- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00817076
Study of the Effectiveness and Safety of Desloratadine (Aerius) Syrup in Children With Allergic Skin Inflammation (P03475)
February 7, 2022 updated by: Organon and Co
Evaluation of the Efficacy and Safety of Desloratadine Syrup in Childhood Atopic Dermatitis
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
desloratadine syrup; 5.0 mL once daily for 28 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Baseline, Day 8, Day 15, and Day 29
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Day 8, Day 15, and Day 29
|
Evaluate the number of adverse events during therapy
Time Frame: Day 8, Day 15, and Day 29
|
Day 8, Day 15, and Day 29
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2003
Primary Completion (Actual)
July 1, 2003
Study Completion (Actual)
July 1, 2003
Study Registration Dates
First Submitted
January 5, 2009
First Submitted That Met QC Criteria
January 5, 2009
First Posted (Estimate)
January 6, 2009
Study Record Updates
Last Update Posted (Actual)
February 16, 2022
Last Update Submitted That Met QC Criteria
February 7, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Genetic Diseases, Inborn
- Skin Diseases, Genetic
- Hypersensitivity
- Skin Diseases, Eczematous
- Dermatitis
- Dermatitis, Atopic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Antagonists
- Cholinergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Desloratadine
Other Study ID Numbers
- P03475
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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