Post Marketing Surveillance of Alesion® in Japanese Paediatric Patients With Allergic Rhinitis, Eczema/Dermatitis, Urticaria and Pruritus

Rhinitis, Allergic, Perennial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02238236
• Other study ID #: 262.293
• Status: Completed
• Phase: N/A
• First received: September 11, 2014
• Last updated: September 11, 2014
• Start date: May 2005

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 of Alesion® Dry Syrup under the proper use in daily clinical practice in Japanese paediatric patients with allergic rhinitis, eczema/dermatitis, urticaria and pruritus

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3793
• Est. primary completion date: April 2008
• 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, 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 was 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• Alesion®
Dry Syrup

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) terminology	up to 3 years	No
Primary	Incidence of adverse drug reactions classified by patient's background/treatment factors		up to 3 years	No
Secondary	Overall assessment of efficacy by investigator on a 3-point scale		At 12 weeks and 52 weeks	No

External Links

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