Last updated: 01/12/2022 07:30:04
Questionnaire-based, Post-Market Clinical Follow-Up (PMCF) Study to Assess the Safety and Effectiveness of 0.9 percent (%) sodium chloride (NaCl) and 0.74% NaCl Monodoses
GSK study ID
217867
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 Narhinel 0.9% NaCl Monodose and Otrisal 0.74% NaCl Monodose
Trial description: The purpose of this study is to confirm the safety and performance of Narhinel 0.9% NaCl Monodose and Otrisal 0.74% NaCl Monodose post- Certification Europe Mark (CE Mark) for their 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 or Device Malfunction 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: Narhinel 0.9% NaCl Monodose
Device: Otrisal 0.74% NaCl Monodose
Enrollment:
1126
Observational study model:
Ecologic or Community
Primary completion date:
2021-25-11
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Common cold
Product
sodium chloride
Collaborators
Not applicable
Study date(s)
October 2021 to November 2021
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- Participant (parent/guardian/caregiver over the age of 18 years old) is reasonably able to operate an electronic resource (for example, 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 (including babies less than [<]2 weeks old) or children (parent/guardian/caregiver, if minor) or adults (including pregnant or breastfeeding woman) who have used or administrated the medical device in the previous 6 months.
- Participant (parent/guardian/caregiver over the age of 18 years old) is unable to operate an electronic resource (access to computer, smartphone or tablet and sufficient Internet access to connect to study platform) and complete the questionnaire in an electronic format.
- Participant (parent/guardian/caregiver over the age of 18 years old) has not used or supervised the use of Narhinel 0.9% NaCl Monodose and/or Otrisal 0.74% NaCl Monodose in the previous 6 months.
Inclusion and exclusion criteria
Inclusion criteria:
- Participant (parent/guardian/caregiver over the age of 18 years old) is reasonably able to operate an electronic resource (for example, 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 (including babies less than [<]2 weeks old) or children (parent/guardian/caregiver, if minor) or adults (including pregnant or breastfeeding woman) who have used or administrated the medical device in the previous 6 months.
- Adults who have used or who have supervised the use of the medical device in the previous 6 months.
Exclusion criteria:
- Participant (parent/guardian/caregiver over the age of 18 years old) is unable to operate an electronic resource (access to computer, smartphone or tablet and sufficient Internet access to connect to study platform) and complete the questionnaire in an electronic format.
- Participant (parent/guardian/caregiver over the age of 18 years old) has not used or supervised the use of Narhinel 0.9% NaCl Monodose and/or Otrisal 0.74% NaCl Monodose in the previous 6 months.
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
2021-25-11
Actual study completion date
2021-25-11
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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