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

Rhinitis, Allergic, Perennial Clinical Trial

Official title:

Post Marketing Surveillance of Alesion® (Epinastine Hydrochloride) Tablet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02238223
• Other study ID #: 262.290
• Status: Completed
• Phase: N/A
• First received: September 11, 2014
• Last updated: September 11, 2014
• Start date: April 2004

Study information

• Verified date: September 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2001
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rhinitis, Allergic, Perennial

Intervention

Drug:
• Alesion®

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse drug reactions	classified by Medical Dictionary for Regulatory Activities (MedDRA)	up to 24 months	No
Primary	Incidence of adverse drug reactions classified by patient's background/treatment factors		up to 24 months	No
Secondary	Overall assessment of efficacy by investigator on a 3-point scale		after 24 months	No

External Links

•   Link