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Post Marketing Surveillance for Contac Bien Z in Japan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02020902
First received: December 19, 2013
Last updated: May 12, 2016
Last verified: May 2016
  Purpose
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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
  Eligibility

Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants who purchase the marketed cetrizine hydrochloride formulation from pharmacy stores in Japan.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02020902

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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02020902     History of Changes
Other Study ID Numbers: 200638  RH01905 
Study First Received: December 19, 2013
Last Updated: May 12, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA)

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on December 02, 2016