A randomised, multi-centre, parallel group, double-blind, placebo- and active-controlled clinical study to assess the efficacy and safety of Octenidine lozenges in the treatment of acute sore throat.

Cassella-med GmbH & Co KG0 个研究点开始时间: 2012年8月9日最近更新: 2016年2月8日

适应症

试验速览

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•-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

•-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.

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