Status:
COMPLETED
Post Market Clinical Follow-Up Study - Medical Device KalobaGOLA ( PMCF )
Lead Sponsor:
Schwabe Pharma Italia
Conditions:
Sore-throat
Pharyngitis
Eligibility:
All Genders
1+ years
Brief 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 p...
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 benef...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- KalobaGOLA spray: children aged \< 1 year, people without sore throat symptoms
- KalobaGOLA tablets: children aged \< 6 years, people without sore throat symptoms
Key Trial Info
Start Date :
August 2 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05985837
Start Date
August 2 2023
End Date
October 31 2023
Last Update
April 17 2024
Active Locations (1)
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1
Schwabe Pharma Italia
Neumarkt, Bolzano, Italy, 39044