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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Upper Respiratory Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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diclofenac potassium

Group Type EXPERIMENTAL

diclofenac potassium

Intervention Type DRUG

nimesulide

Group Type ACTIVE_COMPARATOR

nimesulide

Intervention Type DRUG

Interventions

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diclofenac potassium

Intervention Type DRUG

nimesulide

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No