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

NCT ID: NCT00723736

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2008-06-30

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.

Detailed Description

Pediatric patients aged 1-5 years

Conditions

Rhinitis; Urticaria

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pediatric Patients

Those with allergic rhinitis or chronic idiopathic urticaria.

Desloratadine

Intervention Type: DRUG

2.5 ml (1.25 mg) once daily

Interventions

Desloratadine

2.5 ml (1.25 mg) once daily

Intervention Type: DRUG

Other Intervention Names

Aerius; SCH 034117

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P04446

Identifier Type: -

Identifier Source: org_study_id