Post Marketing Surveillance for Contac Bien Z in Japan

NCT ID: NCT02020902

Last Updated: 2016-05-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1552 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2016-01-31

Brief Summary

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

Conditions

Allergic Rhinitis; Seasonal Allergic Rhinitis

Study Design

• Study Time Perspective: PROSPECTIVE

Interventions

Cetrizine hydrochloride

As provided on the patient information leaflet

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Drug Store Seki

Saitama, , Japan

Countries

Japan

Other Identifiers

RH01905

Identifier Type: OTHER

Identifier Source: secondary_id

200638

Identifier Type: -

Identifier Source: org_study_id