Last updated: 01/17/2022 07:20:08
Questionnaire-based, PMCF Study to Assess the Safety and Performance of Prorhinel SpraysPMCF
GSK study ID
218285
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Observational, Questionnaire-based, Post-Market Clinical Follow-Up (PMCF) Study for Prorhinel Sprays (3 different nasal nozzles: Prorhinel Spray Infants-Young Children/Prorhinel Spray Infants- Children [Baby nozzle], Prorhinel Spray Children-Adults/Prorhinel Spray Adults [Regular nozzle], Prorhinel Spray Jet Tonic Adults [Jet nozzle])
Trial description: The purpose of this study is to further confirm the safety and performance of Prorhinel sprays post-European Conformity Marking (CE Mark) for its respective indicated populations.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Proportion of Participants who Reported Adverse Event (AE)/Side Effect (SE) or Device Malfunction (DM) in Previous 6 Months
Timeframe: 6 months prior to completing the online questionnaire
Percentage of Participants Reporting Satisfaction
Timeframe: 6 months prior to completing the online questionnaire
Secondary outcomes:
Not applicable
Interventions:
Device: Prorhinel Spray Infants-Young Children/Prorhinel spray Infants-Children
Device: Prorhinel Spray Children-Adults/Prorhinel Spray Adults
Device: Prorhinel Spray Jet Tonic Adults
Enrollment:
695
Observational study model:
Ecologic or Community
Primary completion date:
2021-30-12
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Common cold
Product
Not applicable
Collaborators
Not applicable
Study date(s)
December 2021 to December 2021
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- Participant (adult/parent/guardian/caregiver* thereof) is reasonably able to operate an electronic resource (for example [e.g.] access to computer, smartphone or tablet and sufficient internet access to connect to study platform) and complete the questionnaire in an electronic format.
- Infants/babies, children (parents/guardians/caregivers* thereof) or adults (including pregnant and breastfeeding women) who have been treated with/used the medical device in the previous 6 months.
- Participant (adult/parent/guardian/caregiver* thereof) is unable to operate an electronic resource (e.g. access to computer, smartphone or tablet and sufficient internet access to connect to study platform) and complete the questionnaire in an electronic format.
- Participant (adult/parent/guardian/caregiver* thereof) has not used or supervised the use of Prorhinel spray in the previous 6 months.
Inclusion and exclusion criteria
Inclusion criteria:
- Participant (adult/parent/guardian/caregiver* thereof) is reasonably able to operate an electronic resource (for example [e.g.] access to computer, smartphone or tablet and sufficient internet access to connect to study platform) and complete the questionnaire in an electronic format.
- Infants/babies, children (parents/guardians/caregivers* thereof) or adults (including pregnant and breastfeeding women) who have been treated with/used the medical device in the previous 6 months.
- Adults* who have supervised the use of the medical device in the previous 6 months. * Adult/guardian/caregiver refers to persons over the age of 18 years old.
Exclusion criteria:
- Participant (adult/parent/guardian/caregiver* thereof) is unable to operate an electronic resource (e.g. access to computer, smartphone or tablet and sufficient internet access to connect to study platform) and complete the questionnaire in an electronic format.
- Participant (adult/parent/guardian/caregiver* thereof) has not used or supervised the use of Prorhinel spray in the previous 6 months. *Adult/guardian/caregiver refers to persons over the age of 18 years old.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
2021-30-12
Actual study completion date
2021-30-12
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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