Back to resultsStudy of the Effectiveness and Safety of Desloratadine (Aerius) Syrup in Children With Allergic Skin Inflammation (P03475)
Primary Purpose
Dermatitis, Atopic
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
desloratadine
Sponsored by
About this trial
This is an interventional treatment trial for Dermatitis, Atopic
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Demonstration of the efficacy of desloratadine in relieving the total symptoms of atopic dermatitis through SCORAD Index
Secondary Outcome Measures
The percent of subjects who rate their response to desloratadine as either Complete, Marked, or Moderate Relief
Evaluate the number of adverse events during therapy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00817076
Brief Title
Study of the Effectiveness and Safety of Desloratadine (Aerius) Syrup in Children With Allergic Skin Inflammation (P03475)
Official Title
Evaluation of the Efficacy and Safety of Desloratadine Syrup in Childhood Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
July 2003 (Actual)
Study Completion Date
July 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
desloratadine
Other Intervention Name(s)
Clarinex; Aerius; SCH 34117; descarboethoxyloratadine
Intervention Description
desloratadine syrup; 5.0 mL once daily for 28 days
Primary Outcome Measure Information:
Title
Demonstration of the efficacy of desloratadine in relieving the total symptoms of atopic dermatitis through SCORAD Index
Time Frame
Baseline, Day 8, Day 15, and Day 29
Secondary Outcome Measure Information:
Title
The percent of subjects who rate their response to desloratadine as either Complete, Marked, or Moderate Relief
Time Frame
Day 8, Day 15, and Day 29
Title
Evaluate the number of adverse events during therapy
Time Frame
Day 8, Day 15, and Day 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Study of the Effectiveness and Safety of Desloratadine (Aerius) Syrup in Children With Allergic Skin Inflammation (P03475)
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