Post Market Clinical Follow-Up Study - Medical Device KalobaGOLA ( PMCF )

NCT05985837 | Completed

• 1 other identifier: KG-01-2023
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Sore-throat; Pharyngitis

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  During and after use (from the first application to after maximum 7 days)

Study Arms (3)

Adolescents and adults

Adolescents from 12 years old and adults with sore throat and/or pharyngitis, who have bought the product.

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.

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.

Device: KalobaGOLA spray (1); Device: KalobaGOLA tablets

Interventions

KalobaGOLA spray (1) DEVICE

Oral spray, 2-4 spray, till 8 times per day

Adolescents and adults; Children 6-12 years

KalobaGOLA spray (2) DEVICE

Oral spray, 2-4 spray, till 4 times per day

Children 1-6 years

KalobaGOLA tablets DEVICE

1 tablets, 6 times per day

Adolescents and adults; Children 6-12 years

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Customers of the pharmacies/parapharmacies involved

You may qualify if:

• 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.

You may not qualify if:

• KalobaGOLA spray: children aged \< 1 year, people without sore throat symptoms
• KalobaGOLA tablets: children aged \< 6 years, people without sore throat symptoms

Sponsors & Collaborators

• Schwabe Pharma Italia: lead

Study Sites (1)

Schwabe Pharma Italia

Neumarkt, Bolzano, 39044, Italy

Location

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 14, 2023
• Study Start: August 2, 2023
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

IT (1)