Efficacy of Diclofenac Potassium vs Nimesulide in the Treatment of Fever and Pain in Children With Upper Respiratory Tract Infection
Phase 4
Withdrawn
- Conditions
- Upper Respiratory Tract Infections
- Interventions
- Registration Number
- NCT01257126
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description diclofenac potassium diclofenac potassium - nimesulide nimesulide -
- Primary Outcome Measures
Name Time Method Reduction of fever as measured by axillary temperature 120 minutes
- Secondary Outcome Measures
Name Time Method Reduction of pain as measured by visual analog scale 120 minutes