Post Marketing Surveillance for Contac Bien Z in Japan

N/ACompletedNCT02020902

GlaxoSmithKline1,552 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,552

Conditions

Allergic Rhinitis Seasonal Allergic Rhinitis

Interventions

Cetrizine hydrochlorideOTHER

As provided on the patient information leaflet

Eligibility

Sex: ALLMin age: 15 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Drug Store Seki

Saitama, Japan

Outcomes

Primary Outcomes

Adverse events after having cetrizine hydrochloride

Participants will answer a questionnaire which consists of questions on safety of the marketed cetrizine hydrochloride formulation.

Time frame: At baseline

Secondary Outcomes

Efficacy of the marketed cetrizine hydrochloride formulation

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)

Time frame: At baseline

Data from ClinicalTrials.gov

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