Strepsils Plus and Strepsils Extra Efficacy Study TH1017 29Nov10

• Research type

  Research Study

• Full title

  A multi centre, randomised, double blind, single dose parallel group, placebo controlled study to investigate the efficacy of Strepsils Plus and Strepsils Extra in the treatment of sore throat due to upper respiratory tract infection.

• IRAS ID

  69716

• Contact name

  Damien McNally

• Sponsor organisation

  Reckitt Benckiser Healthcare

• Eudract number

  2010-024045-69

• ISRCTN Number

  Not applicable

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a multi centre, randomised, double blind, single dose, parallel group, placebo controlled study, looking at the efficacy of Strepsils Plus and Strepsils Extra in the treatment of a sore throat due to upper respiratory infection. 180 patients will take part in this study and they will be allocated equally to one of 3 treatment groups to receive either:One Strepsils Plus lozengeOne Strepsils Extra LozengeOne non medicated sugar based placebo lozenge. Patients with a sore throat will be identified either by their opportunistic presentation at a participating surgery or by responding to a poster advertisement in their local area. If they meet the required criteria they will be asked to read the patient information sheet, ask any questions they wish and then sign the consent form. A wash out period between 02 and 24 hours may be required depending on whether they have taken any other pain relief or sore throat medication or boiled sweets.Before they take the lozenge the doctor will perform a physical examination concentrating on the eyes, ears, nose, mouth and lungs and an assessment will be made of their sore throat. Patients will be asked to sit in a quiet room, observed by a study nurse and they will be given one lozenge to suck slowly. They will not be allowed to eat or drink anything in this 2 hour period. They will be asked to complete various rating scales and questionnaires during the 2 hour observation period. Once this 2 hour period is completed patients will be given a patient diary and they will be asked to note down any adverse events or other medications they take after they leave the surgery. The study nurse will phone them within the next 1-3 days to review the diary with them on the phone and record this information.

• REC name

  HSC REC A

• REC reference

  10/NIR01/74

• Date of REC Opinion

  16 Dec 2010

• REC opinion

  Favourable Opinion