Efficacy of Diclofenac Potassium Versus Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections

This study has been terminated.
(Placebo - Active Drug Not Available. No patients received drug. There are no study results to disclose.)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01019980
First received: November 20, 2009
Last updated: October 18, 2012
Last verified: October 2012
Results First Received: March 15, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Fever
Interventions: Drug: Diclofenac potassium
Drug: Acetaminophen

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
2 participants entered the study but did not receive drug because drug was not available in the region. The study was then terminated.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Diclofenac Potassium This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
Acetaminophen This study was cancelled. No patients were enrolled in this group.

Participant Flow:   Overall Study
    Diclofenac Potassium     Acetaminophen  
STARTED     2 [1]   0  
Discontinued     2     0  
COMPLETED     0     0  
NOT COMPLETED     2     0  
Drug not available.                 2                 0  
[1] 2 patients entered study but did not receive any drug since it was not available in the region.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Diclofenac Potassium This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
Acetaminophen This study was cancelled. No patients were enrolled in this group.
Total Total of all reporting groups

Baseline Measures
    Diclofenac Potassium     Acetaminophen     Total  
Number of Participants  
[units: participants]
  0     0     0  
Age [1]
[units: years]
Mean ± Standard Deviation
           
Gender  
[units: participants]
     
Female              
Male              
Region of Enrollment  
[units: participants]
     
Venezuela              
[1] This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region



  Outcome Measures

1.  Primary:   The Reduction of Temperature   [ Time Frame: 2 hours ]

2.  Secondary:   Time to Reach a Reduction of Temperature as 0.5 and 1 °C   [ Time Frame: 2 hours ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Time With a Temperature ≤ 38,4 °C in a Period of 6 Hours   [ Time Frame: 6 hours ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Safety of Diclofenac Potassium Therapy in the Study Period   [ Time Frame: 6 hours ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   The Level of Knowledge That Parents or Legal Representatives Have on the Treatment of Fever   [ Time Frame: 2 hours ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region.  


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01019980     History of Changes
Other Study ID Numbers: CVOL458AVE02
Study First Received: November 20, 2009
Results First Received: March 15, 2012
Last Updated: October 18, 2012
Health Authority: Venezuela: Rafael Rangel Institute