Back to resultsEfficacy of Diclofenac Potassium vs Nimesulide in the Treatment of Fever and Pain in Children With Upper Respiratory Tract Infection
Primary Purpose
Upper Respiratory Tract Infections
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
diclofenac potassium
nimesulide
Sponsored by
About this trial
This is an interventional treatment trial for Upper Respiratory Tract Infections focused on measuring Upper respiratory tract infections, diclofenac potassium, nimesulide, fever, pain
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
diclofenac potassium
nimesulide
Arm Description
Outcomes
Primary Outcome Measures
Reduction of fever as measured by axillary temperature
Secondary Outcome Measures
Reduction of pain as measured by visual analog scale
Full Information
NCT ID
NCT01257126
First Posted
December 8, 2010
Last Updated
April 25, 2012
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01257126
Brief Title
Efficacy of Diclofenac Potassium vs Nimesulide in the Treatment of Fever and Pain in Children With Upper Respiratory Tract Infection
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Withdrawn
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infections
Keywords
Upper respiratory tract infections, diclofenac potassium, nimesulide, fever, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
diclofenac potassium
Arm Type
Experimental
Arm Title
nimesulide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
diclofenac potassium
Intervention Type
Drug
Intervention Name(s)
nimesulide
Primary Outcome Measure Information:
Title
Reduction of fever as measured by axillary temperature
Time Frame
120 minutes
Secondary Outcome Measure Information:
Title
Reduction of pain as measured by visual analog scale
Time Frame
120 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Diclofenac Potassium vs Nimesulide in the Treatment of Fever and Pain in Children With Upper Respiratory Tract Infection
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