AVANT Neuropathic Pain Study
Research type
Research Study
Full title
A Phase IIa randomised, double-blind, placebo controlled, parallel group, multicentre study evaluating the efficacy, safety, tolerability and pharmacokinetics of AZD1386 after 3 weeks of treatment in patients with Posttraumatic Neuralgia (PTN) and Postherpetic Neuralgia (PHN).
IRAS ID
25261
Contact name
Stuart Ratcliffe
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2009-012094-35
ISRCTN Number
N/a
Research summary
Neuropathic pain is caused by a disease or wound affecting the nervous system, which can be caused by a trauma e.g. surgery, or by a disease such as diabetes or shingles. The pain is either central (situated in the centre of the nervous system) or peripheral (situated outside the central nervous system) depending on the cause of the neuropathic pain. Neuropathic pain is often persistent 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 AZD1386, will be compared to placebo (sugar pill), to see if better pain relief can be provided. Patients with neuropathic pain caused from either shingles or a trauma (accident or surgery) will be investigated.
Approximately 90 patients from several European countries and Canada will take part; about 40 patients will be recruited in the UK. The study involves 7 visits (8 visits if you are a fertile woman) over approximately 6 weeks. The treatment period will be for 3 weeks. Patients will be asked to complete assessments of their pain during the treatment period, both by electronic diaries and paper questionnaires. At the visits patients will be asked to give blood samples for routine blood tests and the concentration of AZD1386 in the blood will be measured at two visits. Other assessments will include providing a urine sample, ECG, physical examination and measurement of height, weight, temperature, blood pressure and heart rate.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
09/H0402/76
Date of REC Opinion
11 Aug 2009
REC opinion
Further Information Favourable Opinion