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CompletedNCT02238249Updated Sep 12, 2014

Study to Investigate the Safety and Efficacy of Alesion® in Japanese Paediatric Patients With Urticaria

An observational study in Urticaria, sponsored by Boehringer Ingelheim. Completed. Per ClinicalTrials.gov, last updated 2014-09-12.

Sponsored by Boehringer Ingelheim · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
122
Sex
All
01

Study 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

02

Conditions studied

  • Urticaria

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03

In context

Urticaria

237 studies on the registry are indexed under Urticaria; 26 are open to participants now.

This study's enrollment of 122 is below the median of 162 across 52 observational studies indexed under Urticaria.

Browse Urticaria studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with urticaria and without experience in treatment with epinastine are selected by physicians at medical institutions

Inclusion criteria

  • All the patients who:

    • haven't treatment experience of epinastine product entered the survey;
    • have urticaria

Exclusion criteria

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 is 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
122 participants (actual)
Patient registry
No

Groups and cohorts

  • paediatric patients with urticaria

    Drug: Alesion®

Interventions

  • DrugAlesion®

    Dry Syrup

06

What researchers measure

Primary outcomes

  1. Incidence of adverse drug reactions

    classified by Medical Dictionary for Regulatory Activities (MedDRA)

    Time frame: up to 2 years

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

    Time frame: up to 2 years

Secondary outcomes

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

    Time frame: after 1 week

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02238249
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Sep 12, 2014
Start date
Oct 2005
Primary completion
Sep 2007
Last update
Sep 12, 2014
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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