Last updated: 07/06/2021 11:50:04
A safety survey of Panadol Antigripal NF in Peru
GSK study ID
213752
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Planned
Planned
Trial overview
Official title: A phase IV, post-marketing safety survey of Panadol Antigripal NF in Peru
Trial description: The main aim of this study is to describe the safety profile of Panadol Antigripal NF (ANF), when used according to label recommendations, through a post-marketing survey in Peru as requested by the Bureau of Health.
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 Panadol ANF During Survey Period
Timeframe: Approximately 6 months during the 2021 influenza season
Secondary outcomes:
Not applicable
Interventions:
Drug: Panadol ANF
Enrollment:
481
Observational study model:
Cohort
Primary completion date:
2023-01-04
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Common cold, Influenza, Human
Product
Not applicable
Collaborators
Not applicable
Study date(s)
December 2022 to April 2023
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
12 - 120 Years
Accepts healthy volunteers
Yes
- Inclusion Criteria
- To be eligible for this study, a participant must meet all of the following criteria:
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria To be eligible for this study, a participant must meet all of the following criteria:
- Participant has taken at least one dose of their most recent course of Panadol ANF within the past 7 days at the time of completing the screening questionnaire.
- Participant (or parent/guardian of the participants between 12 to 18 years of age) who is willing and able to complete an online questionnaire regarding their Panadol ANF use, and provides an active email account for questionnaire access and reminders. Exclusion Criteria Participants will be excluded from the study if they fulfill any of the following criteria:
- Participant (or parent/guardian of the participant) who is not willing or able to provide informed consent.
- Any prior sensitivity to paracetamol, phenylephrine, dextromethorphan, chlorphenamine or any of the excipients.
- Participants who are taking or have taken monoamine oxidase inhibitors (MAOIs) within the past 2 weeks.
- Participants with a current diagnosis of pneumonia or lower respiratory tract infection, lung abscess, acute bronchitis, or worsening asthma or chronic obstructive pulmonary disease (COPD).
- Participants who have taken one ore more doses of paracetamol or any other paracetamol-containing product concurrent with Panadol ANF during the survey period (interval between reported first dose of Panadol ANF and date of safety questionnaire).
- Participants who have received a positive test result [including molecular/polymerase chain reaction (PCR) tests or antigen tests] for coronavirus disease 2019 (COVID-19) during the past 30 days at the time of survey screening.
- Participant with acute respiratory illness (fever and at least one sign/symptom of respiratory disease, e.g., cough, shortness of breath), AND a history of travel from their primary residence to a location reporting community transmission of COVID-19 disease during the 14 days prior to symptom onset.
- Participant with any acute respiratory illness AND having been in contact with a confirmed or probable COVID-19 case (see definition of contact in Screening Questionaire, Appendix Section 10.1) in the last 14 days prior to symptom onset.
- Participant with severe acute respiratory illness (fever and at least one sign/symptom of respiratory disease, e.g., cough, shortness of breath; AND requiring hospitalization) AND in the absence of an alternative diagnosis that fully explains the clinical presentation.
- Participant with recent onset of anosmia (loss of smell) or ageusia (loss of taste) in the absence of any other identified cause.
- A suspect case for whom testing for the COVID-19 virus is inconclusive (Inconclusive being the result of the test reported by the laboratory).
- A suspect case of COVID-19 for whom testing could not be performed for any reason.
- Participant (or parent/guardian of the participant) who are directly involved in conduct of the study, or their family members.
Participant with any self-reported contraindication to Panadol ANF, as per label instructions, including the following:
Participants who have a suspected or probable case of COVID-19 [according to adapted World Health Organization (WHO) criteria (3, 4) listed below, revised for the current study design] during the past 30 days at the time of survey screening as per following criteria:
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Planned
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
Not applicable
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