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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01257126

Collaborator

(none)

Enrollment

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Upper Respiratory Tract Infections	Drug: diclofenac potassium Drug: nimesulide	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Apr 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: diclofenac potassium	Drug: diclofenac potassium
Active Comparator: nimesulide	Drug: nimesulide

Arm

Intervention/Treatment

Experimental: diclofenac potassium

Drug: diclofenac potassium

Active Comparator: nimesulide

Drug: nimesulide

Outcome Measures

Primary Outcome Measures

Reduction of fever as measured by axillary temperature [120 minutes]

Secondary Outcome Measures

Reduction of pain as measured by visual analog scale [120 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 7 Years

Sexes Eligible for Study:

All

Accepts 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