Post Market Clinical Follow-Up Study - Medical Device KalobaGOLA ( PMCF )
NCT ID: NCT05985837
Last Updated: 2024-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
120 participants
OBSERVATIONAL
2023-08-02
2023-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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:
1. Assess the sore throat symptoms before the use of the spray or tablets.
2. Assess the resolution of sore throat / pharyngitis symptoms after the use of the spray or tablets.
3. Describe the adverse effect(s)/problem(s) observed while using the product (if any).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Local Clinical Study for the Comparative Evaluation of Efficacy and Safety of Angal, Lozenges [Menthol] and ANTI-ANGIN® FORMULA, Lozenges, in Treatment of Patients With a Sore Throat
NCT03095521
Ambroxol Lozenges 20mg in Relieving the Pain of Sore Throat in Adolescent Patients With Acute Viral Pharyngitis
NCT00144274
Clinical Study for Comparative Assessment of Efficacy and Safety of Angal S, Topical Spray and ANTI-ANGIN® FORMULA, Topical Metered Spray in Treatment of Patients With Uncomplicated Acute Infectious and Inflammatory Diseases of the Pharynx, Accompanied by a Sore Throat
NCT03095508
Efficacy and Safety Study of New Ambroxol Hardboiled Lozenges in Acute Pharyngitis
NCT03583658
A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis
NCT01048866
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Adolescents and adults
Adolescents from 12 years old and adults with sore throat and/or pharyngitis, who have bought the product.
KalobaGOLA spray (1)
Oral spray, 2-4 spray, till 8 times per day
KalobaGOLA tablets
1 tablets, 6 times per day
Children 1-6 years
Children from 1 to 6 years old with sore throat and/or pharyngitis, whose parents/caregivers have bought the product.
KalobaGOLA spray (2)
Oral spray, 2-4 spray, till 4 times per day
Children 6-12 years
Children from 6 to 12 years old with sore throat and/or pharyngitis, whose parents/caregivers have bought the product.
KalobaGOLA spray (1)
Oral spray, 2-4 spray, till 8 times per day
KalobaGOLA tablets
1 tablets, 6 times per day
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
KalobaGOLA spray (1)
Oral spray, 2-4 spray, till 8 times per day
KalobaGOLA spray (2)
Oral spray, 2-4 spray, till 4 times per day
KalobaGOLA tablets
1 tablets, 6 times per day
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* KalobaGOLA tablets: children aged \< 6 years, people without sore throat symptoms
1 Year
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Schwabe Pharma Italia
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Schwabe Pharma Italia
Neumarkt, Bolzano, Italy
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KG-01-2023
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.