Last updated: 11/03/2018 20:54:51
Post Marketing Surveillance for Contac Bien Z in Japan
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Contac Bien Z Adverse Effect Survey
Trial description: This is a post-marketing surveillance study on a marketed cetrizine hydrochloride formulation.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Adverse events after having cetrizine hydrochloride
Timeframe: At baseline
Secondary outcomes:
Efficacy of the marketed cetrizine hydrochloride formulation
Timeframe: At baseline
Interventions:
Other: Cetrizine hydrochloride
Enrollment:
1552
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Allergic Rhinitis
Product
cetirizine
Collaborators
Not applicable
Study date(s)
March 2013 to January 2016
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
15 - 65 years
Accepts healthy volunteers
No
- Male and female participants, between 15-65 years of age, who purchase the marketed cetrizine hydrochloride formulation
- 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
Inclusion and exclusion 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
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2016-31-01
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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