About This clinical research study
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. Current treatment options only have limited success in relieving acute and chronic pain and those experiencing painful conditions often have depression, anxiety, and sleep disorders.
The purpose of this study is to test a drug called ketoprofen lysine salt (KLS) in combination with gabapentin, or KLS-GABA (the ‘study drug’) that is being developed for the treatment of pain.
You must not be suffering from pain to take part in this study.
With your participation you may be contributing to the development of new treatment options for people living with painful conditions.
£1085 plus travel expenses or transport reimbursed
Clinics
Greater Manchester Early Phase Unit
Therapy Area
Healthy Male 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.
128 healthy male participants will take part in the trial at the Greater Manchester clinic.
The study will require:
2 x Screening visits (a medical screening and a capsaicin screening). Capsaicin is an active molecule in hot chilli peppers. Capsaicin stimulates the receptors in sensory nerves and leads to temporary localised pain. You must be able to tolerate capsaicin and have a skin type compatible with capsaicin measurements to take part in this trial. The study aims to assess how well the study medication relieves pain caused by capsaicin injections.
1 x 1-night residential stay
1 x follow up visit
Reimbursement: £1085 plus travel expenses or transport reimbursed
Key Inclusion Criteria
- Males aged 18 – 55
- BMI 18 – 32
- Body weight at or over 50 kg
- Skin Type compatible for capsaicin measurements e.g., fair/light skin – Mediterranean/olive skin. No tattoos or dermatological skin conditions on either forearm
- Must be in good health as determined by medical and psychiatric history, medical examination, ECG and blood tests
Key Exclusion Criteria
- Concerns about having injections or having blood taken
- Currently using any prescription or non-prescription medications (OTC). Occasional use of paracetamol is permitted
- Active chronic pain condition(s) or a history of chronic pain conditions
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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