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A Study of Caldolor in Hospitalized Febrile Pediatric Patients

NCT00225706 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2010-04-12

No results posted yet for this study

Summary

The primary objective of this study of Caldolor administered to febrile hospitalized pediatric patients every 6 hours for 24 hours is to determine the clinical equivalence of a single dose of Caldolor compared to acetaminophen (paracetamol; APAP) for the treatment of fever as measured by the AUC Tº within the first 6 hours of treatment (as compared to a target temperature of 98.6ºF \[37.0ºC\]).

Conditions

Interventions

DRUG

Caldolor

Sponsors & Collaborators

  • Cumberland Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • United States
  • Panama
  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00225706 on ClinicalTrials.gov