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This study has been withdrawn prior to enrollment.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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Infection
Respiratory Tract 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 August 20, 2014