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

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00723736
• Collaborator: (none)
• Enrollment: 100
• Duration (Months): 6

Study Details

Study Description

Brief Summary

The objective of this non-interventional study is to evaluate the safety of Aerius syrup in pediatric patients aged 1-5 years old with allergic rhinitis or chronic idiopathic uticaria. The patients will receive 2.5 ml (1.25 mg) once daily.

Condition or Disease	Intervention/Treatment	Phase
Rhinitis; Urticaria	Drug: Desloratadine

Detailed Description

Pediatric patients aged 1-5 years

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Non-Interventional Study of the Safe Use of Aerius in Pediatric Patients With Allergic Rhinitis or Chronic Idiopathic Urticaria.
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Pediatric Patients Those with allergic rhinitis or chronic idiopathic urticaria.	Drug: Desloratadine; 2.5 ml (1.25 mg) once daily; Other Names: Aerius SCH 034117

Outcome Measures

Primary Outcome Measures

1. Proportion of Patients With Adverse Events [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with allergic rhinitis or chronic idiopathic urticaria

• Aged 1-5 years old

• Caregiver's consent to participate

Exclusion Criteria:

• Healthy individuals

• Younger or older than the 1-5 year old age range

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00723736
• Other Study ID Numbers: P04446
• First Posted: Jul 29, 2008
• Last Update Posted: Feb 9, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic; Urticaria; Chronic Urticaria; Desloratadine

Study Results

Participant Flow

Arm/Group Title	Aerius® Syrup
Arm/Group Description	Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
Period Title: Overall Study
STARTED	100
COMPLETED	99
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Aerius® Syrup
Arm/Group Description	Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
Overall Participants	100
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	3.1 (1.2)
Sex: Female, Male (Count of Participants)
Female	45 45%
Male	55 55%

Outcome Measures

1. Primary Outcome

Title	Proportion of Patients With Adverse Events
Description	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.
Time Frame	Follow-up visit at 3 - 5 weeks after treatment initiation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aerius® Syrup
Arm/Group Description	Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
Measure Participants	100
Gastrointestinal Disorders	20 20%
General Disorders & Administration Site Conditions	4 4%
Infections and Infestations	21 21%
Respiratory, Thoracic, and Mediastinal Disorders	6 6%
Skin and Subcutaneous Tissue Disorders	4 4%

Adverse Events

Arm/Group Title	Aerius® Syrup
Arm/Group Description	Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
All Cause Mortality
	Aerius® Syrup
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Aerius® Syrup
	Affected / at Risk (%)	# Events
Total	1/100 (1%)
Gastrointestinal disorders
Vomiting	1/100 (1%)	1
General disorders
Pyrexia	1/100 (1%)	1
Infections and infestations
Tonsillitis	1/100 (1%)	1
Metabolism and nutrition disorders
Dehydration	1/100 (1%)	1
Other (Not Including Serious) Adverse Events
	Aerius® Syrup
	Affected / at Risk (%)	# Events
Total	6/100 (6%)
Respiratory, thoracic and mediastinal disorders
Cough	6/100 (6%)	9

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.