Study to Investigate the Safety and Efficacy of Alesion® in Japanese Paediatric Patients With Urticaria

Boehringer Ingelheim122 enrolled

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 urticaria

Study Type

OBSERVATIONAL

Enrollment

122

Conditions

Urticaria

Interventions

Alesion®DRUG

Dry Syrup

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * All the patients who: * haven't treatment experience of epinastine product entered the survey; * have 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 is 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

Outcomes

Primary Outcomes

Incidence of adverse drug reactions

classified by Medical Dictionary for Regulatory Activities (MedDRA)

Time frame: up to 2 years

Incidence of adverse drug reactions classified by patient's background/treatment factors

Time frame: up to 2 years

Secondary Outcomes

Overall assessment of efficacy by investigator on a 3-point scale

Time frame: after 1 week

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.