Response of Desloratadine Syrup in the Relief of Symptoms Associated With Perennial Allergic Rhinitis in Pediatric Patients (Study P04299)

Overview

Evaluate the safety and general clinical response of desloratadine syrup in the relief of symptoms associated with perennial allergic rhinitis in Indonesian pediatric patients.

Full Title of Study: “Observational Study Evaluating the Safety and Efficacy of Desloratadine Syrup for Perennial Allergic Rhinitis in Indonesian Pediatric Patients”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2007

Detailed Description

Children, ages 2-11, with a history of perennial allergic rhinitis

Interventions

  • Drug: Desloratadine (assigned by investigator as part of normal practice)
    • Desloratadine syrup, 2.5 mL (1.25mg) once daily for 2-5 year olds, 5 mL (2.5mg) once daily for 6-11 year olds, minimum 7 days of treatment, minimum of 2 visits

Arms, Groups and Cohorts

  • 1
    • Children with a history of perennial allergic rhinitis

Clinical Trial Outcome Measures

Primary Measures

  • Adverse Events
    • Time Frame: Minimum of 7 days after initiation of desloratadine
    • An adverse event was defined in the protocol to include any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product (at any dose). Additionally, any event that is associated with or observed in conjunction with a product overdose (whether accidental or intentional) or a product abuse and/or withdrawal were also considered an adverse event. The investigator assessed the relationship of any adverse event as either unlikely, possibly, or probably related to the use of study drug based on available information and protocol guidelines.
  • General Clinical Response of Desloratadine Syrup Based on the Physician’s Judgments
    • Time Frame: Minimum of 7 days after initiation of desloratadine
    • Physicians judged the subjects as good, excellent, fair, or poor.

Participating in This Clinical Trial

Inclusion Criteria

  • Children patients of both sexes aged between 2-11 years, of either gender and any race – Unequivocal history of perennial allergic rhinitis, including nasal congestion, sneezing, rhinorrhea, pruritus, and lacrimation – Minimum score for inclusion: 10 – Capable of complying with the dosing regimen – Free of any clinically significant disease (other than allergic rhinitis) – Antihistamine must be justified by investigating doctor Exclusion Criteria:

  • Patients with asthma who require chronic use of inhaled or systemic corticosteroids – History of frequent, clinically significant sinusitis or chronic purulent postnasal drip – Patients with rhinitis medicamentosa – History of hypersensitivity to desloratadine or any of its excipients – Doctor deems unsuitable

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 11 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme Corp.
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.