NCT02238223

Brief Summary

Study to investigate the safety and efficacy information of Alesion® Tablet under the proper use in daily clinical practice after new treatment guideline for allergic rhinitis, bronchial asthma, eczema, dermatitis, urticaria, pruritus, prurigo and psoriasis vulgaris with itching

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,001

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

April 1, 2004

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
8.4 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

2.1 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)

    up to 24 months

  • Incidence of adverse drug reactions classified by patient's background/treatment factors

    up to 24 months

Secondary Outcomes (1)

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

    after 24 months

Study Arms (1)

Patients without experience in treatment with epinastine

Drug: Alesion®

Interventions

Alesion®DRUG
Patients without experience in treatment with epinastine

Eligibility Criteria

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

Patients without experience treating of 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, prurigo, urticaria, psoriasis with itching, bronchial asthma

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

April 1, 2004

Primary Completion

May 1, 2006

Last Updated

September 12, 2014

Record last verified: 2014-09