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):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00761527
First received: September 25, 2008
Last updated: February 17, 2014
Last verified: February 2014

September 25, 2008
February 17, 2014
March 2008
May 2010   (final data collection date for primary outcome measure)
  • 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.

  • 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 ]
Complete list of historical versions of study NCT00761527 on ClinicalTrials.gov Archive Site
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.
Efficacy in relieving symptoms (Clinical Cure, Improved, No Improvement, Worse) [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Observation of Side Effects and Effectiveness of Desloratadine (Aerius) Syrup in Filipino Children (Study P05634)(COMPLETED)
Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Desloratadine Syrup Among Filipino Pediatric Patients

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.

Physicians who commonly prescribed desloratadine treatment as standard care of treatment were selected enroll participants.

Observational
Observational Model: Ecologic or Community
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Rhinitis, Allergic, Seasonal
  • Rhinitis, Allergic, Perennial
  • Urticaria
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2980
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
6 Months to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00761527
P05634
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP