PainPhase 4NCT02583399

Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

A Phase 4 study testing Ibuprofen in people with Pain and Fever, run by Cumberland Pharmaceuticals 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

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Trial summary

The primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of intravenous ibuprofen administered over approximately ten (10) minutes. Read more about this study

Who is it for?: Ages Up to 6 months
Conditions the study is for: Pain, Fever
What is being tested?: Ibuprofen
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 4 sitesUnited States
Study dates: 8 Aug 2017to 2 Jul 2019
Phase: Phase 4
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 Up to 6 months
All sexes
No healthy volunteers
Child

Who may be able to join

Be a hospitalized male or female subject between birth (> 37 weeks gestational age) and < six (6) months of age.
Have a clinical indication of pain or fever.
Have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or performance of any study-only related procedures.

Who cannot join

Have inadequate intravenous access.
Have an uncorrected ductus dependent congenital heart disease.
Have any history of allergy or hypersensitivity to non-steroidal anti-inflammatory drug or aspirin.
Have a current history of uncorrected hypovolemia or acute renal disease.
Have a current history of acute liver disease.
Have received NSAID, acetaminophen, or aspirin drug therapy within four hours prior to dosing. Have received another investigational drug within the past 30 days.
Be otherwise unsuitable for the study, in the opinion of the Investigator.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Children's Medical Center Dallas
Dallas, Texas, 75235
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Kosair Charaties Pediatric Research Unit
Louisville, Kentucky, 40202

Other trials in United States

About this study

Official title: A Multi-Center, Open-Label Pharmacokinetic and Safety Study for Reduction in Fever or Management of Pain in Pediatric Subjects Aged Birth to Six Months

The primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of intravenous ibuprofen administered over approximately ten (10) minutes.

Read the detailed description

The primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of intravenous ibuprofen administered over approximately ten (10) minutes.

Conditions: Pain, Fever
Being tested: Ibuprofen
Keywords: Pediatric (Birth to less than 6 months of age), Pain, Fever
Medical subject headings: Pain, Fever

What participants receive

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

IbuprofenDrug
Ibuprofen, 10 mg/kg

Study groups in NCT02583399
Study group	Role	What they receive
Ibuprofen	Experimental	Ibuprofen, 10 mg/kg Receives: Drug: Ibuprofen

What is being measured

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

Area Under the Curve (AUC) 0-4 Hours of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.
This outcome measurement was to the determine the area under the plot of plasma concentrations of drug against time after drug administration. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours.
Measured: 4 hours
Maximum Observed Plasma Concentration (Cmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.
This outcome measurement was to measure the maximal or peak measured serum concentration (Cmax) of a single dose of intravenous ibuprofen (IVIb) after its administration. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours.
Measured: 4 hours
Elimination Half Life (T 1/2) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.
This outcome measurement was to determine the half-life or the period of time required for the concentration or amount of drug in the body to be reduced to exactly one-half of a given concentration or amount. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours.
Measured: 4 hours
Time to Maximum Concentration (Tmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.
This outcome measurement was to determine the time to maximum concentration (Tmax) of a single dose of intravenous ibuprofen (IVIb) after its administration. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours.
Measured: 4 hours

Timeline

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

8 Aug 20172 Jul 2019

First posted22 Oct 2015 (estimated)
Study start8 Aug 2017
Primary completion2 Jul 2019
Study completion2 Jul 2019

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 PainStudies 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Multi-center, Open-label
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02583399
Sponsor's protocol ID: CPI-CL-022
Status last verified: Oct 2020
First submitted: 20 Oct 2015
Last updated: 20 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Glover CD, Berkenbosch JW, Taylor MB, Patel NV, Kaelin B, Gibson BHY, Zhong J. A Multi-Center Evaluation of the Pharmacokinetics and Safety of Intravenous Ibuprofen in Infants 1-6 Months of Age. Paediatr Drugs. 2023 Sep;25(5):585-593. doi: 10.1007/s40272-023-00576-9. Epub 2023 Jun 9.
PubMed 37294477

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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Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Open-Label Pharmacokinetic and Safety Study for Reduction in Fever or Management of Pain in Pediatric Subjects Aged Birth to Six Months
ClinicalTrials.gov ID: NCT02583399
Acronym / sponsor ID: CPI-CL-022
Conditions: Pain, Fever
Keywords: Pediatric (Birth to less than 6 months of age), Pain, Fever
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 8 Aug 2017 (actual)
Primary completion: 2 Jul 2019 (actual)
Study completion: 2 Jul 2019 (actual)
First posted: 22 Oct 2015 (estimated)
Results: Posted 20 Nov 2020

Clinical summary

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

The primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of intravenous ibuprofen administered over approximately ten (10) minutes.

