Postmarketing Surveillance to Investigate the Safety and Efficacy Information of Alesion® Tablet

Boehringer Ingelheim2,001 enrolled

Overview

Study to investigate the safety and efficacy information of Alesion® Tablet under the proper use in daily clinical practice after new treatment guideline for allergic rhinitis, bronchial asthma, eczema, dermatitis, urticaria, pruritus, prurigo and psoriasis vulgaris with itching

Study Type

OBSERVATIONAL

Enrollment

2,001

Conditions

Rhinitis, Allergic, Perennial

Interventions

Alesion®DRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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, prurigo, urticaria, psoriasis with itching, bronchial asthma Exclusion Criteria: * Alesion® Tablet is contraindicated for the patients with history of hypersensitivity to any ingredients of Alesion® Tablet in package insert. However, it is unknown whether a patient is hypersensitive to the ingredients of the product in almost cases. And this survey is drug utilization study to observe actual use in any patients. Therefore exclusion criteria is 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 24 months

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

Time frame: up to 24 months

Secondary Outcomes

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

Time frame: after 24 months

Data from ClinicalTrials.gov

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