FeverPhase 3NCT01002573
Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
A Phase 3 study testing ibuprofen and acetaminophen in people with Fever, run by Cumberland Pharmaceuticals at 17 sites in United States.
Trial summary
The primary objective of the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever during the first two hours of treatment. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Fever
- What is being tested?
- ibuprofen and acetaminophen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 17 sitesUnited States
- Study dates
- Jul 2010to Jun 2013
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or study-only related procedures.
- Be between birth (28 weeks to < 40 weeks gestational age) to ≤ 16 years of age.
- Have new (less than 7 days) onset of fever, documented by temperature greater than or equal to 101.0 ºF (38.3 ºC).
Who cannot join
- Have inadequate intravenous access.
- Have received antipyretic drug therapy within 2 hours before dosing.
- Have any history of allergy or hypersensitivity to NSAIDs or aspirin.
- Have received another investigational drug within the past 30 days.
- Be otherwise unsuitable for the study, in the opinion of the Investigator.
- Have a fever due to hyperthermia.
- Pregnant or nursing.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Joseph M. Still Burn Center
Augusta, Georgia, 30909
Children's Medical Center Dallas
Dallas, Texas, 75235
Children's Hospital of Michigan
Detroit, Michigan, 48201
Children's Memorial Hermann Hospital
Houston, Texas, 77030
Texas Children's Hospital
Houston, Texas, 77030
Loma Linda University Medical Center
Loma Linda, California, 92354
Kosair Children's Hospital
Louisville, Kentucky, 40202
LeBonheur Children's Hospital
Memphis, Tennessee, 38103
Jackson Memorial Hospital (U. Miami)
Miami, Florida, 33136
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121-2483
Children's Hospital of Orange County
Orange, California, 92868
Florida Hospital
Orlando, Florida, 32804
Maricopa Medical Center
Phoenix, Arizona, 85008
LSU Health Sciences Center
Shreveport, Louisiana, 71103
Staten Island University Hospital
Staten Island, New York, 10305
The Children's Hospital at Saint Francis
Tulsa, Oklahoma, 74136
Howard University
Washington D.C., District of Columbia, 20060
About this study
Official title: A Multicenter, Randomized, Open-Label, Parallel, Active-Comparator Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Pediatric Patients
The primary objective of the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever during the first two hours of treatment.
Read the detailed description
The primary objective of the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever as measured by the area under the change in temperature versus time curve during the first 2 hours of treatment.
- Conditions
- Fever
- Being tested
- ibuprofen, acetaminophen
- Keywords
- Pediatric, Fever
- Medical subject headings
- 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
acetaminophenDrug
Also called APAP (acetaminophen), paracetamol
Acetaminophen, 10mg/kg
| Study group | Role | What they receive |
|---|---|---|
| ibuprofen | Experimental | Ibuprofen, 10 mg/kg Receives: Drug: ibuprofen |
| Acetaminophen | Active comparator | Acetaminophen, 10mg/kg Receives: Drug: acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fever Reduction
Treatment of fever as measured by the area under the change in temperature versus time curve during the first two hours of treatment (AUC0-2)
Measured: 0 to 2 hours post-dose
Secondary outcomes (6)
Change From Baseline in Temperature After the First 30 Minutes of Treatment
Change in temperature in patients receiving intravenous ibuprofen and acetaminophen (APAP) after the first 30 minutes of treatment.
Measured: 30 minutes following treatment
Change From Baseline in Temperature After the First 60 Minutes of Treatment
Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 60 minutes of treatment.
Measured: 60 minutes following treatment
Change in Temperature
Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 4 hours of treatment.
Measured: 4 hours following treatment
Change From Baseline in Temperature After the First Four Hours of Treatment
Change in temperature during the first 4 hours of treatment by assessing the area under the change in temperature versus time curve during the first four hours of treatment (AUC0-4)
Measured: 0 to 4 hours post-dose
Time to Afebrility (in Hours)
Tme to afebrility (temperature less than 100.4 ºF [38 ºC]) in patients receiving intravenous ibuprofen and APAP.
