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

Novartis

Status and phase

Withdrawn

Phase 4

Conditions

Upper Respiratory Tract Infections

Treatments

Drug: diclofenac potassium

Drug: nimesulide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01257126

CCAT458CMX01

Details and patient eligibility

About

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.

Sex

All

Ages

3 to 7 years old

Volunteers

No Healthy Volunteers

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