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

NCT ID: NCT01019980

Last Updated: 2012-11-19

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Brief Summary

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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

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Conditions

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Fever

Keywords

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Antipyretics fever diclofenac acetaminophen children acute upper respiratory tract infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Diclofenac potassium

Group Type EXPERIMENTAL

Diclofenac potassium

Intervention Type DRUG

Diclofenac potassium

Acetaminophen

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

Acetaminophen

Interventions

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Diclofenac potassium

Diclofenac potassium

Intervention Type DRUG

Acetaminophen

Acetaminophen

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Hospital de niños "J. M. de los Rios", Distrito Metropolitano

Caracas, , Venezuela

Site Status

Ciudad Hospitalaria Enrique Tejera, Valencia

Estado Carabobo, , Venezuela

Site Status

Countries

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Venezuela

Other Identifiers

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CVOL458AVE02

Identifier Type: -

Identifier Source: org_study_id