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

Rhinitis, Allergic, Seasonal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00761527
• Other study ID #: P05634
• Status: Completed
• Start date: March 2008
• Est. completion date: May 2010

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2980
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 11 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 Days
Primary	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.	15 Days
Primary	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.	Day 15
Secondary	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.	Day 15