PHARMACODYNAMIC EFFECT OF DSP-2230 USING PAIN MODELS

• Research type

  Research Study

• Full title

  A RANDOMISED, DOUBLE-BLIND, PLACEBO CONTROLLED, 4 WAY CROSSOVER, 2 PART STUDY INVESTIGATING THE PHARMACODYNAMIC EFFECT OF DSP 2230 USING THE ID CAPSAICIN AND UVB MODELS IN HEALTHY MALE SUBJECTS, USING PREGABALIN AND IBUPROFEN LYSINE AS POSITIVE CONTROLS

• IRAS ID

  118197

• Contact name

  Peter Dewland

• Sponsor organisation

  Dainnippon Sumitomo Pharma Europe Ltd.

• Eudract number

  2012-002568-28

• ISRCTN Number

  to be registered

• Research summary

  Neuropathic (nerve) pain is a significant clinical problem for which the existing treatments are often ineffective or poorly tolerated and therefore there is a need to develop more effective and better tolerated treatments for this type of pain. The investigational study drug DSP-2230 is being developed by the sponsor, Dainippon Sumitomo Pharma Europe Ltd. as an intended treatment for a very painful condition caused by a disease in the nerves called peripheral neuropathy. This study will explore the pharmacodynamic effect of DSP-2230 using Capsaicin and UVB radiation pain models. Part 1: In Part 1 of the study, it is expected that up to 28 participants will be administered capsaicin, the ??hot?? chemical substance found in chilli peppers. The intradermal (into the skin) injection of capsaicin can produce a redness of the skin by activating nerves that release substances responsible for the formation of localised flare/redness accompanied by pain and increased sensitivity. Because of this, it is believed that the intradermal injection of capsaicin may be useful as an experimental pain model. In this part of the study, the participants will be administered DSP-2230 and placebo and the control drug Pregabalin and placebo. Part 2: In Part 2 of the study, it is expected that up to 28 participants will take part in the UVB Pain Model - It has been shown that ultraviolet radiation (UVR) like a sun lamp is a simple and reliable method for causing a temporary inflammatory response in the skin of healthy participants. UVB radiation produces an area of redness (called erythema) similar to a sunburn like response and also causes increased sensitivity to pain. Because of this, it is believed that UVB may be useful as a pain model to test. The participants will be administered DSP-2230 and placebo and the control drug Ibuprofen Lysine and placebo.

• REC name

  Wales REC 2

• REC reference

  12/WA/0350

• Date of REC Opinion

  5 Dec 2012

• REC opinion

  Further Information Favourable Opinion