Efficacy of Diclofenac Potassium vs Nimesulide in the Treatment of Fever and Pain in Children With Upper Respiratory Tract Infection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01257126|
Recruitment Status : Withdrawn
First Posted : December 9, 2010
Last Update Posted : April 26, 2012
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Upper Respiratory Tract Infections||Drug: diclofenac potassium Drug: nimesulide||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||April 2011|
|Estimated Primary Completion Date :||December 2011|
|Experimental: diclofenac potassium||
Drug: diclofenac potassium
|Active Comparator: nimesulide||
- Reduction of fever as measured by axillary temperature [ Time Frame: 120 minutes ]
- Reduction of pain as measured by visual analog scale [ Time Frame: 120 minutes ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||3 Years to 7 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01257126
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|
|Responsible Party:||Novartis Pharmaceuticals|
|Other Study ID Numbers:||
|First Posted:||December 9, 2010 Key Record Dates|
|Last Update Posted:||April 26, 2012|
|Last Verified:||April 2012|
Upper respiratory tract infections
Respiratory Tract Infections
Respiratory Tract Diseases
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action