France, Germany, Latvia427 participantsStarted 2013-02
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)