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Drug Use Investigation for XYZAL®

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01445262
First Posted: October 3, 2011
Last Update Posted: August 13, 2015
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.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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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.
Criteria

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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01445262     History of Changes
Other Study ID Numbers: 115066
First Submitted: September 29, 2011
First Posted: October 3, 2011
Last Update Posted: August 13, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Levocetirizine
Cetirizine
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