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Post Marketing Surveillance for Contac Bien Z in Japan

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: December 19, 2013
Last updated: May 12, 2016
Last verified: May 2016
This is a post-marketing surveillance study on a marketed cetrizine hydrochloride formulation.

Condition Intervention
Allergic Rhinitis
Seasonal Allergic Rhinitis
Other: Cetrizine hydrochloride

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Contac Bien Z Adverse Effect Survey

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Adverse events after having cetrizine hydrochloride [ Time Frame: At baseline ]
    Participants will answer a questionnaire which consists of questions on safety of the marketed cetrizine hydrochloride formulation.

Secondary Outcome Measures:
  • Efficacy of the marketed cetrizine hydrochloride formulation [ Time Frame: 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)

Enrollment: 1552
Study Start Date: March 2013
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Cetrizine hydrochloride
    As provided on the patient information leaflet

Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants who purchase the marketed cetrizine hydrochloride formulation from pharmacy stores in Japan.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT02020902

Drug Store Seki
Saitama, Japan, 340-0144
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT02020902     History of Changes
Other Study ID Numbers: 200638
RH01905 ( Other Identifier: GSK )
Study First Received: December 19, 2013
Last Updated: May 12, 2016

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on May 24, 2017