NCT02238236

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,793

participants targeted

Target at P75+ for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
Last Updated

September 12, 2014

Status Verified

September 1, 2014

Enrollment Period

2.9 years

First QC Date

September 11, 2014

Last Update Submit

September 11, 2014

Conditions

Rhinitis, Allergic, Perennial

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • Overall assessment of efficacy by investigator on a 3-point scale

    At 12 weeks and 52 weeks

Study Arms (1)

Patients with allergic rhinitis, eczema/dermatitis, urticaria

Drug: Alesion®

Interventions

Alesion®DRUG

Dry Syrup

Patients with allergic rhinitis, eczema/dermatitis, urticaria

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2014

First Posted

September 12, 2014

Study Start

May 1, 2005

Primary Completion

April 1, 2008

Last Updated

September 12, 2014

Record last verified: 2014-09