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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Upper Respiratory Tract Infections
• Intervention / Treatment: Drug: diclofenac potassium; Drug: nimesulide

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction of fever as measured by axillary temperature	120 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Reduction of pain as measured by visual analog scale	120 minutes

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: December 8, 2010
• First Submitted That Met QC Criteria: December 8, 2010
• First Posted (Estimate): December 9, 2010

Study Record Updates

• Last Update Posted (Estimate): April 26, 2012
• Last Update Submitted That Met QC Criteria: April 25, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: pain; fever; Upper respiratory tract infections; diclofenac potassium; nimesulide
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac; Nimesulide
• Other Study ID Numbers: CCAT458CMX01