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

Post Marketing Surveillance of Alesion® (Epinastine Hydrochloride) Dry Syrup -Special Drug Use-Results Survey of Alesion® Dry Syrup-

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02238249

Enrollment

122

Registered

2014-09-12

Start date

2005-10-31

Completion date

Unknown

Last updated

2014-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urticaria

Brief summary

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

Interventions

DRUGAlesion®

Dry Syrup

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of adverse drug reactions	up to 2 years	classified by Medical Dictionary for Regulatory Activities (MedDRA)
Incidence of adverse drug reactions classified by patient's background/treatment factors	up to 2 years	—

Secondary

Measure	Time frame
Overall assessment of efficacy by investigator on a 3-point scale	after 1 week

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026