A clinical study to assess the efficacy and safety of Octenidine lozenges in the treatment of acute sore throat. Octenedine Lozenges will be compared with an active comparator and against placebo in patients at multiple sites, in a double blind ( patient and doctor) randomised manner.

• Conditions: Acute pharyngitis; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-002876-15-DE
• Lead Sponsor: Cassella-med GmbH & Co KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-09
• Last Update Posted: 8 February 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified