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

Phase 4

Terminated

• Conditions: Fever
• Interventions: Drug: Diclofenac potassium; Drug: Acetaminophen

• Registration Number: NCT01019980
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-20
• Study First Submitted QC: 2009-11-24
• Study First Posted: 2009-11-25
• Study Start: 2010-03
• Primary Completion: 2010-03
• Results First Submitted: 2012-03-15
• Status Verified: 2012-10
• Results First Submitted QC: 2012-10-18
• Last Update Submitted: 2012-10-18
• Results First Posted: 2012-11-19
• Last Update Posted: 2012-11-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diclofenac potassium	Diclofenac potassium	-
Acetaminophen	Acetaminophen	-

Primary Outcome Measures

Name	Time	Method
The Reduction of Temperature	2 hours

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Ciudad Hospitalaria Enrique Tejera, Valencia; 🇻🇪 Estado Carabobo, Venezuela

Hospital de niños "J. M. de los Rios", Distrito Metropolitano; 🇻🇪 Caracas, Venezuela