Clinical trial NCT01019980: Efficacy of Diclofenac Potassium Versus Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Fever
Keywords: Antipyretics
fever
diclofenac
acetaminophen
children
acute upper respiratory tract infections
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-11-25
Enrollment: 2
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The Reduction of Temperature
timeFrame: 2 hours
Secondary outcomes:
measure: Time to Reach a Reduction of Temperature as 0.5 and 1 °C
timeFrame: 2 hours
measure: Time With a Temperature ≤ 38,4 °C in a Period of 6 Hours
timeFrame: 6 hours
measure: Safety of Diclofenac Potassium Therapy in the Study Period
timeFrame: 6 hours
measure: The Level of Knowledge That Parents or Legal Representatives Have on the Treatment of Fever
timeFrame: 2 hours
Other outcomes:
Locations:
city: Caracas
country: Venezuela
facility: Hospital de niños "J. M. de los Rios", Distrito Metropolitano
city: Estado Carabobo
country: Venezuela
facility: Ciudad Hospitalaria Enrique Tejera, Valencia
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: