Last updated: 04/29/2020 06:00:04
Safety of GlaxoSmithKline consumer health (GSKCH) Over-the-Counter (OTC) Product Flunase in Japanese Population
GSK study ID
210010
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: Post-marketing Surveillance for OTC Flunase
Trial description: The purpose of this post-marketing surveillance study is to collect safety information by the use of Flunase Nasal Spray (for seasonal allergies only) over the period of 3 years from the date of launch in Japanese Population.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of Participants with an Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: 3 years
Number of Participants with Indicated Unexpected Serious Adverse Events (SAEs)
Timeframe: 3 years
Number of Participants who followed the Usage Directions as per the Approved Patient Information Leaflet
Timeframe: 3 years
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
1000
Primary completion date:
2022-31-10
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Rhinitis, Allergic, Seasonal
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
November 2019 to October 2022
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
15+ years
Accepts healthy volunteers
No
- Participants using OTC Flunase with seasonal allergic rhinitis.
- Persons who have been diagnosed with the following condition
- Systemic mycosis, tuberculous disease, recurrent epistaxis, infectious disease
Inclusion and exclusion criteria
Inclusion criteria:
- Participants using OTC Flunase with seasonal allergic rhinitis.
Exclusion criteria:
- Persons who have been diagnosed with the following condition Systemic mycosis, tuberculous disease, recurrent epistaxis, infectious disease
- Persons with suppuration in the nasal cavities (infection of the hair roots, accompanied by pus accumulation, pain and swelling).
- Persons who have developed allergic symptoms caused by this product or fluticasone propionate preparations
- Persons under the age of 15 years
- Pregnant women or women suspected of being pregnant.
- Persons who have used steroidal nasal drops for more than 3 months out of the past year.
- Persons who use other steroidal nasal drops.
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Additional information
Not applicable
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