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

Boehringer Ingelheim

Status: Completed

Conditions: Rhinitis, Allergic, Perennial

Treatments: Drug: Alesion®

Study type: Observational

Funder types: Industry

Identifiers

NCT02238236

262.293

Details and patient eligibility

About

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

Enrollment: 3,793 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

3,793 participants in 1 patient group

Patients with allergic rhinitis, eczema/dermatitis, urticaria

Treatment:

Drug: Alesion®