Post Marketing Surveillance for Contac Bien Z in Japan

May 12, 2016 updated by: GlaxoSmithKline

Contac Bien Z Adverse Effect Survey

This is a post-marketing surveillance study on a marketed cetrizine hydrochloride formulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1552

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Saitama, Japan, 340-0144
        • Drug Store Seki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants who purchase the marketed cetrizine hydrochloride formulation from pharmacy stores in Japan.

Description

Inclusion Criteria:

  • Male and female participants, between 15-65 years of age, who purchase the marketed cetrizine hydrochloride formulation

Exclusion Criteria:

  • Who have ever experienced allergic symptoms by taking this medication or any component of this medication, piperazine derivative (including levocetirizine, hydroxizine)
  • Those who have been under 15en diagnosed with kidney disease
  • Children under 15 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events after having cetrizine hydrochloride
Time Frame: At baseline
Participants will answer a questionnaire which consists of questions on safety of the marketed cetrizine hydrochloride formulation.
At baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of the marketed cetrizine hydrochloride formulation
Time Frame: At baseline
Participants will answer a questionnaire which consists of questions on their satisfaction after taking the marketed cetrizine hydrochloride formulation. The efficacy will be measured on a 4 point scale (1 Efficacious; 2 Somewhat efficacious; 3 Not efficacious; 4 Not known)
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

December 19, 2013

First Submitted That Met QC Criteria

December 19, 2013

First Posted (Estimate)

December 25, 2013

Study Record Updates

Last Update Posted (Estimate)

May 16, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200638
  • RH01905 (Other Identifier: GSK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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