Drug Use Investigation for XYZAL®

Rhinitis, Allergic, Perennial and Seasonal Clinical Trial

Official title:

Drug Use Investigation for XYZAL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01445262
• Other study ID #: 115066
• Status: Completed
• Phase: N/A
• First received: September 29, 2011
• Last updated: August 10, 2015
• Start date: February 2011
• Est. completion date: December 2013

Study information

• Verified date: August 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10728
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Rhinitis, Allergic, Perennial
• Rhinitis, Allergic, Perennial and Seasonal

Intervention

Drug:
• Levocetirizine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of adverse events in Japanese subjects treated with levocetirizine tablets		4 weeks	Yes