0.6 mg AMC and 1.2 mg DCBA Lozenges Pilot Efficacy Study

• Research type

  Research Study

• Full title

  A multi-centre, randomised, double blind, placebo-controlled, parallel group, single dose, pilot study of the efficacy of 0.6 mg Amylmetacresol BP (AMC) and 1.2 mg 2,4-Dichlorobenzyl alcohol (DCBA) throat lozenges in the relief of sore throat due to upper respiratory tract infection.

• Sponsor organisation

  Reckitt Benckiser Healthcare (UK) Limited

• Eudract number

  2008-005059-67

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The main objective of this study is to determine if AMC alone and DCBA alone will provide pain relief to patients with sore throats as a result of an upper respiratory tract infection (URTI). This is a multicentre, randomised, double blind, parallel group, placebo controlled, single dose pilot study examining the effectiveness of 0.6mg AMC only lozenges and 1.2mg DCBA only lozenges in relieving sore throats. Eligible subjects (150 subjects- 50 in each treatment group) who consent to take part will be randomised to one of three treatment groups: 1. AMC only lozenges, containing 0.6mg AMC 2. DCBA only lozenges, containing 1.2mg DCBA 3. Non-medicated sugar based placebo lozenges Patients will remain at the research site for 2 hours for evaluation following dosing. They will have to complete different questionnaires assessing the effectiveness of the study treatment. After 2 hours the patients will be discharged. They will be provided a diary to record any adverse events and will be asked to return 1-3 days later for a follow-up visit.

• REC name

  HSC REC B

• REC reference

  08/NIR03/84

• Date of REC Opinion

  4 Nov 2008

• REC opinion

  Further Information Favourable Opinion