Sore-throatPMCFNCT05985837
Post Market Clinical Follow-Up Study - Medical Device KalobaGOLA ( PMCF )
An observational study of Sore-throat and Pharyngitis, run by Schwabe Pharma Italia at 1 site in Italy.
Trial summary
The goal of this observational PMCF study is to confirm the efficacy and safety of the medical device KalobaGola (oral spray and tablets) in children, adolescents and adults with sore throat and /or pharyngitis. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Sore-throat, Pharyngitis
- What is being tested?
- KalobaGOLA spray (1), KalobaGOLA spray (2) and KalobaGOLA tablets
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 2 Aug 2023to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Customers of the pharmacies/parapharmacies involved
Who may be able to join
- KalobaGOLA spray: children from 1 year, adolescents and adults, both sexes, with symptoms of sore throat (burning sensation, pharyngitis, pain on swallowing), who / whose parents or caregivers bought the product by the pharmacy/parapharmacy involved.
- KalobaGOLA tablets: children from 6 years, adolescents and adults, both sexes, with symptoms of sore throat (burning sensation, pharyngitis, pain on swallowing), who / whose parents or caregivers bought the product by the pharmacy/parapharmacy involved.
Who cannot join
- KalobaGOLA spray: children aged < 1 year, people without sore throat symptoms
- KalobaGOLA tablets: children aged < 6 years, people without sore throat symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Market Clinical Follow-Up Study on Medical Devices KalobaGola Useful for Sore Throat and/or Pharyngitis in Adults and Children
The goal of this observational PMCF study is to confirm the efficacy and safety of the medical device KalobaGola (oral spray and tablets) in children, adolescents and adults with sore throat and /or pharyngitis. The main questions it aims to answer are:
- Is the product effective in the treatment of sore throat / pharyingits?
- Is the product safe?
After buying the product, participants will be asked to fill in a questionnaire, in order to:
- Assess the sore throat symptoms before the use of the spray or tablets.
- Assess the resolution of sore throat / pharyngitis symptoms after the use of the spray or tablets.
- Describe the adverse effect(s)/problem(s) observed while using the product (if any).
Read the detailed description
The Medical Device Regulation (EU) 2017/745 (MDR) considers post-market clinical follow-up (PMCF) as a continuous process that aims to update the clinical evaluation and validate or reassess the benefit-risk balance of the medical device. The PMCF is an integral part of the manufacturer's post-market surveillance plan (PMS).
The medical devices in question are both CE marked since 2020, with no substantial modification.
The objectives of this Post Market Clinical Follow Up (PMCF) study are: verify the use of these devices in a real situation, verify if their efficacy and safety of use are aligned with the provisions of the clinical evaluation; confirm or reassess the benefit/risk balance; update the risk analysis; identify any need for CAPA.
Specific product questionnaires have been developed based on the validated STAT-10 questionnaire, which aim to investigate aspects of Real-World Evidence on efficacy, safety, even in specific categories or situations, known and unknown adverse events, difficulties in use or completeness and clarity of IFUs.
Given the low-risk class of the devices (class IIa - Dir. 93/42/EEC), which are intended for use by lay people and normally sold in pharmacies / parapharmacies, the sponsor planned to distribute the questionnaires to users that have purchased the product through health professionals (pharmacists), who are normally in charge of the distribution of the products.
The questionnaire was prepared in simple and easily understandable language for lay people.
The data requested during the filling of the questionnaire does not provide for the collection of information that allows the sponsor an identification of the participant.
Data will be collected and processed in a totally anonymous form.
- Conditions
- Sore-throat, Pharyngitis
- Being tested
- KalobaGOLA spray (1), KalobaGOLA spray (2), KalobaGOLA tablets
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KalobaGOLA spray (1)Device
Oral spray, 2-4 spray, till 8 times per day
KalobaGOLA spray (2)Device
Oral spray, 2-4 spray, till 4 times per day
KalobaGOLA tabletsDevice
1 tablets, 6 times per day
| Study group | Role | What they receive |
|---|---|---|
| Adolescents and adults | Adolescents from 12 years old and adults with sore throat and/or pharyngitis, who have bought the product. Receives: Device: KalobaGOLA spray (1); Device: KalobaGOLA tablets | |
| Children 1-6 years | Children from 1 to 6 years old with sore throat and/or pharyngitis, whose parents/caregivers have bought the product. Receives: Device: KalobaGOLA spray (2) | |
| Children 6-12 years | Children from 6 to 12 years old with sore throat and/or pharyngitis, whose parents/caregivers have bought the product. Receives: Device: KalobaGOLA spray (1); Device: KalobaGOLA tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of the symptoms of sore throat / pharyngitis
A 7-items close question questionnaire developed based on STAT-10 (Sore Throat Assessment Tool-10), a validated and published questionnaire. It is a five-points scale with values from 1 to 5 (1= not at all; 5 = very high degree).
