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

Upper Respiratory Tract Infections Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01257126
• Other study ID #: CCAT458CMX01
• Status: Withdrawn
• Phase: Phase 4
• First received: December 8, 2010
• Last updated: April 25, 2012
• Start date: April 2011

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 7 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Tract Infections
• Upper Respiratory Tract Infections

Intervention

Drug:
• diclofenac potassium

• nimesulide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of fever as measured by axillary temperature		120 minutes	No
Secondary	Reduction of pain as measured by visual analog scale		120 minutes	No