Drug Use Investigation for XYZAL (Levocetirizine)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01445262
First received: September 29, 2011
Last updated: June 6, 2013
Last verified: May 2013
  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: The Drug Use Investigation is Conducted for the Purpose of Grasping the Presence or Absence of Problems and Questions Related to Safety and Efficacy Under Actual Conditions of XYZAL (Levocetirizine) Use

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10000
Study Start Date: February 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01445262

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01445262     History of Changes
Other Study ID Numbers: 115066
Study First Received: September 29, 2011
Last Updated: June 6, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Rhinitis
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
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014