Efficacy of Diclofenac Potassium Versus Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections

October 18, 2012 updated by: Novartis Pharmaceuticals

A Comparative Double Blind, Double Dummy, Randomized Study on the Effectiveness of Diclofenac Potassium vs. Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections

The purpose of this study is to assess if a single dose of Diclofenac potassium (0.5 mg/kg) is more or as effective as a single dose of Acetaminophen (10 mg/kg) in the reduction of fever during 2 hours, in the treatment of febrile children with acute upper respiratory infections.

This is a comparative double blind, double dummy, randomized study on the effectiveness of Diclofenac potassium versus Acetaminophen in febrile children with acute upper respiratory tract infections. The patient will be randomized to either group: Group A (Diclofenac potassium (0.5 mg/kg) or Group B (Acetaminophen (10 mg/kg)). A Health Care Professional trained will measure the temperature during 2 hours. During the study period, parents or legal representatives will be invited to fill a survey about the habits and knowledge regarding fever management at home.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Venezuela
      • Caracas, Venezuela
        • Hospital de niños "J. M. de los Rios", Distrito Metropolitano
      • Estado Carabobo, Venezuela
        • Ciudad Hospitalaria Enrique Tejera, Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female outpatients, aged 2 to 6 years presenting tympanic temperature ≥ 38.5 ° C and no greater than 39.5° C, associated with acute upper respiratory tract infections
  • Parents or legal representatives who have provided written informed consent and provided a phone number for the call at end of study

Exclusion Criteria:

  • History of hypersensitivity to any drugs or excipients of the study
  • Any medication, surgical, or medical condition, which might significantly alter the absorption, distribution, metabolism, or excretion of medications
  • Background or suspected hematological disorders, febrile seizures, asthma, peptic ulcer or gastrointestinal bleeding
  • Neurological and hemodynamics disorders
  • Evidence of liver or kidney impairment or heart failure
  • Patients who have received previous treatment with antipyretics; acetaminophen (up to 4 hrs), NSAIDs (up to 6 hrs) or antibiotic therapy (at least 12 hours)
  • Any surgical or medical condition, which in the opinion of the investigator, may place the patient at risk

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acetaminophen
Drug: Acetaminophen
Acetaminophen
Experimental: Diclofenac potassium
Drug: Diclofenac potassium
Diclofenac potassium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Reduction of Temperature
Time Frame: 2 hours
2 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Reach a Reduction of Temperature as 0.5 and 1 °C
Time Frame: 2 hours
2 hours
Time With a Temperature ≤ 38,4 °C in a Period of 6 Hours
Time Frame: 6 hours
6 hours
Safety of Diclofenac Potassium Therapy in the Study Period
Time Frame: 6 hours
6 hours
The Level of Knowledge That Parents or Legal Representatives Have on the Treatment of Fever
Time Frame: 2 hours
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

November 20, 2009

First Submitted That Met QC Criteria

November 24, 2009

First Posted (Estimate)

November 25, 2009

Study Record Updates

Last Update Posted (Estimate)

November 19, 2012

Last Update Submitted That Met QC Criteria

October 18, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVOL458AVE02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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