Ibuprofen Lozenge in Acute Sore Throat Pain

Pierre Fabre

Status and phase

Completed

Phase 3

Conditions

Acute Sore Throat Pain

Treatments

Drug: Ibuprofen 25 mg

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01785862

V00498 TA 3 01

2012-004423-20 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

427 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)