Pennine Acute Trust screens the first UK participant to a diabetes trial
RESEARCH nurses at The Pennine Acute Hospitals NHS Trust have screened the first participant in the UK to a diabetes trial.
The team of specialist nurses identified the first patient who was seen at The Royal Oldham Hospital.
The Pennine Acute Trust is testing a new medication to reduce nerve pain in people with diabetes. Nerve damage (neuropathy) can be a complication of diabetes in some people. Neuropathic pain is often debilitating and is described by patients as burning, stabbing, shooting or like having an electric shock.
The purpose of the phase 2a study is to find out if a new investigational medication, when given together with gabapentin or pregabalin is effective and safe in reducing pain intensity in patients suffering from neuropathic pain of diabetic origin. Pregabalin and gabapentin are approved prescription medicines that are used to treat neuropathic pain.
The new investigational product is a type of drug known as a DENKI inhibitor and works by enhancing the body’s natural pain control mechanism involving endorphins. The drug has not yet been approved for the treatment of neuropathic pain and is considered experimental.
The study is a ‘double-blind, randomised placebo controlled trial’ which means that patients will have a 50% chance (like tossing a coin) of receiving either PL37 or a placebo as additional treatment to their gabapentin or pregabalin. Neither the doctor nor patient will know which treatment group they are in to avoid bias.
Participants will visit the Trust hospital five times over a five week period to be assessed and will also have to record the intensity of their pain every day on an electronic diary system.
The study medication is taken for 28 days in total.
Professor Deepak Bhatnagar is the study’s Principal Investigator and he is supported by three research nurses: Joanne Shaw, Judy Muir and Louise Morby (pictured).
Professor Bhatnagar said: “This is an interesting study of an experimental drug that works by enhancing the body’s own mechanisms to deal with nerve pain.”
Notes to editor
The Trust is committed to research and transformation as a driver for improving the quality of care it provides to patients. It enables staff and the wider NHS, regionally and nationally, to improve the current and future health outcomes of people. ‘Clinical research’ means research which has received a favourable opinion from a research ethics committee within the National Research Ethics Service (NRES). The Trust currently support 382 research studies. Of these studies, 75 are clinical trials involving medicinal products. During 2014/15, the Trust recruited patients to 108 National Institute for Health Research Clinical Research Network (NIHR CRN) clinical research studies.