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

Primary Purpose

Fever

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ibuprofen
acetaminophen
Sponsored by
Cumberland Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fever focused on measuring Pediatric, Fever

Eligibility Criteria

undefined - 16 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Maricopa Medical Center
  • Loma Linda University Medical Center
  • Children's Hospital of Orange County
  • Howard University
  • Jackson Memorial Hospital (U. Miami)
  • Florida Hospital
  • Joseph M. Still Burn Center
  • Kosair Children's Hospital
  • Ochsner Clinic Foundation
  • LSU Health Sciences Center
  • Children's Hospital of Michigan
  • Staten Island University Hospital
  • The Children's Hospital at Saint Francis
  • LeBonheur Children's Hospital
  • Children's Medical Center Dallas
  • Children's Memorial Hermann Hospital
  • Texas Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ibuprofen

Acetaminophen

Arm Description

Ibuprofen, 10 mg/kg

Acetaminophen, 10mg/kg

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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.
Change in Temperature
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 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)
Time to Afebrility (in Hours)
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
Number of Afebrile and Febrile Subject at 4 Hours Following Treatment

Full Information

First Posted
October 26, 2009
Last Updated
September 22, 2016
Sponsor
Cumberland Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01002573
Brief Title
Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
Official Title
A Multicenter, Randomized, Open-Label, Parallel, Active-Comparator Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Pediatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cumberland Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever
Keywords
Pediatric, Fever

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ibuprofen
Arm Type
Experimental
Arm Description
Ibuprofen, 10 mg/kg
Arm Title
Acetaminophen
Arm Type
Active Comparator
Arm Description
Acetaminophen, 10mg/kg
Intervention Type
Drug
Intervention Name(s)
ibuprofen
Intervention Description
Ibuprofen, 10 mg/kg
Intervention Type
Drug
Intervention Name(s)
acetaminophen
Other Intervention Name(s)
APAP (acetaminophen), paracetamol
Intervention Description
Acetaminophen, 10mg/kg
Primary Outcome Measure Information:
Title
Fever Reduction
Description
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
Secondary Outcome Measure Information:
Title
Change From Baseline in Temperature After the First 30 Minutes of Treatment
Description
Change in temperature in patients receiving intravenous ibuprofen and acetaminophen (APAP) after the first 30 minutes of treatment.
Time Frame
30 minutes following treatment
Title
Change From Baseline in Temperature After the First 60 Minutes of Treatment
Description
Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 60 minutes of treatment.
Time Frame
60 minutes following treatment
Title
Change in Temperature
Description
Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 4 hours of treatment.
Time Frame
4 hours following treatment
Title
Change From Baseline in Temperature After the First Four Hours of Treatment
Description
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)
Time Frame
0 to 4 hours post-dose
Title
Time to Afebrility (in Hours)
Description
Tme to afebrility (temperature less than 100.4 ºF [38 ºC]) in patients receiving intravenous ibuprofen and APAP.
Time Frame
4 Hour post treatment
Title
Number of Afebrile and Febrile Subject at 4 Hours Post-Dose
Description
Number of Afebrile and Febrile Subject at 4 Hours Following Treatment
Time Frame
4 Hours Post-Dose

10. Eligibility

Sex
All
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Art Wheeler, M.D.
Organizational Affiliation
Cumberland Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Maricopa Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Howard University
City
Washington DC
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Jackson Memorial Hospital (U. Miami)
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Joseph M. Still Burn Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121-2483
Country
United States
Facility Name
LSU Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
The Children's Hospital at Saint Francis
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
LeBonheur Children's Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Children's Medical Center Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Children's Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28143430
Citation
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.
Results Reference
derived

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

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