Detailed description

The primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of intravenous ibuprofen administered over approximately ten (10) minutes.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Multi-center, Open-label

Arm	Type	Receives
Ibuprofen	Experimental	Drug: IbuprofenIbuprofen, 10 mg/kg

Who may qualify

Ages: Up to 6 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Be a hospitalized male or female subject between birth (> 37 weeks gestational age) and < six (6) months of age.
Have a clinical indication of pain or fever.
Have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or performance of any study-only related procedures.

Key exclusion criteria (7 listed)

Have inadequate intravenous access.
Have an uncorrected ductus dependent congenital heart disease.
Have any history of allergy or hypersensitivity to non-steroidal anti-inflammatory drug or aspirin.
Have a current history of uncorrected hypovolemia or acute renal disease.
Have a current history of acute liver disease.

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
IbuprofenIbuprofen, 10 mg/kg	Drug	Ibuprofen

Primary outcome

Area Under the Curve (AUC) 0-4 Hours of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.
Time frame: 4 hours
This outcome measurement was to the determine the area under the plot of plasma concentrations of drug against time after drug administration. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours.
Maximum Observed Plasma Concentration (Cmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.
Time frame: 4 hours
This outcome measurement was to measure the maximal or peak measured serum concentration (Cmax) of a single dose of intravenous ibuprofen (IVIb) after its administration. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours.
Elimination Half Life (T 1/2) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.
Time frame: 4 hours
This outcome measurement was to determine the half-life or the period of time required for the concentration or amount of drug in the body to be reduced to exactly one-half of a given concentration or amount. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours.
Time to Maximum Concentration (Tmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.
Time frame: 4 hours
This outcome measurement was to determine the time to maximum concentration (Tmax) of a single dose of intravenous ibuprofen (IVIb) after its administration. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours.

Results and safety

Results posted to the registry on 20 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ibuprofen	30	24

Primary outcome: Area Under the Curve (AUC) 0-4 Hours of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.

Time frame: 4 hours. Mean (Standard Error). Unit: mcg*hr/mL

Measure	Ibuprofen n = 24
Value	75.74 (4.09)

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.

Time frame: 4 hours. Mean (Standard Error). Unit: microgram/milliliter

Measure	Ibuprofen n = 24
Value	56.28 (2.77)

Primary outcome: Elimination Half Life (T 1/2) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.

Time frame: 4 hours. Number. Unit: hours

Measure	Ibuprofen n = 24
Value	1.30

Population analysed: Analysis were performed using sparse sampling concentration. Phoenix WinNonlin treats the sparse data as a special case of plasma concentration data. The NCA sparse methodology calculates PK parameters based on the mean profile for all the subjects in the dataset. Consequently, standard deviation can only be calculated based on observed data (AUC0-t and Cmax) but not on derived data (Tmax, T½ el.)

Primary outcome: Time to Maximum Concentration (Tmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.

Time frame: 4 hours. Number. Unit: minutes

Measure	Ibuprofen n = 24
Value	10

Adverse events

Time frame: Adverse events were assessed during the treatment period beginning with the start of the study drug administration through study hour 72 or until discharge, whichever occurs first.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ibuprofen	1 of 24 (4.2%)	7 of 24 (29.2%)	8 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37294477Glover CD, Berkenbosch JW, Taylor MB, Patel NV, Kaelin B, Gibson BHY, Zhong J. A Multi-Center Evaluation of the Pharmacokinetics and Safety of Intravenous Ibuprofen in Infants 1-6 Months of Age. Paediatr Drugs. 2023 Sep;25(5):585-593. doi: 10.1007/s40272-023-00576-9. Epub 2023 Jun 9.
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.

Todd Rice, MD study chair

Vanderbilt University

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ibuprofen in people with Pain and Fever, run by Cumberland Pharmaceuticals 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 3 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 20 Nov 2020. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 20 Nov 2020). 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?

Area Under the Curve (AUC) 0-4 Hours of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. (time frame: 4 hours). 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 NCT02583399, 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 20 Nov 2020.