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

This study has been terminated.
(Placebo - Active Drug Not Available. No patients received drug. There are no study results to disclose.)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01019980
First received: November 20, 2009
Last updated: October 18, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Fever
 Drug: Diclofenac potassium
Drug: Acetaminophen
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • The Reduction of Temperature [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Reach a Reduction of Temperature as 0.5 and 1 °C [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Time With a Temperature ≤ 38,4 °C in a Period of 6 Hours [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Safety of Diclofenac Potassium Therapy in the Study Period [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • The Level of Knowledge That Parents or Legal Representatives Have on the Treatment of Fever [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diclofenac potassium Drug: Diclofenac potassium
Diclofenac potassium
Active Comparator: Acetaminophen Drug: Acetaminophen
Acetaminophen

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01019980

Locations
Venezuela
Hospital de niños "J. M. de los Rios", Distrito Metropolitano
Caracas, Venezuela
Ciudad Hospitalaria Enrique Tejera, Valencia
Estado Carabobo, Venezuela
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01019980     History of Changes
Other Study ID Numbers: CVOL458AVE02
Study First Received: November 20, 2009
Results First Received: March 15, 2012
Last Updated: October 18, 2012
Health Authority: Venezuela: Rafael Rangel Institute

Keywords provided by Novartis:
Antipyretics
fever
diclofenac
 acetaminophen
children
acute upper respiratory tract infections

Additional relevant MeSH terms:
Fever
Respiratory Tract Infections
Common Cold
Body Temperature Changes
Signs and Symptoms
Infection
Respiratory Tract Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Acetaminophen
Diclofenac
Antipyretics
Physiological Effects of Drugs
 Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013