MedDataX Logo

Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

NCT ID: NCT02583399

Last Updated: 2020-11-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-08

Study Completion Date

2019-07-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Fever

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Pediatric (Birth to less than 6 months of age) Pain Fever

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Multi-center, Open-label
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ibuprofen

Ibuprofen, 10 mg/kg

Group Type EXPERIMENTAL

Ibuprofen

Intervention Type DRUG

Ibuprofen, 10 mg/kg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ibuprofen

Ibuprofen, 10 mg/kg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cumberland Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Todd Rice, MD

Role: STUDY_CHAIR

Vanderbilt University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kosair Charaties Pediatric Research Unit

Louisville, Kentucky, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Children's Medical Center Dallas

Dallas, Texas, United States

Site Status

Baylor College of Medicine/Texas Children's Hospital

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Glover CD, Berkenbosch JW, Taylor MB, Patel NV, Kaelin B, Gibson BHY, Zhong J. A Multi-Center Evaluation of the Pharmacokinetics and Safety of Intravenous Ibuprofen in Infants 1-6 Months of Age. Paediatr Drugs. 2023 Sep;25(5):585-593. doi: 10.1007/s40272-023-00576-9. Epub 2023 Jun 9.

Reference Type DERIVED
PMID: 37294477 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CPI-CL-022

Identifier Type: -

Identifier Source: org_study_id