ClinConnect ClinConnect Logo
Search / Trial NCT00817076

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

Launched by ORGANON AND CO · Jan 5, 2009

Trial Information

Current as of July 22, 2025

Completed

Keywords

ClinConnect Summary

No description provided

Gender

ALL

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.

About Organon And Co

Organon & Co. is a global healthcare company dedicated to advancing women's health and improving patient outcomes through innovative therapies and solutions. With a strong focus on addressing unmet medical needs, Organon develops and commercializes a diverse portfolio of medicines, including reproductive health, contraception, and other critical areas affecting women's health. Committed to scientific excellence and collaboration, the company engages in clinical trials to explore new treatment avenues and enhance the quality of life for patients worldwide. Through its mission-driven approach, Organon strives to empower women and healthcare providers with the tools and resources necessary for informed decision-making and effective care.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials