E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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
|
|
E.2.2 | Secondary objectives of the trial |
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 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | 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) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 30 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
End of trial is defined as the last study visit of the last patient. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |