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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This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01257126
First received: December 8, 2010
Last updated: April 25, 2012
Last verified: April 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

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

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

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: 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
nimesulide
fever
pain

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

ClinicalTrials.gov processed this record on May 19, 2013