Clincosm LogoSign in Get a demo

Study of the Effectiveness and Safety of Desloratadine (Aerius) Syrup in Children With Allergic Skin Inflammation (P03475)

Sponsor
Organon and Co (Industry)
Overall Status
Completed
CT.gov ID
NCT00817076
Collaborator
(none)
40
Enrollment
1
Arm
4
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study was to test the effectiveness and safety of desloratadine (Aerius) syrup in children with allergic skin inflammation. Patients took desloratadine syrup once a day for 28 days. Once a week, the doctor measured the patient's symptoms. This measurement is called SCORAD. The doctor also rated how much relief the patient got from treatment and recorded any side effects.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Efficacy and Safety of Desloratadine Syrup in Childhood Atopic Dermatitis
Study Start Date :
Mar 1, 2003
Actual Primary Completion Date :
Jul 1, 2003
Actual Study Completion Date :
Jul 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: desloratadine
desloratadine syrup; 5.0 mL once daily for 28 days
Other Names:
  • Clarinex; Aerius; SCH 34117; descarboethoxyloratadine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Demonstration of the efficacy of desloratadine in relieving the total symptoms of atopic dermatitis through SCORAD Index [Baseline, Day 8, Day 15, and Day 29]

    Secondary Outcome Measures

    1. The percent of subjects who rate their response to desloratadine as either Complete, Marked, or Moderate Relief [Day 8, Day 15, and Day 29]

    2. Evaluate the number of adverse events during therapy [Day 8, Day 15, and Day 29]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Children must be from >= 6 to < 12 years of age, of either sex and any race.

    • Children's parent(s) or legal representative(s) must demonstrate their willingness to participate in the study and comply with its procedures by signing an informed consent.

    • Children must be in general good health; i.e. they must be free of any clinically significant disease other than atopic dermatitis (AD) that would interfere with study evaluations.

    • Children's parent(s) or legal representative(s) must understand and be able to adhere to the dosing and visit schedule, and agree to report concomitant medications and adverse events to the Investigator or designee.

    • The diagnosis of AD will be performed according the Hanifin and Rajka criteria (Hanifin JM, Rajka G. Diagnostic features of atopic dermatitis. Acta Derm Venereol (Stockhr) 92 (suppl): 44-70, 1980): to be included in this study, children needed to manifest at least 3 major features and 3 minor features at visit 1 (day 1).

    • Children must be clinically symptomatic with AD at visit 1 (day 1). Disease severity will be estimated using the SCORAD Index (European task force on atopic dermatitis. Severity scoring of atopic dermatitis: the SCORAD Index. Dermatology 186: 23-31, 1993), and child must have a SCORAD Index at least >= 35.

    Exclusion Criteria:

    • Children who have not observed the designated washout period for any of the prohibited medications.

    • Children with bronchial asthma who require chronic use of inhaled or systemic corticosteroids.

    • Children with a history of hypersensitivity to desloratadine, or any of its excipients.

    • Children who have any current evidence of clinically significant hematopoietic, metabolic, cardiovascular, immunologic, neurologic, hematologic, gastrointestinal, hepatic, renal, psychiatric, or cerebrovascular, or any other disorder which, in the judgment of the Investigator, may interfere with the study evaluations or affect children safety.

    • A known lack or response to H1-antihistamines.

    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:
    NCT00817076
    Other Study ID Numbers:
    • P03475
    First Posted:
    Jan 6, 2009
    Last Update Posted:
    Feb 16, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Dermatitis, Atopic
    Dermatitis
    Desloratadine

    Study Results

    No Results Posted as of Feb 16, 2022