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

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ClinicalTrials.gov Identifier: NCT01019980
Recruitment Status : Terminated (Placebo - Active Drug Not Available. No patients received drug. There are no study results to disclose.)
First Posted : November 25, 2009
Results First Posted : November 19, 2012
Last Update Posted : November 19, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Fever
Interventions Drug: Diclofenac potassium
Drug: Acetaminophen
Enrollment 2
Recruitment Details 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  
Arm/Group Title Diclofenac Potassium Acetaminophen
Hide Arm/Group Description This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region This study was cancelled. No patients were enrolled in this group.
Period Title: Overall Study
Started 2 [1] 0
Discontinued 2 0
Completed 0 0
Not Completed 2 0
Reason Not Completed
Drug not available.             2             0
[1]
2 patients entered study but did not receive any drug since it was not available in the region.
Arm/Group Title Diclofenac Potassium Acetaminophen Total
Hide Arm/Group Description This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region This study was cancelled. No patients were enrolled in this group. Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 0 participants 0 participants 0 participants
[1]
Measure Description: This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Venezuela Number Analyzed 0 participants 0 participants 0 participants
1.Primary Outcome
Title The Reduction of Temperature
Hide Description [Not Specified]
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diclofenac Potassium Acetaminophen
Hide Arm/Group Description:
This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
This study was cancelled. No patients were enrolled in this group.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Time to Reach a Reduction of Temperature as 0.5 and 1 °C
Hide Description [Not Specified]
Time Frame 2 hours
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Time With a Temperature ≤ 38,4 °C in a Period of 6 Hours
Hide Description [Not Specified]
Time Frame 6 hours
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Safety of Diclofenac Potassium Therapy in the Study Period
Hide Description [Not Specified]
Time Frame 6 hours
Outcome Measure Data Not Reported
5.Secondary Outcome
Title The Level of Knowledge That Parents or Legal Representatives Have on the Treatment of Fever
Hide Description [Not Specified]
Time Frame 2 hours
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diclofenac Potassium Acetaminophen
Hide Arm/Group Description This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region This study was cancelled. No patients were enrolled in this group.
All-Cause Mortality
Diclofenac Potassium Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Diclofenac Potassium Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Diclofenac Potassium Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region.
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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01019980     History of Changes
Other Study ID Numbers: CVOL458AVE02
First Submitted: November 20, 2009
First Posted: November 25, 2009
Results First Submitted: March 15, 2012
Results First Posted: November 19, 2012
Last Update Posted: November 19, 2012