Acute Pharyngitis
Conditions
Interventions
Product Name: Benzocain containing lozenge
Pharmaceutical Form: Lozenge
Current Sponsor code: KLF/K/01105
Other descriptive name: Benzocain
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
MCM Klosterfrau GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age: at least 18 years - Acute, viral pharyngitis (no longer than 48 h) with slight to severe pain - Writen informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Bacterial acute pharyngitis - Chronic respiratory tract diseases - Known hypersensitivity against the ingrediance of the test medication - Pregnancy or nursery - Alcohol and/or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Proof of the non-inferiority of a new developed benzocain containing lozenge in comparison to Anaestesin pastilles with regard to efficacy and safety in patients with acute pharyngitis;Secondary Objective: Assessment of pain by the patient by means of the VAS (visual analogue scale) before and directly after sucking of a lozenge/pastille.;Primary end point(s): Number of patients, showing a 50% pain reduction according to the VAS corresponding to a responder rate after dissolution of the first tablet/pastille, but not later than 15 minutes after the start of sucking. | — |
Countries
Germany
Outcome results
None listed