Trial Outcomes & Findings for Observation of Side Effects and Effectiveness of Desloratadine (Aerius) Syrup in Filipino Children (Study P05634) (NCT NCT00761527)

Last Updated: 2022-02-09

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

2980 participants

Primary outcome timeframe

15 Days

Results posted on

2022-02-09

Participant Flow

The total number of participants enrolled was 2980. A total of 2978 participants received at least one dose of study medication.

Participant milestones

Participant milestones
Measure	Desloratadine (Aerius) Syrup Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received 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)
Overall Study STARTED	2980
Overall Study Received One Dose of Study Medication	2978
Overall Study COMPLETED	2958
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Desloratadine (Aerius) Syrup Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received 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)
Overall Study Adverse Event	3
Overall Study Poor Compliance	8
Overall Study Lost to Follow-up	9
Overall Study Unknown reason	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Desloratadine (Aerius) Syrup n=2978 Participants Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received 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)
Age, Continuous	5.74 years STANDARD_DEVIATION 3.272 • n=5 Participants
Sex/Gender, Customized Male	1511 Participants n=5 Participants
Sex/Gender, Customized Female	1457 Participants n=5 Participants
Sex/Gender, Customized Missing Data	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 Days

Population: The Safety population included all participants who had taken at least one dose of Desloratadine Syrup.

Outcome measures

Outcome measures
Measure	Desloratadine (Aerius) Syrup n=2978 Participants Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received 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)
Number of Adverse Events Reported By Category After 14 Days of Treatment Total Number of AEs	26 Adverse Events
Number of Adverse Events Reported By Category After 14 Days of Treatment Number of Mild AEs	21 Adverse Events
Number of Adverse Events Reported By Category After 14 Days of Treatment Number of Moderate AEs	4 Adverse Events
Number of Adverse Events Reported By Category After 14 Days of Treatment Number of Severe AEs	1 Adverse Events
Number of Adverse Events Reported By Category After 14 Days of Treatment Number of Treatment-related AEs	20 Adverse Events
Number of Adverse Events Reported By Category After 14 Days of Treatment Number of Mild Treatment-related AEs	19 Adverse Events
Number of Adverse Events Reported By Category After 14 Days of Treatment Number of Moderate Treatment-related AEs	0 Adverse Events
Number of Adverse Events Reported By Category After 14 Days of Treatment Number of Severe Treatment-related AEs	1 Adverse Events
Number of Adverse Events Reported By Category After 14 Days of Treatment Number of SAEs	1 Adverse Events
Number of Adverse Events Reported By Category After 14 Days of Treatment Number of Treatment-related SAEs	0 Adverse Events

PRIMARY outcome

Timeframe: 15 Days

Population: The Safety population included all participants who had taken at least one dose of Desloratadine Syrup.

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.

Outcome measures

Outcome measures
Measure	Desloratadine (Aerius) Syrup n=2978 Participants Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received 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)
Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment Number of Participants with AEs	24 Participants
Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment Number of Participants with Mild AEs	21 Participants
Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment Number of Participants with Moderate AEs	2 Participants
Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment Number of Participants with Severe AEs	1 Participants
Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment Number of Participants with Treatment-related AEs	20 Participants
Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment Number of Participants with AEs - Temporary d/c	1 Participants
Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment Number of Participants with AEs - Permanent d/c	2 Participants
Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment Number of Participants with AEs - Withdrawal	2 Participants
Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment Number of Participants with SAEs	1 Participants
Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment Number of Participants with Treatment-related SAEs	0 Participants
Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment Number of Participants Who Died Due to AEs	0 Participants

PRIMARY outcome

Timeframe: Day 15

Population: The Safety population included all participants who had taken at least one dose of Desloratadine Syrup (N=2978). For 31 participants, tolerability was not assessed.

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.

Outcome measures

Outcome measures
Measure	Desloratadine (Aerius) Syrup n=2947 Participants Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received 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)
Participant Global Tolerability Assessment Excellent	1278 Participants
Participant Global Tolerability Assessment Very Good	1339 Participants
Participant Global Tolerability Assessment Good	307 Participants
Participant Global Tolerability Assessment Fair	15 Participants
Participant Global Tolerability Assessment Poor	8 Participants

SECONDARY outcome

Timeframe: Day 15

Population: ITT Population, which consisted of all participants who had taken at least one dose of Desloratadine Syrup and had a post baseline clinical efficacy assessment (N=2956). For 4 participants, a clinical efficacy assessment was not reported.

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.

Outcome measures

Outcome measures
Measure	Desloratadine (Aerius) Syrup n=2952 Participants Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received 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)
Investigator Assessment of Clinical Efficacy Improvement	2913 Participants
Investigator Assessment of Clinical Efficacy No Improvement	39 Participants
Investigator Assessment of Clinical Efficacy Worsened	0 Participants

Adverse Events

Desloratadine (Aerius) Syrup

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Desloratadine (Aerius) Syrup n=2978 participants at risk Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received 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)
Infections and infestations Pneumonia	0.03% 1/2978 • Number of events 1 • Safety Population included all participants who had taken at least one dose of Desloratadine Syrup.

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee SPONSOR is the owner of all the data in the record forms including subsequent reports relating to this study. The prescribing physicians \& investigators agree only to use such information to conduct the study \& will not be able to publish the results of any part of this study without previous written authorization from SPONSOR. By signing the protocol, the investigator accepts that the results may be used in written publications \& for the purpose of providing information to health professionals.
Publication restrictions are in place

Restriction type: OTHER