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Trial record 28 of 249 for:    Recruiting, Not yet recruiting, Available Studies | "Fever"

Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT02583399
Recruitment Status : Recruiting
First Posted : October 22, 2015
Last Update Posted : January 9, 2018
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 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
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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


Contacts
Contact: Byron Kaelin 615-255-0068 ext 250 bkaelin@cumberlandpharma.com
Contact: Jerry Fox 615-255-0068 ext 226 jfox@cumberlandpharma.com

Locations
United States, Kentucky
Kosair Charaties Pediatric Research Unit Recruiting
Louisville, Kentucky, United States, 40202
Contact: John W Berkenbosch, MD         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Dana Lindsay, BSN    601-815-9480      
Principal Investigator: Mary Taylor, MD         
United States, Texas
Children's Medical Center Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: John Zhong, MD         
Contact: Roxana Polaski, RN    (214) 456-8559      
Baylor College of Medicine/Texas Children's Hospital Not yet recruiting
Houston, Texas, United States, 77030
Contact: Chris Glover, MD         
Contact: Margaret Owens-Stuberfield         
Sponsors and Collaborators
Cumberland Pharmaceuticals
Investigators
Study Chair: Todd Rice, MD Vanderbilt University

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: January 9, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Fever
Body Temperature Changes
Signs and Symptoms
Ibuprofen
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