J02
Conditions
Interventions
Group 1: Following inclusion of eligible patients, assessment of severity of the symptoms of interest is performed by physicians at visit 1. Afterwards patients apply the medical device three times da
Sponsors
G. Pohl-Boskamp GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Signed informed consent form and data protection form Patient is aged = 18 years Patients is suffering an acute pharyngitis with throat pain Patient is read, write and speak German.
Exclusion criteria
Exclusion criteria: - Contraindications for GeloTonsil® (Allergy or hypersensitivity to any of the ingredients, current application of other mouth and throat medicines and the lack of ability to gargle safely) - Pregnancy or breastfeeding - Sore throat persisting longer than 5 days - Centor score = 3 (probability to find group A streptococcal infections (GAS) in throat swab – fever >38°, absent from coughing, swollen anterior cervical lymph nodes, Tonsil exudates; one point for each accordance) - Patients requiring antibiotic treatment for any condition at study entry - Parallel participation in another study, participation in a study within less than 6 weeks prior to study entry, or previous participation in this same study - Employee or direct relative of an employee of the investigational site or of the study sponsor - Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, history of drug abuse, known to be non-compliant or presenting an unstable psychiatric history) - Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of sore throat as asssessed by the patient based on a 5-Point Likert-Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient’s daily self-assessment of severity of following clinical symptoms/signs: - Difficulties in swallowing - Scratchy throat - Cough - Dry throat - Additional assessment by physician on V1 and 2 - Throat redness - Throat swelling - Onset of treatment effect - Duration of treatment effect based on reoccurrence of symptoms - Duration of the protective film after application of GeloTonsil® - Coverage of areas of the oral cavity (pharynx, tonsils, tongue, soft palate, hard palate) assessed by physician on V1 after the first application of GeloTonsil® - Assessment of improvement of patient’s satisfaction with therapy by = 1 point on a 5-point Likert scale after end of treatment. - Global assessment of the effectiveness by the physician and patient (5-point Likert scale) - Daily assessment of PGI-I (Patient global impression of improvement, 5-point range between +2 and -2) by patients in eDiary - Criteria & methods for safety/tolerability: - Adverse events/drug reactions, discontinuations (and reasons thereof) - Global assessment of the safety/tolerability by the physician and patient (5-point Likert scale) Global assessment of acceptance and patient’s satisfaction with the product | — |
Countries
Germany
Contacts
Public ContactHans Behrbohm
Park-Klinik Weißensee
Outcome results
None listed