MedDRA - 10033481 MedDRA - 10020201
Conditions
Interventions
Group 1: Application of junior-angin N Lutschtabletten (lozenges)
Group 2: Intake of junior-angin N SIRUP (syrup)
Sponsors
MCM Klosterfrau Vertriebsgesellschaft mbH
Eligibility
Sex/Gender
All
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Children from 2 years and adolescents up to 17 years old (junior-angin N SIRUP) or 2. Children from 4 years and adolescents up to 17 years old (junior-angin N Lutschtabletten), respectively; 3. Presence of sore throat/hoarseness as a symptom of an acute infection of the upper respiratory tract or other irritation causing conditions since = 48 hours; 4. Satisfactory general health status except for the upper respiratory tract infection according to the assessment of the investigator; 5. Written informed consent (for minors also from one/both parent(s)); 6. Willingness to comply with intake specifications of the medical device, the study procedures and completion of the patient diary; 7. Confirmed diagnosis justifying the application of the medical device for the treatment of the complaints.
Exclusion criteria
Exclusion criteria: 1. Children younger than 2 years and adults older than 18 years (junior-angin N SIRUP) or 2. Children younger than 4 years and adults older than 18 years (junior-angin N Lutschtabletten), respectively; 3. Pregnant or breastfeeding women; 4. Known allergy/hypersensitivity against one of the ingredients; 5. Presence of a contraindication as listed in the instructions for use; 6. Presence of any sign for a bacterial infection requiring treatment with systemic antibiotics; 7. Any painful disorder that can distract attention from sore throat (e.g. mouth ulcers) or that requires application of analgesics; 8. Surgical interventions in the mouth and throat before inclusion in the study; 9. Parallel participation or planned parallel participation in clinical investigation or observational studies; 10. Earlier participation in this PMCF-study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Observation of disease-related symptom/intensity change in the course of Treatment; 2. Global assessment of effectiveness of the treatment by the patient/physician. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Onset of effectiveness after the first application; 2. Incidence of adverse events (AEs); 3. Global assessment of tolerability of the treatment by the patient/physician; 4. Compliance of the applicants with the therapy; 5. Global assessment of taste. | — |
Countries
Germany
Contacts
Public ContactUdo Schäfer
NO-Praxis Dr. med. Schäfer
Outcome results
None listed