Status:
WITHDRAWN
Efficacy of Diclofenac Potassium vs Nimesulide in the Treatment of Fever and Pain in Children With Upper Respiratory Tract Infection
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Upper Respiratory Tract Infections
Eligibility:
All Genders
3-7 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01257126
Start Date
April 1 2011
Last Update
April 26 2012
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