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Post Marketing Surveillance for Contac Bien Z in Japan

Contac Bien Z Adverse Effect Survey

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02020902
Enrollment
1552
Registered
2013-12-25
Start date
2013-03-31
Completion date
2016-01-31
Last updated
2016-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis, Seasonal Allergic Rhinitis

Brief summary

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

Interventions

OTHERCetrizine hydrochloride

As provided on the patient information leaflet

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adverse events after having cetrizine hydrochlorideAt baselineParticipants will answer a questionnaire which consists of questions on safety of the marketed cetrizine hydrochloride formulation.

Secondary

MeasureTime frameDescription
Efficacy of the marketed cetrizine hydrochloride formulationAt baselineParticipants 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)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026