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

Novartis

Status and phase

Terminated

Phase 4

Conditions

Fever

Treatments

Drug: Diclofenac potassium

Drug: Acetaminophen

Study type

Interventional

Funder types

Industry

Identifiers

NCT01019980

CVOL458AVE02

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

2 to 6 years old

Volunteers

No Healthy Volunteers

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