Response of Desloratadine Syrup in the Relief of Symptoms Associated With Perennial Allergic Rhinitis in Pediatric Patients (Study P04299)
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|ClinicalTrials.gov Identifier: NCT00704769|
Recruitment Status : Completed
First Posted : June 25, 2008
Results First Posted : August 11, 2009
Last Update Posted : June 22, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Evaluate the safety and general clinical response of desloratadine syrup in the relief of symptoms associated with perennial allergic rhinitis in Indonesian pediatric patients.
|Condition or disease||Intervention/treatment|
|Rhinitis||Drug: Desloratadine (assigned by investigator as part of normal practice)|
Children, ages 2-11, with a history of perennial allergic rhinitis
|Study Type :||Observational|
|Actual Enrollment :||591 participants|
|Official Title:||Observational Study Evaluating the Safety and Efficacy of Desloratadine Syrup for Perennial Allergic Rhinitis in Indonesian Pediatric Patients|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
Children with a history of perennial allergic rhinitis
Drug: Desloratadine (assigned by investigator as part of normal practice)
Desloratadine syrup, 2.5 mL (1.25mg) once daily for 2-5 year olds, 5 mL (2.5mg) once daily for 6-11 year olds, minimum 7 days of treatment, minimum of 2 visits
Other Name: SCH 034117
Primary Outcome Measures :
- Adverse Events [ Time Frame: Minimum of 7 days after initiation of desloratadine ]An adverse event was defined in the protocol to include any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product (at any dose). Additionally, any event that is associated with or observed in conjunction with a product overdose (whether accidental or intentional) or a product abuse and/or withdrawal were also considered an adverse event. The investigator assessed the relationship of any adverse event as either unlikely, possibly, or probably related to the use of study drug based on available information and protocol guidelines.
- General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments [ Time Frame: Minimum of 7 days after initiation of desloratadine ]Physicians judged the subjects as good, excellent, fair, or poor.
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