Measured: 4 Hour post treatment
Number of Afebrile and Febrile Subject at 4 Hours Post-Dose
Number of Afebrile and Febrile Subject at 4 Hours Following Treatment
Measured: 4 Hours Post-Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startJul 2010
- Primary completionJun 2013
- Study completionJun 2013
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.
- 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
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Art Wheeler, M.D., Study director, Cumberland Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002573
- Sponsor's protocol ID
- CPI-CL-012
- Status last verified
- Sep 2016
- First submitted
- 26 Oct 2009
- Last updated
- 7 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Khalil SN, Hahn BJ, Chumpitazi CE, Rock AD, Kaelin BA, Macias CG. A multicenter, randomized, open-label, active-comparator trial to determine the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for treatment of fever in hospitalized pediatric patients. BMC Pediatr. 2017 Feb 1;17(1):42. doi: 10.1186/s12887-017-0795-y.
PubMed 28143430
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-Label, Parallel, Active-Comparator Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Pediatric Patients
- ClinicalTrials.gov ID
- NCT01002573
- Acronym / sponsor ID
- CPI-CL-012
- Conditions
- Fever
- Keywords
- Pediatric, Fever
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Oct 2009 (estimated)
- Results
- Posted 7 Nov 2016
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 the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever during the first two hours of treatment.
Detailed description
The primary objective of the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever as measured by the area under the change in temperature versus time curve during the first 2 hours of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ibuprofen | Experimental | Drug: ibuprofenIbuprofen, 10 mg/kg |
| Acetaminophen | Active comparator | Drug: acetaminophenAcetaminophen, 10mg/kg |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or study-only related procedures.
- Be between birth (28 weeks to < 40 weeks gestational age) to ≤ 16 years of age.
- Have new (less than 7 days) onset of fever, documented by temperature greater than or equal to 101.0 ºF (38.3 ºC).
Key exclusion criteria (7 listed)
- Have inadequate intravenous access.
- Have received antipyretic drug therapy within 2 hours before dosing.
- Have any history of allergy or hypersensitivity to NSAIDs or aspirin.
- Have received another investigational drug within the past 30 days.
- Be otherwise unsuitable for the study, in the opinion of the Investigator.
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 |
| acetaminophenAlso: APAP (acetaminophen), paracetamolAcetaminophen, 10mg/kg | Drug | Acetaminophen |
Primary outcome
Fever Reduction
Time frame: 0 to 2 hours post-dose
Treatment of fever as measured by the area under the change in temperature versus time curve during the first two hours of treatment (AUC0-2)
6 secondary outcomes
Change From Baseline in Temperature After the First 30 Minutes of Treatment
Time frame: 30 minutes following treatment
Change From Baseline in Temperature After the First 60 Minutes of Treatment
Time frame: 60 minutes following treatment
Change in Temperature
Time frame: 4 hours following treatment
Change From Baseline in Temperature After the First Four Hours of Treatment
Time frame: 0 to 4 hours post-dose
Time to Afebrility (in Hours)
Time frame: 4 Hour post treatment
Number of Afebrile and Febrile Subject at 4 Hours Post-Dose
Time frame: 4 Hours Post-Dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28143430Khalil SN, Hahn BJ, Chumpitazi CE, Rock AD, Kaelin BA, Macias CG. A multicenter, randomized, open-label, active-comparator trial to determine the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for treatment of fever in hospitalized pediatric patients. BMC Pediatr. 2017 Feb 1;17(1):42. doi: 10.1186/s12887-017-0795-y.
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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.
Art Wheeler, M.D. study director
Cumberland Pharmaceuticals
17 sites 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 and acetaminophen in people with Fever, run by Cumberland Pharmaceuticals at 17 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 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 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 Nov 2016). 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?
Fever Reduction (time frame: 0 to 2 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 NCT01002573, 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 Nov 2016.