Acute pharyngitis
Conditions
Interventions
Product Name: Octenidine lozenges
Pharmaceutical Form: Lozenge
INN or Proposed INN: Octenidine hydrochloride
CAS Number: 70775-75-6
Concentration unit: mg milligram(s)
Concentration type: range
Conce
Sponsors
Cassella-med GmbH & Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age between 12 and 65 years, signed informed consent -Sore throat for a maximum of 36 hours, short-term adjuvant treatment indicated. -Inflammation of the mucosa of the mouth and throat with typical symptoms like pain, reddening and swelling, to be verified by the investigator by means of: - a physical examination - a Tonsillo-Pharyngitis Score >2 -Pain on two 10 cm visual analogue scales (VAS) (pain at rest and pain when swallowing) at day 0 of at least 10 cm (sum of both VAS). At least 4 cm on each of both VAS. - On-site test for streptococcus negative Are the trial subjects under 18? yes Number of subjects for this age range: 85 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 615 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Fever>38°C and/or multiple swollen anterior lymph nodes - Fever>38°C and/or multiple swollen anterior lymph nodes - Purulent tonsillitis and/or rash according to the investigator's clinical judgement - Treatment with systemic antibiotics within the last 7 days - Treatment with any antiseptics, analgesics, local anaesthetics, ambroxol, bromhexin or codeine within the last 12 hours - Actual need for treatment with systemic antibiotics - Allergy to Octenidine or ingredients of neo-angin® (Levomenthol, 2,4-Dichlorbenzylalcohol, Amylmethacresol, Peppermint Oil, Glucose or Sucrose) - Present gastrointestinal diseases or gastrointestinal diseases in the anamnesis which may be regarded as pre-disposition for adverse effects of orally administered antiseptics, e.g. gastrointestinal diseases associated with diarrhoeas and/or imbalances of the microbiological colonisation of the gastrointestinal tract - Diabetes, malignomas, severe infections like hepatitis A, B, C, HIV, tuberculosis - Other diagnoses that could interfere with the study diagnosis or therapy - Immunosuppressive therapy within 2 months prior to study start or during study - Addiction to alcohol or drugs - Pregnancy or lactation - Participation in a further clinical trial at the same time or within the last 4 weeks prior to inclusion into the present study. All exclusion criteria referring to clinical aspects are to be verified by the investigator during a physical examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives are to demonstrate superiority of Octenidine lozenges compared with placebo in terms of rate of responders, and to demonstrate non-inferiority of Octenidine lozenges compared with active comparator (neo angin®) in terms of the rate of responders. Response is defined as a score of 4 or 5 on the Pain Relief Rating Scale (PRRS) (patient assessment) at visit 3 (study day 3 or 4, LOCF) and a total score of 0 or 1 on the Tonsillo-Pharyngitis Score (TPS) (investigator assessment) at visit 3 (study day 3 or 4, LOCF). Both primary objectives are efficacy objectives ;Secondary Objective: Secondary efficacy objective is to compare Octenidine, matching placebo and active comparator in terms of: -Pain Relief Rating Scale (PRRS): rate of patients with pain relief at visits 2 and 3 and at study day 2 -Tonsillo-Pharyngitis Score (TPS): rate of patients with improvement at visit 2 and visit 3 -Tonsillo-Pharyngitis Score (TPS): mean change from baseline at visit 2 and visit 3 - Visual Analogue Scales (VAS): mean change from baseline at visit 2 and visit 3 The other secondary (safety) objective is to compare Octenidine, matching placebo and active comparator in terms of - adverse events - local adverse reactions according to pre-specified list - results of the physical examination;Primary end point(s): The primary endpoint is a combination of pain relief (assessed by the patient) and reduction of inflammation (assessed clinically by the investigator);Timepoint(s) of evaluation of this end point: 4 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -;Timepoint(s) of evaluation of this end point: 4 days | — |
Countries
Germany
Contacts
Public ContactDr Christian Nauert
Cassella-med GmbH & Co KG
Outcome results
None listed