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

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00817076
First received: January 5, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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 Intervention Phase
Dermatitis, Atopic
Drug: desloratadine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of Desloratadine Syrup in Childhood Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

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 ]

Enrollment: 40
Study Start Date: March 2003
Study Completion Date: July 2003
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: desloratadine
desloratadine syrup; 5.0 mL once daily for 28 days
Other Name: Clarinex; Aerius; SCH 34117; descarboethoxyloratadine

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00817076     History of Changes
Other Study ID Numbers: P03475
Study First Received: January 5, 2009
Last Updated: January 5, 2009
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Desloratadine
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on April 17, 2014