NCT01445262

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,728

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2011

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 3, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

2.8 years

First QC Date

September 29, 2011

Last Update Submit

August 10, 2015

Conditions

Rhinitis, Allergic, Perennial and Seasonal

Outcome Measures

Primary Outcomes (1)

  • The number of adverse events in Japanese subjects treated with levocetirizine tablets

    4 weeks

Study Arms (1)

Subjects prescribed levocetirizine tablets

Subjects prescribed levocetirizine tablets for treatment of allergic rhinitis, urticaria, eczema, dermatitis, skin irritation, prurigo or pruritus cutaneous

Drug: Levocetirizine

Interventions

LevocetirizineDRUG
Subjects prescribed levocetirizine tablets

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Must be the first time for taking levocetirizine tablet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rhinitis

Interventions

levocetirizine

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2011

First Posted

October 3, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

August 13, 2015

Record last verified: 2015-08