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

Primary Purpose

Fever

Status
Terminated
Phase
Phase 4
Locations
Venezuela
Study Type
Interventional
Intervention
Diclofenac potassium
Acetaminophen
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fever focused on measuring Antipyretics, fever, diclofenac, acetaminophen, children, acute upper respiratory tract infections

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Hospital de niños "J. M. de los Rios", Distrito Metropolitano
  • Ciudad Hospitalaria Enrique Tejera, Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Diclofenac potassium

Acetaminophen

Arm Description

Outcomes

Primary Outcome Measures

The Reduction of Temperature

Secondary Outcome Measures

Time to Reach a Reduction of Temperature as 0.5 and 1 °C
Time With a Temperature ≤ 38,4 °C in a Period of 6 Hours
Safety of Diclofenac Potassium Therapy in the Study Period
The Level of Knowledge That Parents or Legal Representatives Have on the Treatment of Fever

Full Information

First Posted
November 20, 2009
Last Updated
October 18, 2012
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01019980
Brief Title
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

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
Placebo - Active Drug Not Available. No patients received drug. There are no study results to disclose.
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever
Keywords
Antipyretics, fever, diclofenac, acetaminophen, children, acute upper respiratory tract infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diclofenac potassium
Arm Type
Experimental
Arm Title
Acetaminophen
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Diclofenac potassium
Intervention Description
Diclofenac potassium
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
Acetaminophen
Primary Outcome Measure Information:
Title
The Reduction of Temperature
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Time to Reach a Reduction of Temperature as 0.5 and 1 °C
Time Frame
2 hours
Title
Time With a Temperature ≤ 38,4 °C in a Period of 6 Hours
Time Frame
6 hours
Title
Safety of Diclofenac Potassium Therapy in the Study Period
Time Frame
6 hours
Title
The Level of Knowledge That Parents or Legal Representatives Have on the Treatment of Fever
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de niños "J. M. de los Rios", Distrito Metropolitano
City
Caracas
Country
Venezuela
Facility Name
Ciudad Hospitalaria Enrique Tejera, Valencia
City
Estado Carabobo
Country
Venezuela

12. IPD Sharing Statement

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

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