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

Browse trials for

• Rhinitis 1,105
• Rhinitis, Allergic 1,030
• Rhinitis, Allergic, Seasonal 392
• Rhinitis, Allergic, Perennial 180
• Urticaria 237

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 2,980 is above the median of 141 across 172 observational studies indexed under Rhinitis.

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Study population

Groups and cohorts

• 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.

  Drug: Desloratadine Syrup

Interventions

• DrugDesloratadine 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)

  Also known as: Aerius, Clarinex, SCH 34117, descarboethoxyloratadine

Primary outcomes

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.

   Time frame: 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.

   Time frame: 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.

   Time frame: Day 15

Secondary outcomes

1. Investigator Assessment of Clinical Efficacy

   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.

   Time frame: Day 15

Baseline characteristics