Observation of Side Effects and Effectiveness of Desloratadine (Aerius) Syrup in Filipino Children (Study P05634)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00761527
First received: September 25, 2008
Last updated: August 19, 2014
Last verified: August 2014
Results First Received: November 4, 2011  
Study Type: Observational
Study Design: Observational Model: Ecologic or Community;   Time Perspective: Prospective
Conditions: Rhinitis, Allergic, Seasonal
Rhinitis, Allergic, Perennial
Urticaria
Intervention: Drug: Desloratadine Syrup

  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
The total number of participants enrolled was 2980. A total of 2978 participants received at least one dose of study medication.

Reporting Groups
  Description
Desloratadine (Aerius) Syrup

Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:

  • Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)
  • Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)
  • Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)

Participant Flow:   Overall Study
    Desloratadine (Aerius) Syrup  
STARTED     2980  
Received One Dose of Study Medication     2978  
COMPLETED     2958  
NOT COMPLETED     22  
Adverse Event                 3  
Poor Compliance                 8  
Lost to Follow-up                 9  
Unknown reason                 2  



  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
Desloratadine (Aerius) Syrup

Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:

  • Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)
  • Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)
  • Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)

Baseline Measures
    Desloratadine (Aerius) Syrup  
Number of Participants  
[units: participants]
  2978  
Age  
[units: years]
Mean ± Standard Deviation
  5.74  ± 3.272  
Gender, Customized [1]
[units: Participants]
 
Male     1511  
Female     1457  
Missing Data     10  
[1] Number of participants with non-missing data for the relevant variable in the safety population (N= 2968) which included all participants who had taken at least one dose of study medication.



  Outcome Measures
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1.  Primary:   Number of Adverse Events Reported By Category After 14 Days of Treatment   [ Time Frame: 15 Days ]

2.  Primary:   Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment   [ Time Frame: 15 Days ]

3.  Primary:   Participant Global Tolerability Assessment   [ Time Frame: Day 15 ]

4.  Secondary:   Investigator Assessment of Clinical Efficacy   [ Time Frame: Day 15 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00761527     History of Changes
Other Study ID Numbers: P05634
Study First Received: September 25, 2008
Results First Received: November 4, 2011
Last Updated: August 19, 2014
Health Authority: Philippines: Bureau of Food and Drugs