Upper Respiratory Tract Infections
Conditions
Keywords
Upper respiratory tract infections, diclofenac potassium, nimesulide, fever, pain
Brief 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.
Interventions
DRUGnimesulide
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 7 Years
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of fever as measured by axillary temperature | 120 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of pain as measured by visual analog scale | 120 minutes |
Outcome results
None listed