We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Drug Use Investigation for XYZAL®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01445262
Recruitment Status : Completed
First Posted : October 3, 2011
Last Update Posted : August 13, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Rhinitis, Allergic, Perennial and Seasonal Drug: Levocetirizine

Study Design

Study Type : Observational
Actual Enrollment : 10728 participants
Time Perspective: Prospective
Official Title: Drug Use Investigation for XYZAL
Study Start Date : February 2011
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01445262

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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01445262     History of Changes
Other Study ID Numbers: 115066
First Posted: October 3, 2011    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 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