 of 87

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34304913Smith W, Leyva R, Kellstein D, Arthur E, Cruz-Rivera M. Efficacy of a Fixed-Dose Combination of Ibuprofen and Acetaminophen Compared With Individual Monocomponents in Adult Male Subjects With Endotoxin-Induced Fever: A Randomized Controlled Trial. Clin Ther. 2021 Jul;43(7):1213-1227. doi: 10.1016/j.clinthera.2021.05.004. Epub 2021 Jul 23.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

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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.

Pfizer CT.gov Call Center study director

Pfizer

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ibuprofen 250 mg / Acetaminophen 500 mg, Ibuprofen 250 mg and Acetaminophen 500 mg in people with Fever, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 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 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 7 Dec 2018). 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?

Time Weighted Sum of Temperature Difference (WSTD) From 0 to 8 Hours (time frame: 0 to 8 hours post-dose). 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 NCT02761980, 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 7 Dec 2018.