Study of the Effectiveness and Safety of Desloratadine (Aerius) Syrup in Children With Allergic Skin Inflammation (P03475)
This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: January 5, 2009
Last updated: April 30, 2014
Last verified: April 2014
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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Evaluation of the Efficacy and Safety of Desloratadine Syrup in Childhood Atopic Dermatitis
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Evaluate the number of adverse events during therapy [ Time Frame: Day 8, Day 15, and Day 29 ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2003 (Final data collection date for primary outcome measure)
desloratadine syrup; 5.0 mL once daily for 28 days
Other Name: Clarinex; Aerius; SCH 34117; descarboethoxyloratadine
|Ages Eligible for Study:
||6 Years to 12 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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No publications provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 5, 2009
||April 30, 2014
||Italy: Ministry of Health
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2014
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists