Ibuprofen lozenge in acute sore throat pain

• Research type

  Research Study

• Full title

  STUDY OF EFFICACY AND SAFETY OF V0498 VERSUS PLACEBO IN ACUTE SORE THROAT PAIN Multicenter, randomised, placebo-control parallel groups study

• IRAS ID

  119307

• Contact name

  Gordon Crawford

• Sponsor organisation

  Centre de Recherche et Développement Pierre Fabre

• Eudract number

  2012-004423-20

• Research summary

  Sore throat caused by upper respiratory tract infection is one of the most common complaints encountered in clinical practice. In at least 65% of cases, the infection that causes the sore throat is thought to be viral in nature. Antibiotics agents therefore have no place as treatment solution. Non-steroid anti-inflammatory drugs, such as ibuprofen have been widely used for many decades to treat acute pain. The analgesic efficacy of ibuprofen in sore throat pain has been proven in adults after oral administration of 200 and 400mg per dose to a maximum daily dose of 1200 mg/day. This study aims at documenting the efficacy and safety of 25mg ibuprofen lozenges as a local analgesic drug in patients with tonsillopharyngitis.

• REC name

  Scotland A REC

• REC reference

  12/SS/0231

• Date of REC Opinion

  14 Jan 2013

• REC opinion

  Further Information Favourable Opinion