Drug Use Investigation for XYZAL®

Completed

• Conditions: Rhinitis, Allergic, Perennial and Seasonal
• Interventions: Drug: Levocetirizine

• Registration Number: NCT01445262
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This post-marketing surveillance study (PMS) is conducted to collect safety and efficacy data among subjects with allergic rhinitis, urticaria, eczema, dermatitis, skin irritation, prurigo or pruritus cutaneous who have never been treated with levocetirizine tablets before.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-09-29
• Study First Submitted QC: 2011-09-29
• Study First Posted: 2011-10-03
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-10
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10728

Inclusion Criteria

• Must be the first time for taking levocetirizine tablet

Exclusion Criteria

• As this is PMS study, there are no exclusion criteria.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects prescribed levocetirizine tablets	Levocetirizine	Subjects prescribed levocetirizine tablets for treatment of allergic rhinitis, urticaria, eczema, dermatitis, skin irritation, prurigo or pruritus cutaneous

Primary Outcome Measures

Name	Time	Method
The number of adverse events in Japanese subjects treated with levocetirizine tablets	4 weeks