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

September 11, 2014 updated by: Boehringer Ingelheim

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3793

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Paediatric patients without experience in Treatment with epinastine are selected by physicians at medical institutions

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with allergic rhinitis, eczema/dermatitis, urticaria
Drug: Alesion®
Dry Syrup

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse drug reactions
Time Frame: up to 3 years
classified by Medical Dictionary for Regulatory Activities (MedDRA) terminology
up to 3 years
Incidence of adverse drug reactions classified by patient's background/treatment factors
Time Frame: up to 3 years
up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall assessment of efficacy by investigator on a 3-point scale
Time Frame: At 12 weeks and 52 weeks
At 12 weeks and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

September 11, 2014

First Submitted That Met QC Criteria

September 11, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Estimate)

September 12, 2014

Last Update Submitted That Met QC Criteria

September 11, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 262.293

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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