Measured: Before use and at the resolution (after maximum 7 days)
Secondary outcomes (1)
Rate of known and unknown side-effects and / or other risks associated to the use of medical devices
Safety of the devices during and after use
Measured: During and after use (from the first application to after maximum 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start2 Aug 2023
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sore-throatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schwabe Pharma Italia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985837
- Sponsor's protocol ID
- KG-01-2023
- Acronym
- PMCF
- Status last verified
- Apr 2024
- First submitted
- 2 Aug 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-Up Study on Medical Devices KalobaGola Useful for Sore Throat and/or Pharyngitis in Adults and Children
- ClinicalTrials.gov ID
- NCT05985837
- Acronym / sponsor ID
- PMCF / KG-01-2023
- Conditions
- Sore-throat, Pharyngitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Schwabe Pharma ItaliaIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational PMCF study is to confirm the efficacy and safety of the medical device KalobaGola (oral spray and tablets) in children, adolescents and adults with sore throat and /or pharyngitis. The main questions it aims to answer are:
- Is the product effective in the treatment of sore throat / pharyingits?
- Is the product safe?
After buying the product, participants will be asked to fill in a questionnaire, in order to:
- Assess the sore throat symptoms before the use of the spray or tablets.
- Assess the resolution of sore throat / pharyngitis symptoms after the use of the spray or tablets.
- Describe the adverse effect(s)/problem(s) observed while using the product (if any).
Detailed description
The Medical Device Regulation (EU) 2017/745 (MDR) considers post-market clinical follow-up (PMCF) as a continuous process that aims to update the clinical evaluation and validate or reassess the benefit-risk balance of the medical device. The PMCF is an integral part of the manufacturer's post-market surveillance plan (PMS).
The medical devices in question are both CE marked since 2020, with no substantial modification.
The objectives of this Post Market Clinical Follow Up (PMCF) study are: verify the use of these devices in a real situation, verify if their efficacy and safety of use are aligned with the provisions of the clinical evaluation; confirm or reassess the benefit/risk balance; update the risk analysis; identify any need for CAPA.
Specific product questionnaires have been developed based on the validated STAT-10 questionnaire, which aim to investigate aspects of Real-World Evidence on efficacy, safety, even in specific categories or situations, known and unknown adverse events, difficulties in use or completeness and clarity of IFUs.
Given the low-risk class of the devices (class IIa - Dir. 93/42/EEC), which are intended for use by lay people and normally sold in pharmacies / parapharmacies, the sponsor planned to distribute the questionnaires to users that have purchased the product through health professionals (pharmacists), who are normally in charge of the distribution of the products.
The questionnaire was prepared in simple and easily understandable language for lay people.
The data requested during the filling of the questionnaire does not provide for the collection of information that allows the sponsor an identification of the participant.
Data will be collected and processed in a totally anonymous form.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adolescents and adults | – | Device: KalobaGOLA spray (1), Device: KalobaGOLA tabletsAdolescents from 12 years old and adults with sore throat and/or pharyngitis, who have bought the product. |
| Children 1-6 years | – | Device: KalobaGOLA spray (2)Children from 1 to 6 years old with sore throat and/or pharyngitis, whose parents/caregivers have bought the product. |
| Children 6-12 years | – | Device: KalobaGOLA spray (1), Device: KalobaGOLA tabletsChildren from 6 to 12 years old with sore throat and/or pharyngitis, whose parents/caregivers have bought the product. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Customers of the pharmacies/parapharmacies involved
Key inclusion criteria (2 listed)
- KalobaGOLA spray: children from 1 year, adolescents and adults, both sexes, with symptoms of sore throat (burning sensation, pharyngitis, pain on swallowing), who / whose parents or caregivers bought the product by the pharmacy/parapharmacy involved.
- KalobaGOLA tablets: children from 6 years, adolescents and adults, both sexes, with symptoms of sore throat (burning sensation, pharyngitis, pain on swallowing), who / whose parents or caregivers bought the product by the pharmacy/parapharmacy involved.
Key exclusion criteria (2 listed)
- KalobaGOLA spray: children aged < 1 year, people without sore throat symptoms
- KalobaGOLA tablets: children aged < 6 years, people without sore throat symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KalobaGOLA spray (1)Oral spray, 2-4 spray, till 8 times per day | Device | Adolescents and adults, Children 6-12 years |
| KalobaGOLA spray (2)Oral spray, 2-4 spray, till 4 times per day | Device | Children 1-6 years |
| KalobaGOLA tablets1 tablets, 6 times per day | Device | Adolescents and adults, Children 6-12 years |
Primary outcome
Resolution of the symptoms of sore throat / pharyngitis
Time frame: Before use and at the resolution (after maximum 7 days)
A 7-items close question questionnaire developed based on STAT-10 (Sore Throat Assessment Tool-10), a validated and published questionnaire. It is a five-points scale with values from 1 to 5 (1= not at all; 5 = very high degree).
1 secondary outcome
Rate of known and unknown side-effects and / or other risks associated to the use of medical devices
Time frame: During and after use (from the first application to after maximum 7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sore-throat and Pharyngitis, run by Schwabe Pharma Italia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of the symptoms of sore throat / pharyngitis (time frame: Before use and at the resolution (after maximum 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.