Ibuprofen Lozenge in Acute Sore Throat Pain

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pierre Fabre Medicament
• Treatments: Ibuprofen

Criteria

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)