Phase II study of AZD2423 in posttraumatic neuralgia

• Research type

  Research Study

• Full title

  A Phase IIa, Double-blind, Randomised, Parallel-group, Multi-centre Study to Evaluate the Analgesic Efficacy of 28 Days Oral Administration of AZD2423 Compared to Placebo in Patients with Posttraumatic Neuralgia

• IRAS ID

  56935

• Contact name

  stuartratcliffe

• Eudract number

  2010-019785-90

• ISRCTN Number

  N/a

• Research summary

  Neuropathic pain originates in the nervous system and is caused by trauma (e.g. surgery), or diseases such as diabetes or shingles. The pain is either central (such as from the brain or spinal cord) or peripheral (such as from peripheral nerves) depending on the cause of the neuropathic pain. Neuropathic pain is often long lasting and although there are a number of treatments available, many of these are either not very effective or have unacceptable side effects. There is a medical need for better treatment of neuropathic pain. In this study, the experimental drug AZD2423, will be compared to placebo (sugar pill), to see if better pain relief can be provided. Patients with neuropathic pain caused by trauma (accident or surgery) will be investigated.Approximately 135 patients from several European countries and Russia will take part; about 20 patients will be recruited in the UK. The study involves 9 visits over approximately 11 weeks. The treatment period will be for 4 weeks. Male or female patients (of non-child bearing potential) aged 18 to 80 years may be included in the study. Patients will be asked to complete assessments of their pain during the treatment period by electronic diaries and questionnaires. At the visits patients will be asked to give blood samples for routine blood tests and the concentration of AZD2423 in the blood will be measured at four visits. Other assessments will include providing a urine sample, tuberculosis test, chest x-ray, ECG, physical examination and measurement of height, weight, temperature, blood pressure and heart rate.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  10/H0408/63

• Date of REC Opinion

  2 Sep 2010

• REC opinion

  Further Information Favourable Opinion