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Completed

NCT Number: NCT02238249

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

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

Completed

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Key information

Conditions

Urticaria Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All the patients who:
  • haven't treatment experience of epinastine product entered the survey;
  • have 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 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

Treatment and study plan

Alesion®

Drug

Dry Syrup

Primary outcomes

  1. Incidence of adverse drug reactions

    Time frame: up to 2 years

    classified by Medical Dictionary for Regulatory Activities (MedDRA)

  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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Post Marketing Surveillance of Alesion® (Epinastine Hydrochloride) Dry Syrup -Special Drug Use-Results Survey of Alesion® Dry Syrup-

Important dates

Study start
2005
Primary completion
2007
First posted
Sep 12, 2014
Registry last updated
Sep 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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