Trial Outcomes & Findings for Safety of Aerius Syrup in Pediatric Patients Aged 1-5 Years Old With Allergic Rhinitis or Chronic Idiopathic Urticaria (Study P04446AM1)(COMPLETED) (NCT NCT00723736)

Results Overview

An adverse event is any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product, whether or not considered related to the use of that product. This includes the onset of new illness and the exacerbation of pre-existing conditions.

Recruitment status

COMPLETED

Target enrollment

100 participants

Primary outcome timeframe

Follow-up visit at 3 - 5 weeks after treatment initiation

Results posted on

2022-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	Aerius® Syrup Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
Overall Study STARTED	100
Overall Study COMPLETED	99
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety of Aerius Syrup in Pediatric Patients Aged 1-5 Years Old With Allergic Rhinitis or Chronic Idiopathic Urticaria (Study P04446AM1)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aerius® Syrup n=100 Participants Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
Age, Continuous	3.1 years STANDARD_DEVIATION 1.2 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants

PRIMARY outcome

Timeframe: Follow-up visit at 3 - 5 weeks after treatment initiation

An adverse event is any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product, whether or not considered related to the use of that product. This includes the onset of new illness and the exacerbation of pre-existing conditions.

Outcome measures

Outcome measures
Measure	Aerius® Syrup n=100 Participants Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
Proportion of Patients With Adverse Events Gastrointestinal Disorders	20 participants
Proportion of Patients With Adverse Events General Disorders & Administration Site Conditions	4 participants
Proportion of Patients With Adverse Events Infections and Infestations	21 participants
Proportion of Patients With Adverse Events Respiratory, Thoracic, and Mediastinal Disorders	6 participants
Proportion of Patients With Adverse Events Skin and Subcutaneous Tissue Disorders	4 participants

Adverse Events

Aerius® Syrup

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Aerius® Syrup n=100 participants at risk Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
Gastrointestinal disorders Vomiting	1.0% 1/100 • Number of events 1
General disorders Pyrexia	1.0% 1/100 • Number of events 1
Infections and infestations Tonsillitis	1.0% 1/100 • Number of events 1
Metabolism and nutrition disorders Dehydration	1.0% 1/100 • Number of events 1

Other adverse events

Other adverse events
Measure	Aerius® Syrup n=100 participants at risk Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
Respiratory, thoracic and mediastinal disorders Cough	6.0% 6/100 • Number of events 9

Additional Information

Senior Vice President, Global Clinical Development

Merck, Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any trial related information may be released by the PI to third party only after written consent is obtained from the sponsor. This restriction is valid until 5 years after study closure.
Publication restrictions are in place

Restriction type: OTHER