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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

November 20, 2009
October 18, 2012
March 2010
March 2010   (final data collection date for primary outcome measure)
The Reduction of Temperature [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01019980 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy of Diclofenac Potassium Versus Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections
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 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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Fever
  • Drug: Diclofenac potassium
    Diclofenac potassium
  • Drug: Acetaminophen
    Acetaminophen
  • Experimental: Diclofenac potassium
    Intervention: Drug: Diclofenac potassium
  • Active Comparator: Acetaminophen
    Intervention: Drug: Acetaminophen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
Not Provided
March 2010   (final data collection date for primary outcome measure)

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

Both
2 Years to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
Venezuela
 
NCT01019980
CVOL458AVE02
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP