Safety of Aerius Syrup in Pediatric Patients Aged 1-5 Years Old With Allergic Rhinitis or Chronic Idiopathic Urticaria (Study P04446AM1)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00723736
First received: July 25, 2008
Last updated: May 27, 2010
Last verified: May 2010
Results First Received: June 18, 2009  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Rhinitis
Urticaria
Intervention: Drug: Desloratadine

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Aerius® Syrup Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria

Participant Flow:   Overall Study
    Aerius® Syrup  
STARTED     100  
COMPLETED     99 [1]
NOT COMPLETED     1  
[1] Subject's caregiver did not wish to continue, reasons unrelated.



  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.
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Reporting Groups
  Description
Aerius® Syrup Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria

Baseline Measures
    Aerius® Syrup  
Number of Participants  
[units: participants]
  100  
Age  
[units: years]
Mean ± Standard Deviation
  3.1  ± 1.2  
Gender  
[units: participants]
 
Female     45  
Male     55  



  Outcome Measures

1.  Primary:   Proportion of Patients With Adverse Events   [ Time Frame: Follow-up visit at 3 - 5 weeks after treatment initiation ]


  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
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Results Point of Contact:  
Name/Title: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com


No publications provided


Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00723736     History of Changes
Other Study ID Numbers: P04446
Study First Received: July 25, 2008
Results First Received: June 18, 2009
Last Updated: May 27, 2010
Health Authority: Hungary: National Institute of Pharmacy