About This clinical research study
This healthy volunteer study aims to assess a potential new treatment for neuropathic pain.
Pain is a complex medical condition with multiple contributing factors. It is the most common reason for medical consultation in most developed countries and can have a strong impact on persons daily living and quality of life.
Neuropathic pain can occur if the nervous system is damaged or not working correctly. Examples include trigeminal neuralgia, painful polyneuropathy, postherpetic neuralgia, and central poststroke pain. Neuropathic pain often affects people with diabetes (diabetic polyneuropathy, DPN). Currently, 200 million people worldwide suffer from DPN. Current treatment options have limited success in relieving neuropathic pain and healthy volunteers are required to help assess potential new treatments in the early phase of research.
The purpose of this trial is to assess and compare two doses of study medication, IP2015 against pregabalin and placebo.
The study aims to provide proof that IP2015 will relieve pain induced following application of capsaicin.
You should not be suffering from pain to take part in this study.
£2675 plus reasonable travel expenses
Clinics
Teesside
Therapy Area
Healthy Volunteers
Gender and Age
Males aged between 18 - 55
A full description of the study will be given before you decide to take part, both over the phone and during an appointment at a MAC clinic. This will include you receiving the full patient information sheet and an opportunity to ask the study doctor any questions.
If you contact us, it does not mean you have to decide at that point whether to participate.
If you do decide to participate you are free to withdraw at any time.
The study involves 2 x screening visits, 4 x 1-night residential stays, 1 x follow up visit.
One of the screens will be a capsaicin screening. Capsaicin is an active molecule in hot chilli peppers. It will test how well the study medication relieves pain caused by capsaicin injections. You must be able to tolerate capsaicin and have a skin type compatible with capsaicin measurements to take part in this trial.
Reimbursement: £2675 plus reasonable travel expenses
Key Inclusion Criteria
- Male aged 18 to 55
- BMI 18 to 30 kg/m2
- Body weight at or over 50 kg
- Be in good health as determined by medical and psychiatric history, medical examination, ECG and blood tests
Key Exclusion Criteria
- Concerns about having blood taken
- Currently using certain prescription or over the counter (OTC) medications
- Unable to tolerate capsaicin or skin type incompatible with capsaicin tests
- Smoker of more than 5 cigarettes a day (or equivalent e-cigs)
Other eligibility criteria will apply. Please contact MAC for more information.
If you are eligible, you will receive a comprehensive health screen. Your GP will be fully informed of your participation and provided with any information relevant to your healthcare.
ABOUT CLINICAL RESEARCH STUDIES
Clinical research studies are performed as a way of bringing about progress in medicine and research. Clinical research studies make it possible to scientifically assess the properties of a drug, to demonstrate the effectiveness and safety of a treatment or a medical device, or to learn more about a disease and methods to diagnose and monitor it.
If the study is successful, it may be an important step towards developing a promising new treatment.
MAC Clinical Research is currently conducting a new clinical research study for Male Healthy Volunteers.
If you would like more information, please fill in the form below and we will be in touch…
Alternatively, please call our recruitment team on freephone 0800 633 5507.
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