Ibuprofen Lozenge in Acute Sore Throat Pain

Study of Efficacy and Safety of V0498 Versus Placebo in Acute Sore Throat Pain.

The purpose of this study is to evaluate the efficacy and safety of repeated doses of a low dosage of oromucosal Ibuprofen form (lozenge) versus placebo in patients suffering from acute sore throat pain.

Inclusion Criteria:

• male or female aged at least 18 years old
• patient with an acute sore throat

Exclusion Criteria:

• Severe respiratory tract infection (pneumonia, bronchitis or laryngitis)
• Oro-pharyngeal paresthesia or mycosis
• Severely traumatised and/or very severe oromucosal inflammation
• Tonsillopharyngectomy
• Peritonsillar abscess
• Hypersensitivity to ibuprofen or other NonSteroidal Anti-Inflammatory Drugs (NSAIDs) (including bronchospasm) or to excipients
• Long term use (≥ 3 times per week within the last month or regular intake within the last 3 months before randomisation) of antiinflammatory drugs- Any long-acting or slow release analgesic intake including NonSteroidal Anti-Inflammatory Drugs (NSAIDs)within 24 hours before randomisation (e.g. piroxicam or naproxen)
• Any anti-inflammatory drugs intake by systemic route within 12 hours before randomisation
• Any paracetamol intake within 6 hours before randomisation
• Any cold medication (decongestant, antihistamine, expectorant, antitussive) within 6 hours before randomisation
• Any topical throat medication intake containing or not a local oral anaesthetic such as lozenge, spray, mouth rinse within 4 hours before randomisation
• Heavy smokers (>20 cigarettes/day)