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Drug Use Investigation for XYZAL®

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: September 29, 2011
Last updated: August 10, 2015
Last verified: August 2015
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.

Condition Intervention
Rhinitis, Allergic, Perennial and Seasonal
Drug: Levocetirizine

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Drug Use Investigation for XYZAL

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The number of adverse events in Japanese subjects treated with levocetirizine tablets [ Time Frame: 4 weeks ]

Enrollment: 10728
Study Start Date: February 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects prescribed levocetirizine tablets
Subjects prescribed levocetirizine tablets for treatment of allergic rhinitis, urticaria, eczema, dermatitis, skin irritation, prurigo or pruritus cutaneous
Drug: Levocetirizine


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Japanese male and female subjects without age restriction who were considered appropriate to prescribe levocetirizine tablet according to the prescribing information were eligible for this surveillance study.

Inclusion Criteria:

  • Must be the first time for taking levocetirizine tablet

Exclusion Criteria:

  • As this is PMS study, there are no exclusion criteria.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01445262

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT01445262     History of Changes
Other Study ID Numbers: 115066
Study First Received: September 29, 2011
Last Updated: August 10, 2015

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents processed this record on May 25, 2017