Post Marketing Surveillance for Contac Bien Z in Japan

Allergic Rhinitis Clinical Trial

Official title:

Contac Bien Z Adverse Effect Survey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02020902
• Other study ID #: 200638
• Secondary ID: RH01905
• Status: Completed
• Phase: N/A
• First received: December 19, 2013
• Last updated: May 12, 2016
• Start date: March 2013
• Est. completion date: January 2016

Study information

• Verified date: May 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA)
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1552
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Other:
• Cetrizine hydrochloride
As provided on the patient information leaflet

Locations

Country	Name	City	State
Japan	Drug Store Seki	Saitama

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events after having cetrizine hydrochloride	Participants will answer a questionnaire which consists of questions on safety of the marketed cetrizine hydrochloride formulation.	At baseline	Yes
Secondary	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)	At baseline	No