Study to Investigate the Safety and Efficacy of Alesion® in Japanese Paediatric Patients With Urticaria
Completed
- Conditions
- Urticaria
- Interventions
- Drug: Alesion®
- Registration Number
- NCT02238249
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description paediatric patients with urticaria Alesion® -
- Primary Outcome Measures
Name Time Method Incidence of adverse drug reactions up to 2 years classified by Medical Dictionary for Regulatory Activities (MedDRA)
Incidence of adverse drug reactions classified by patient's background/treatment factors up to 2 years
- Secondary Outcome Measures
Name Time Method Overall assessment of efficacy by investigator on a 3-point scale after 1 week