Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00761527
First received: September 25, 2008
Last updated: January 27, 2012
Last verified: January 2012
History of Changes
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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
  Hide Baseline Characteristics

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
  Show All Outcome Measures

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

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

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

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


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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
No text entered.  


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Schering-Plough
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: January 27, 2012
Health Authority: Philippines: Bureau of Food and Drugs