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Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02583399
Recruitment Status : Completed
First Posted : October 22, 2015
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Fever Drug: Ibuprofen Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Multi-center, Open-label
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 17, 2017
Actual Primary Completion Date : July 2, 2019
Actual Study Completion Date : July 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Experimental: Ibuprofen
Ibuprofen, 10 mg/kg
Drug: Ibuprofen
Ibuprofen, 10 mg/kg




Primary Outcome Measures :
  1. To evaluate the pharmacokinetic profile (Maximum Plasma Concentration [Cmax]) of a single dose of IVIb administered over 5-7 minutes. [ Time Frame: 4 hours ]

Secondary Outcome Measures :
  1. To evaluate the pharmacokinetic profile (Elimination Half Life [T 1/2]) of a single dose of IVIb administered over 5-7 minutes. [ Time Frame: 4 hours ]
  2. To evaluate the safety of single dose of intravenous ibuprofen by assessing treatment emergent adverse events [ Time Frame: 72 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02583399


Locations
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United States, Kentucky
Kosair Charaties Pediatric Research Unit
Louisville, Kentucky, United States, 40202
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Texas
Children's Medical Center Dallas
Dallas, Texas, United States, 75235
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Cumberland Pharmaceuticals
Investigators
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Study Chair: Todd Rice, MD Vanderbilt University

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Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02583399     History of Changes
Other Study ID Numbers: CPI-CL-022
First Posted: October 22, 2015    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cumberland Pharmaceuticals:
Pediatric (Birth to less than 6 months of age)
Pain
Fever
Additional relevant MeSH terms:
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Ibuprofen
Fever
Body Temperature Changes
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action