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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01019980
Recruitment Status : Terminated (Placebo - Active Drug Not Available. No patients received drug. There are no study results to disclose.)
First Posted : November 25, 2009
Results First Posted : November 19, 2012
Last Update Posted : November 19, 2012
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

November 20, 2009
November 25, 2009
March 15, 2012
November 19, 2012
November 19, 2012
March 2010
March 2010   (Final data collection date for primary outcome measure)
The Reduction of Temperature [ Time Frame: 2 hours ]
Same as current
Complete list of historical versions of study NCT01019980 on Archive Site
  • Time to Reach a Reduction of Temperature as 0.5 and 1 °C [ Time Frame: 2 hours ]
  • Time With a Temperature ≤ 38,4 °C in a Period of 6 Hours [ Time Frame: 6 hours ]
  • Safety of Diclofenac Potassium Therapy in the Study Period [ Time Frame: 6 hours ]
  • The Level of Knowledge That Parents or Legal Representatives Have on the Treatment of Fever [ Time Frame: 2 hours ]
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
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Drug: Diclofenac potassium
    Diclofenac potassium
  • Drug: 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 Identifier (NCT Number) in Medline.
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

Sexes Eligible for Study: All
2 Years to 6 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
October 2012

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