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

Fever Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01019980
• Other study ID #: CVOL458AVE02
• Status: Terminated
• Phase: Phase 4
• First received: November 20, 2009
• Last updated: October 18, 2012
• Start date: March 2010

Study information

• Verified date: October 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Venezuela: Rafael Rangel Institute
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 6 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fever
• Respiratory Tract Infections

Intervention

Drug:
• Diclofenac potassium
Diclofenac potassium
• Acetaminophen
Acetaminophen

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Reduction of Temperature		2 hours	No
Secondary	Time to Reach a Reduction of Temperature as 0.5 and 1 °C		2 hours	No
Secondary	Time With a Temperature = 38,4 °C in a Period of 6 Hours		6 hours	No
Secondary	Safety of Diclofenac Potassium Therapy in the Study Period		6 hours	No
Secondary	The Level of Knowledge That Parents or Legal Representatives Have on the Treatment of Fever		2 hours	No