Post Marketing Surveillance of Alesion® in Japanese Paedi... | NCT02238236

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

NCT02238236

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Sep 12, 2014Estimated

Enrollment

3,793Actual

Phase

Not provided

Conditions

Rhinitis, Allergic, Perennial

Interventions

Alesion®

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Apr 2008Actual

Completion Date

Not provided

First Submitted Date

Sep 11, 2014

First Submission Date that Met QC Criteria

Sep 11, 2014

First Posted Date

Sep 12, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2014

Last Update Posted Date

Sep 12, 2014Estimated

Description Module

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 allergic rhinitis, eczema/dermatitis, urticaria and pruritus

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,793Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with allergic rhinitis, eczema/dermatitis, urticaria			Drug: Alesion®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alesion®	Drug	Dry Syrup	Patients with allergic rhinitis, eczema/dermatitis, urticaria

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of adverse drug reactions	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		up to 3 years

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D012221	Rhinitis, Allergic, Perennial

Ancestor Terms

ID	Term
D065631	Rhinitis, Allergic
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided