CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Ibuprofendrug
Likely dose
Ibuprofen 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02583399
NCT02583399Phase 4Completed
CompareCT.gov

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

Cumberland Pharmaceuticals·interventional·Posted Oct 22, 2015·Updated Nov 20, 2020

In Brief

A Phase 4 clinical trial evaluating Ibuprofen for Pain and Fever. Completed, enrolled 30 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Fever
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 22, 2015
Enrollment StartAug 8, 2017
Primary CompletionJul 2, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.7 years ago

Interventions

Ibuprofendrug

Ibuprofen, 10 mg/kg