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

Post Marketing Surveillance of Alesion® (Epinastine Hydrochloride) Tablet

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02238223
Enrollment
2001
Registered
2014-09-12
Start date
2004-04-30
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

Rhinitis, Allergic, Perennial

Brief summary

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

Interventions

Sponsors

Boehringer Ingelheim
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of adverse drug reactionsup to 24 monthsclassified by Medical Dictionary for Regulatory Activities (MedDRA)
Incidence of adverse drug reactions classified by patient's background/treatment factorsup to 24 months

Secondary

MeasureTime frame
Overall assessment of efficacy by investigator on a 3-point scaleafter 24 months

Outcome results

None listed

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