Active and Placebo Controlled Study to Test the Efficacy and Safety of an Aspirin-Lidocaine Lozenge in the Symptomatic Treatment of Sore Throat Associated With a Common Cold

Exclusion Criteria

• •Pregnancy (i.e. positive pregnancy test at baseline)
• •Breastfeeding
• •History of hypersensitivity (allergic reaction) to ASA or any other NSAID
• •History of hypersensitivity (allergic reaction) to lidocaine
• •History or acute state of peptic ulceration or gastrointestinal bleeding
• •History of bleeding tendency
• •History of asthma
• •Clinical diagnosis of chickenpox or influenza
• •History or presence of severe liver or kidney disease
• •Intake of short-acting analgesics (e.g. ASA, paracetamol, ibuprofen, diclofenac) either as a single ingredient or as part of a combination cold product in the last 6 hours, or intake of long-acting analgesics (e.g. naproxen) in the last 12 hours, or intake of any other NSAID in the last 24 hours
• •Use of any local or systemic short-acting cough and cold preparation (e.g. decongestant or antihistaminic drug) in the last 12 hours
• •Use of any cough or sore throat lozenges/candies or any menthol-containing product (including mentholated tissues) in the last 6 hours
• •Current intake or requirement of any prescription medication for the current treatment of acute respiratory tract illness
• •Administration of anticoagulants in the last 7 days
• •Inability to breathe through the nose or a history of chronic mouth breathing
• •Presence of any severe concomitant disease or condition which, in the opinion of the investigator, is a reason for exclusion, e.g. serious cardiovascular diseases (in particular arrhythmias), treatment with antiarrhythmics or methotrexate