Post Marketing Surveillance of Alesion® in Japanese Paediatric Patients With Allergic Rhinitis, Eczema/Dermatitis, Urticaria and Pruritus

Overview

Study to investigate the safety and efficacy of Alesion® Dry Syrup under the proper use in daily clinical practice in Japanese paediatric patients with allergic rhinitis, eczema/dermatitis, urticaria and pruritus

Full Title of Study: “Post Marketing Surveillance of Alesion® (Epinastine Hydrochloride) Dry Syrup -Drug Use-Results Survey of Alesion® Dry Syrup-“

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 2008

Interventions

  • Drug: Alesion®
    • Dry Syrup

Arms, Groups and Cohorts

  • Patients with allergic rhinitis, eczema/dermatitis, urticaria

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of adverse drug reactions
    • Time Frame: up to 3 years
    • classified by Medical Dictionary for Regulatory Activities (MedDRA) terminology
  • Incidence of adverse drug reactions classified by patient’s background/treatment factors
    • Time Frame: up to 3 years

Secondary Measures

  • Overall assessment of efficacy by investigator on a 3-point scale
    • Time Frame: At 12 weeks and 52 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • All the patients who: – haven't treatment experience of epinastine product; – have at least one out of following diseases. allergic rhinitis, eczema, dermatitis, pruritus, urticaria Exclusion Criteria:

  • Alesion® Dry Syrup is contraindicated for the patients with history of hypersensitivity to any ingredients of Alesion® Dry Syrup in package insert. However, it was unknown whether a patient was hypersensitive to the ingredients of the product in almost cases. And this survey was drug utilization study to observe actual use in any patients. Therefore exclusion criteria are not set in the protocol

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Sponsor

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