Last updated: 11/16/2021 13:40:04
Post-Market Clinical Follow-Up (PMCF) Study for Otrivin Sea Water pressurised sprays (with and without Aloe Vera)
GSK study ID
217004
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 Otrivin Sea Water pressurised
sprays (with and without Aloe Vera)
Trial description: The main aim of this study is to confirm the safety and performance of Otrivin Sea Water pressurised spray (with and without Aloe Vera) post-Certification Europe (CE) Mark for their respective indicated population, in accordance with (EU) MDR 2017/745 Annex XIV Part B and the guidance document MDCG 2020-7 PMCF Plan Template - A guide for manufacturers and notified bodies(April 2020).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Proportion of Participants Reported Adverse Events (AEs) and Serious Adverse Events (SAEs) While Using the Otrivin Sea Water Pressurised Sprays (With and Without Aloe Vera) During Survey Period
Timeframe: Approximately 1 year
Percentage of Participants Reported satisfaction on a 5-point scale Questionnaire
Timeframe: Approximately 1 year
Secondary outcomes:
Not applicable
Interventions:
Device: Otrivin Sea Water with Aloe Vera
Device: Otrivin Sea Water without Aloe Vera
Enrollment:
1110
Observational study model:
Ecologic or Community
Primary completion date:
2021-04-10
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Common cold
Product
Not applicable
Collaborators
Not applicable
Study date(s)
July 2021 to October 2021
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
0 - 99 Years
Accepts healthy volunteers
Yes
- Inclusion Criteria
- Participant is deemed suitable for inclusion in the investigation if both the following criteria are met :
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria
- Participant is deemed suitable for inclusion in the investigation if both the following criteria are met :
- Participant (adults/guardians* thereof) is reasonably able to operate an electronic resource and complete the questionnaire in an electronic format;
- Infants or children (adults/guardians* thereof) who have used the devices; or adults* who have used and adults* who have supervised the use of the devices in the previous 6 months, including women who are pregnant or breastfeeding.
- *Adult refers to person over the age of 18 years.
- Exclusion Criteria
- Participant will be excluded from the investigation if any of the following criteria are met:
- Participant (adults/guardians* thereof) is unable to operate an electronic resource and complete the questionnaire in an electronic format
- Participant (adults/guardians* thereof) has not used or supervised the use of Otrivin Sea Water pressurised spray (with and without Aloe Vera) 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
2021-04-10
Actual study completion date
2021-04-10
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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