A study to test the non-inferiority of Auden local anaesthetic cream

• Research type

  Research Study

• Full title

  A phase I, randomised, double-blind, placebo-controlled, crossover, pilot and therapeutic non-inferiority study of EMLA® and Auden McKenzie local anaesthetic creams in healthy male and female volunteers undergoing forearm cannulation.

• IRAS ID

  62210

• Contact name

  Salvatore Febbraro

• Sponsor organisation

  Auden McKenzie (Pharma Division) Ltd.

• Eudract number

  2010-022024-76

• ISRCTN Number

  1

• Research summary

  A new anaesthetic cream, known as Auden McKenzie test cream, is being developed by the pharmaceutical company (Auden McKenzie (Pharma Division) Ltd.) as an alternative to existing treatments. Auden McKenzie test cream is made from the exact same ingredients as an anaesthetic cream which has been on the market for over 10 years, EMLA© cream. Like EMLA© cream, the new test cream is a local anaesthetic which is designed to be applied to an area of the body where its numbing effects are desired.During this study, Auden McKenzie test cream will be compared to EMLA© cream and to placebo cream (a ??dummy treatment? which looks identical and contains no anaesthetic ingredients). It is hoped that the new test cream will provide anaesthetic effects which are no less than the effects of EMLA© cream, and that both creams have a better anaesthetic effect than the placebo cream. The study will be conducted in 2 Parts:?½ Part A: Pilot study comparing EMLA© cream and Placebo cream over 1 treatment period.?½ Part B: Main study comparing EMLA© cream, Placebo cream and the Auden McKenzie Test cream over 3 treatment periods. Each cream will be applied to a 3cm x 3cm area on the participant's forearm for a period of 2 hours. Venous cannulation will subsequently be performed (in the area of cream application) in order to test the anaesthetic effects of each of the creams. During venous cannulation, a needle will be used to insert a small plastic tube into a vein in the forearm. Participants will be asked to mark, along a scale, the intensity of any pain felt during the procedure. During the study, skin assessments and adverse events will be monitored.

• REC name

  Wales REC 1

• REC reference

  10/WSE04/41

• Date of REC Opinion

  24 Sep 2010

• REC opinion

  Further Information Favourable Opinion