Post Marketing Surveillance of Alesion® in Japanese Paediatric Patients With Allergic Rhinitis, Eczema/Dermatitis, Urticaria and Pruritus
Overview
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
Full Title of Study: “Post Marketing Surveillance of Alesion® (Epinastine Hydrochloride) Dry Syrup -Drug Use-Results Survey of Alesion® Dry Syrup-“
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: April 2008
Interventions
- Drug: Alesion®
- Dry Syrup
Arms, Groups and Cohorts
- Patients with allergic rhinitis, eczema/dermatitis, urticaria
Clinical Trial Outcome Measures
Primary Measures
- Incidence of adverse drug reactions
- Time Frame: up to 3 years
- classified by Medical Dictionary for Regulatory Activities (MedDRA) terminology
- Incidence of adverse drug reactions classified by patient’s background/treatment factors
- Time Frame: up to 3 years
Secondary Measures
- Overall assessment of efficacy by investigator on a 3-point scale
- Time Frame: At 12 weeks and 52 weeks
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Boehringer Ingelheim
- Provider of Information About this Clinical Study
- Sponsor
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