Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

A Multicenter, Randomized, Open-Label, Parallel, Active-Comparator Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Pediatric Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01002573

Enrollment

118

Registered

2009-10-27

Start date

2010-07-31

Completion date

2013-06-30

Last updated

2016-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever

Keywords

Pediatric, Fever

Brief 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.

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.

Interventions

DRUGibuprofen

Ibuprofen, 10 mg/kg

DRUGacetaminophen

Acetaminophen, 10mg/kg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 16 Years

Healthy volunteers

Inclusion criteria

1. Have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or study-only related procedures. 2. Be between birth (28 weeks to \< 40 weeks gestational age) to ≤ 16 years of age. 3. Have new (less than 7 days) onset of fever, documented by temperature greater than or equal to 101.0 ºF (38.3 ºC).

Exclusion criteria

1. Have inadequate intravenous access. 2. Have received antipyretic drug therapy within 2 hours before dosing. 3. Have any history of allergy or hypersensitivity to NSAIDs or aspirin. 4. Have received another investigational drug within the past 30 days. 5. Be otherwise unsuitable for the study, in the opinion of the Investigator. 6. Have a fever due to hyperthermia. 7. Pregnant or nursing.

Design outcomes

Primary

Measure	Time frame	Description
Fever Reduction	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)

Secondary

Measure	Time frame	Description
Change From Baseline in Temperature After the First 60 Minutes of Treatment	60 minutes following treatment	Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 60 minutes of treatment.
Change in Temperature	4 hours following treatment	Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 4 hours of treatment.
Change From Baseline in Temperature After the First 30 Minutes of Treatment	30 minutes following treatment	Change in temperature in patients receiving intravenous ibuprofen and acetaminophen (APAP) after the first 30 minutes of treatment.
Time to Afebrility (in Hours)	4 Hour post treatment	Tme to afebrility (temperature less than 100.4 ºF \[38 ºC\]) in patients receiving intravenous ibuprofen and APAP.
Number of Afebrile and Febrile Subject at 4 Hours Post-Dose	4 Hours Post-Dose	Number of Afebrile and Febrile Subject at 4 Hours Following Treatment
Change From Baseline in Temperature After the First Four Hours of Treatment	0 to 4 hours post-dose	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)

Countries

United States

Participant flow

Participants by arm

Arm	Count
Ibuprofen Ibuprofen, 10 mg/kg ibuprofen: Ibuprofen, 10 mg/kg	47
Acetaminophen Acetaminophen, 10mg/kg acetaminophen: Acetaminophen, 10mg/kg	53
Total	100

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Subject did not receive at least 1 dose	11	7

Baseline characteristics

Characteristic	Ibuprofen	Acetaminophen	Total
Age, Customized 2 years to 6 years	13 participants	14 participants	27 participants
Age, Customized 6 months to 2 years	6 participants	14 participants	20 participants
Age, Customized 6 years to 16 years	28 participants	25 participants	53 participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants	24 Participants	53 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants	29 Participants	47 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	2 Participants	2 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	5 Participants	8 Participants	13 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) White	42 Participants	42 Participants	84 Participants
Sex: Female, Male Female	20 Participants	27 Participants	47 Participants
Sex: Female, Male Male	27 Participants	26 Participants	53 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	28 / 47	22 / 53
serious Total, serious adverse events	2 / 47	2 / 53

Outcome results

Primary

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)

Time frame: 0 to 2 hours post-dose