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Contac Bien Z Adverse Effect Survey

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02020902
First received: December 19, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  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

Resource links provided by NLM:


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


Estimated Enrollment: 1500
Study Start Date: March 2013
Estimated Study Completion Date: March 2016
Estimated 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
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

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Japan
Drug Store Seki Recruiting
Saitama, Japan, 340-0144
Contact: US GSK Clinical Trials Call Center    877-379-3718    info@GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    info@GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02020902     History of Changes
Other Study ID Numbers: RH01905
Study First Received: December 19, 2013
Last Updated: December 19, 2013
Health Authority: Pharmaceutical and Medical Devices Agency: Japan

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

ClinicalTrials.gov processed this record on November 20, 2014