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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 6 months to 11 years
• All sexes
• No healthy volunteers
• Child

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

About this study

Official title: Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Desloratadine Syrup Among Filipino Pediatric Patients

Conditions

Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial, Urticaria

Being tested

Desloratadine Syrup

Medical subject headings

Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial, Urticaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Desloratadine SyrupDrug

  Also called Aerius, Clarinex, SCH 34117, descarboethoxyloratadine

  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)

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Number of Adverse Events Reported By Category After 14 Days of Treatment

   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.

   Measured: 15 Days

2. Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment

   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.

   Measured: 15 Days

3. Participant Global Tolerability Assessment

   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.

   Measured: Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted29 Sep 2008 (estimated)
2. Study startMar 2008
3. Primary completionMay 2010
4. Study completionMay 2010

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Rhinitis, Allergic, SeasonalStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.