Efficacy of Diclofenac Potassium vs Nimesulide in the Treatment of Fever and Pain in Children With Upper Respiratory Tract Infection

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
First received: December 8, 2010
Last updated: April 25, 2012
Last verified: April 2012
This is a local, phase IV, open-label, randomized, head to head study of children aged 3 to 7 years. The objective of the study is to compare the efficacy of a single dose of both diclofenac potassium and nimesulide in the reduction of fever and pain secondary to upper respiratory tract infection.

Condition Intervention Phase
Upper Respiratory Tract Infections
Drug: diclofenac potassium
Drug: nimesulide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Diclofenac Potassium Versus Nimesulide in the Treatment of Fever and Pain in Children Aged 3 to 7 Years With Community Acquired, Non-complicated, Upper Respiratory Tract Infection

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Reduction of fever as measured by axillary temperature [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction of pain as measured by visual analog scale [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: April 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: diclofenac potassium Drug: diclofenac potassium
Active Comparator: nimesulide Drug: nimesulide


Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children who present community acquired, non-complicated, upper respiratory tract infection: rhino-sinusitis, pharyngitis, tonsillitis, ear infection or the combination of these.
  • Child must present axillary temperature ≥ 37.5°C.

Exclusion Criteria:

  • Prior history of allergic reaction to the components of the study medication.
  • Use of any NSAID or pharmacologic agent in the 24 hours prior to visit 1.
  • Subjects who, in the opinion of the investigator, have developed, or are at risk of developing, a complicated infection and are not suitable subjects for the purposes of the study.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01257126

Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01257126     History of Changes
Other Study ID Numbers: CCAT458CMX01 
Study First Received: December 8, 2010
Last Updated: April 25, 2012
Health Authority: Mexico: Ministry of Health

Keywords provided by Novartis:
Upper respiratory tract infections
diclofenac potassium

Additional relevant MeSH terms:
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on May 25, 2016