Post Marketing Surveillance for Contac Bien Z in Japan

Completed

• Conditions: Allergic Rhinitis; Seasonal Allergic Rhinitis

• Registration Number: NCT02020902
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-25
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1552

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events after having cetrizine hydrochloride	At baseline	Participants will answer a questionnaire which consists of questions on safety of the marketed cetrizine hydrochloride formulation.

Secondary Outcome Measures

Name	Time	Method
Efficacy of the marketed cetrizine hydrochloride formulation	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)

Trial Locations

Locations (1)

Drug Store Seki; 🇯🇵 Saitama, Japan