Rhinitis, Allergic, Perennial Clinical Trial
Official title:
Post Marketing Surveillance of Alesion® (Epinastine Hydrochloride) Tablet
NCT number | NCT02238223 |
Other study ID # | 262.290 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | September 11, 2014 |
Last updated | September 11, 2014 |
Start date | April 2004 |
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 |
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
Status | Completed |
Enrollment | 2001 |
Est. completion date | |
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: - AlesionĀ® Tablet is contraindicated for the patients with history of hypersensitivity to any ingredients of AlesionĀ® 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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
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 |
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