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OpenTrials
Completed

NCT Number: NCT02238223

Postmarketing Surveillance to Investigate the Safety and Efficacy Information of Alesion® Tablet

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

Completed

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Key information

Conditions

Rhinitis, Allergic, Perennial Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

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;
  • have at least one out of following diseases. allergic rhinitis, eczema, dermatitis, pruritus, prurigo, urticaria, psoriasis with itching, bronchial asthma

Exclusion criteria

  • Alesion® Tablet is contraindicated for the patients with history of hypersensitivity to any ingredients of Alesion® Tablet in package insert. However, it is unknown whether a patient is hypersensitive to the ingredients of the product in almost cases. And this survey is drug utilization study to observe actual use in any patients. Therefore exclusion criteria is not set in the protocol

Treatment and study plan

Alesion®

Drug

Primary outcomes

  1. Incidence of adverse drug reactions

    Time frame: up to 24 months

    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 24 months

Secondary outcomes

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

    Time frame: after 24 months

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Post Marketing Surveillance of Alesion® (Epinastine Hydrochloride) Tablet

Important dates

Study start
2004
Primary completion
2006
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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