Efficacy of Diclofenac Potassium vs Nimesulide in the Treatment of Fever and Pain in Children With Upper Respiratory Tract Infection
Information source: Novartis
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Upper Respiratory Tract Infections
Intervention: diclofenac potassium (Drug); nimesulide (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Overall contact:
Novartis Pharmaceuticals, Phone: + 41 61 324 1111
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Reduction of fever as measured by axillary temperature
Secondary outcome: Reduction of pain as measured by visual analog scale
Eligibility
Minimum age: 3 Years.
Maximum age: 7 Years.
Gender(s): Both.
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
Locations and Contacts
Novartis Pharmaceuticals, Phone: + 41 61 324 1111
Centro de Investigación Farmacológica y Biotecnológica (CIF-BIOTEC) de Médica Sur, México DF 14050, Mexico
Unidad de Investigación de Médica Sur del Hospital General "Dr. Fernando Quiroz Gutierrez", Valle de Chalco, Mexico
Additional Information
Starting date: April 2011
Last updated: December 8, 2010
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