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NCT02238249 Clinical Trial

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

Urticaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02238249
Other study ID # 262.294
Secondary ID
Status Completed
Phase N/A
First received September 11, 2014
Last updated September 11, 2014
Start date October 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 urticaria

Recruitment information / eligibility
Status Completed
Enrollment 122
Est. completion date
Est. primary completion date September 2007
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 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 exclusion criteria are not set in the protocol

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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) up to 2 years No
Primary Incidence of adverse drug reactions classified by patient's background/treatment factors up to 2 years No
Secondary Overall assessment of efficacy by investigator on a 3-point scale after 1 week No
See also
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Completed NCT01371877 - The Role of Vitamin D in Chronic Urticaria and Angioedema Treatment N/A
Completed NCT00751218 - A Comparative Double-Blind, Double- Dummy Study of Desloratadine (DL) 5 MG Once Daily, Cetirizine 10 MG Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (Study P03735) Phase 4
Completed NCT03137069 - A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU). Phase 2
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