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

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ClinicalTrials.gov 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 )

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.

Condition or disease Intervention/treatment Phase
Fever Drug: Diclofenac potassium Drug: Acetaminophen Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : March 2010
Actual Primary Completion Date : March 2010

Arm Intervention/treatment
Experimental: Diclofenac potassium Drug: Diclofenac potassium
Diclofenac potassium

Active Comparator: Acetaminophen Drug: Acetaminophen

Primary Outcome Measures :
  1. The Reduction of Temperature [ Time Frame: 2 hours ]

Secondary Outcome Measures :
  1. Time to Reach a Reduction of Temperature as 0.5 and 1 °C [ Time Frame: 2 hours ]
  2. Time With a Temperature ≤ 38,4 °C in a Period of 6 Hours [ Time Frame: 6 hours ]
  3. Safety of Diclofenac Potassium Therapy in the Study Period [ Time Frame: 6 hours ]
  4. The Level of Knowledge That Parents or Legal Representatives Have on the Treatment of Fever [ Time Frame: 2 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01019980

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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
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01019980    
Other Study ID Numbers: CVOL458AVE02
First Posted: November 25, 2009    Key Record Dates
Results First Posted: November 19, 2012
Last Update Posted: November 19, 2012
Last Verified: October 2012
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
acute upper respiratory tract infections
Additional relevant MeSH terms:
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Respiratory Tract Infections
Respiratory Tract Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action