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”

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 vs. 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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment

Study Primary Completion Date: June 2010

Intervention(s) in this Clinical Trial

• Drug: Diclofenac potassium
  • Diclofenac potassium
• Drug: Acetaminophen
  • Acetaminophen

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Diclofenac potassium
• Active Comparator: Acetaminophen

Primary Measures

• The reduction of temperature
  • Time Frame: 2 hours
    Safety Issue?: No

Secondary Measures

• Time to reach a reduction of temperature as 0.5 and 1 °C
  • Time Frame: 2 hours
    Safety Issue?: No
• Time with a temperature ≤ 38,4 °C in a period of 6 hours
  • Time Frame: 6 hours
    Safety Issue?: No
• Safety of Diclofenac potassium therapy in the study period
  • Time Frame: 6 hours
    Safety Issue?: No
• The level of knowledge that parents or legal representatives have on the treatment of fever
  • Time Frame: 2 hours
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 6 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Overall Contact: Novartis Pharmaceuticals +41-61-324-1111 

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01019980

Study ID Number: CVOL458AVE02

ClinicalTrials.gov Identifier: NCT01019980

Health Authority: Venezuela: Rafael Rangel Institute