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

Tracking Information
First Received Date ^ICMJE	September 25, 2008
Last Updated Date	January 27, 2012
Start Date ^ICMJE	March 2008
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 27, 2012)	Number of Adverse Events Reported By Category After 14 Days of Treatment [ Time Frame: 15 Days ] [ Designated as safety issue: Yes ] Safety was assessed by determining the incidence of all Adverse Events (AE) which occurred between Baseline Visit (Day 1) & Final Visit (Day 15) & were recorded in Case Report Forms. Total number of AEs reported were presented in several categories. Classification, causality & intensity for AEs were determined by investigator after obtaining sufficient information. A Serious Adverse Event (SAE) was any adverse drug experience that resulted in: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity. Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment [ Time Frame: 15 Days ] [ Designated as safety issue: Yes ] Safety was assessed by determining the incidence of all AEs which occurred between Baseline Visit (Day 1) & Final Visit (Day 15) & were recorded in Case Report Forms. Number of participants experiencing AEs were presented in several categories. Some AEs lead to discontinuation (d/c). Classification, causality & intensity for AEs were determined by investigator. A SAE was any adverse drug experience that resulted in any of the following: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity. Participant Global Tolerability Assessment [ Time Frame: Day 15 ] [ Designated as safety issue: No ] The participant's global assessment of tolerability with the medication was assessed using a categorical scale as follows: Excellent Very Good Good Fair poor Parent or guardian of each participant followed up for a final visit after 14 days (Day 15) at which tolerability was rated and reported for entire treatment period. Number of participants in each category is presented.
Original Primary Outcome Measures ^ICMJE (submitted: September 26, 2008)	Overall safety and tolerability by adverse events [ Time Frame: End of treatment ] [ Designated as safety issue: Yes ] Overall safety and tolerability by patient's global assessment of tolerability of the medication (Excellent, Very Good, Good, Fair, Poor) [ Time Frame: End of treatment ] [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT00761527 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 27, 2012)	Investigator Assessment of Clinical Efficacy [ Time Frame: Day 15 ] [ Designated as safety issue: No ] Investigator assessment of clinical efficacy of Desloratadine Syrup in relieving participants' symptoms of either allergic rhinitis or chronic idiopathic urticaria at final visit (Day 15). The number of participants categorized by investigator as: improved, no improvement, or worsened was reported at Day 15.
Original Secondary Outcome Measures ^ICMJE (submitted: September 26, 2008)	Efficacy in relieving symptoms (Clinical Cure, Improved, No Improvement, Worse) [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Observation of Side Effects and Effectiveness of Desloratadine (Aerius) Syrup in Filipino Children (Study P05634)(COMPLETED)
Official Title ^ICMJE	Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Desloratadine Syrup Among Filipino Pediatric Patients
Brief Summary	The purpose of this study is to observe the side effects of desloratadine syrup and how effective it is in relieving symptoms of allergic rhinitis or hives in Filipino children. The participants will take desloratadine syrup for 14 days. At the end of treatment, side effects will be recorded, as well as how the participants tolerate the medication. Effectiveness will also be rated at the end of treatment.
Detailed Description	Physicians who commonly prescribed desloratadine treatment as standard care of treatment were selected enroll participants.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Ecologic or Community Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	A total of 3000 prospective outpatient pediatric participants with either allergic rhinitis or chronic idiopathic urticaria will be enrolled in the study coming from about 300 sites in the Phillipines
Condition ^ICMJE	Rhinitis, Allergic, Seasonal Rhinitis, Allergic, Perennial Urticaria
Intervention ^ICMJE	Drug: Desloratadine Syrup 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) Other Name: Aerius, Clarinex, SCH 34117, descarboethoxyloratadine
Study Group/Cohort (s)	Participants with allergic rhinitis or idiopathic urticaria Outpatient pediatric participants (ages 6 months-11 years) in the Philippines with a diagnosis of allergic rhinitis or chronic idiopathic urticaria. Intervention: Drug: Desloratadine Syrup
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	2980
Completion Date	May 2010
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Outpatient pediatric participants, male or female, aged 6 months to 11 years Diagnosis of allergic rhinitis or chronic idiopathic urticaria Exclusion Criteria: Known hypersensitivity to desloratadine
Gender	Both
Ages	6 Months to 11 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00761527
Other Study ID Numbers ^ICMJE	P05634
Has Data Monitoring Committee	No
Responsible Party	Schering-Plough
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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