NCT02238249

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-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

October 1, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
7 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

1.9 years

First QC Date

September 11, 2014

Last Update Submit

September 11, 2014

Conditions

Urticaria

Outcome Measures

Primary Outcomes (2)

  • Incidence of adverse drug reactions

    classified by Medical Dictionary for Regulatory Activities (MedDRA)

    up to 2 years

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

    up to 2 years

Secondary Outcomes (1)

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

    after 1 week

Study Arms (1)

paediatric patients with urticaria

Drug: Alesion®

Interventions

Alesion®DRUG

Dry Syrup

paediatric patients with urticaria

Eligibility Criteria

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

Patients with urticaria and 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 entered the survey;
  • have urticaria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urticaria

Condition Hierarchy (Ancestors)

Skin Diseases, VascularSkin DiseasesSkin and Connective Tissue 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

October 1, 2005

Primary Completion

September 1, 2007

Last Updated

September 12, 2014

Record last verified: 2014-09