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

Inclusion criteria

• Males and females of at least 18 years of age
• Onset of common cold within the last 3 days (12 to 72 hours)
• History of at least 4 symptoms associated with URTI in the last 24 hours out of runny nose, stuffy nose, sneezing, wet cough, dry cough, sweating, earache, ear fullness, sinus pressure/pain, head heaviness, muscle aches and pains, feverish discomfort, chills, hoarseness, sore throat, scratchy throat and headache as documented in the history of URTI
• Current sore throat confirmed by a score ≥ 6 on a 11-category vertical ordinal scale for sore throat pain
• Findings that confirmed the presence of tonsillopharyngitis

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